title: A Phase III, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared With Physician's Choice of Adjuvant Endocrine Monotherapy in Patients With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer

summary: This is a Phase III, global, randomized, open-label, multicenter, study evaluating the efficacy and safety of adjuvant giredestrant compared with endocrine therapy of physician's choice in participants with medium- and high-risk Stage I-III histologically confirmed estrogen receptor (ER)-positive and human epidermal growth factor receptor 2 (HER2)-negative early breast cancer.

ipd_sharing_description:
Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).

For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

lead_sponsor: Hoffmann-La Roche

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
Ukraine
United States
Costa Rica
Peru
Belgium
Japan
Philippines
Romania
South Africa
Czechia
Poland
Hong Kong
Portugal
Slovenia
Austria
Australia
Russian Federation
Argentina
India
Israel
Turkey
Mexico
Malaysia
Sweden
Slovakia
Kenya
Bosnia and Herzegovina
Brazil
Canada
Switzerland
Guatemala
Hungary
North Macedonia
China
Germany
Taiwan
Greece
Georgia
Ireland
Latvia
Finland
Thailand
Uganda
Korea, Republic of
France
Chile
Colombia
Netherlands

location_facility: Clinica de Pesquisas e Centro de Estudos Oncologia Ginecologica e Mamaria Ltda

location_facility: Rocky Mountain Cancer Centers (Longmont) - USOR

location_facility: MI of Zaporizhzhia Regional Council Zaporizhzhia Regional Clinical Oncology Dispensary

location_facility: The Second Affiliated Hospital of Zhejiang University School of Medicine

location_facility: Centrum Onkologii im. Prof. F. Lukaszczyka w Bydgoszczy

location_facility: Soon Chun Hyang University Cheonan Hospital

location_facility: Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale

location_facility: Sparsh Hospitals & Critical Care (P) Ltd.

location_facility: Fondazione Policlinico Universitario A Gemelli; Farmacia Interna

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Penn State Univ. Milton S. Hershey Medical Center; Department of Investigational Drug Services

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Regional Clinical Oncology Dispensary Novosibirsk

location_facility: Centro Hospitalar do Porto - Hospital de Santo António; Oncologia

location_facility: Timisoara Emergency County Clinical Hospital

location_facility: Instituto de Investigaciones Metabólicas (IDIM); Diabetes

location_facility: Harbin Medical University Cancer Hospital

location_facility: Praxis fuer gynaekologische onkologie Prof. Dr. me

location_facility: Westmead Hospital; Pharmacy Distribution Centre

location_facility: Consorci Hospital General Universitari de València

location_facility: Irmandade Da Santa Casa de Misericordia de Porto Alegre; Hospital Dom Vicente Scherer

location_facility: Fundação Faculdade Regional de Medicina de São José do Rio Preto

location_facility: Mammazentrum Hamburg am Krankenhaus Jerusalem

location_facility: Instituto de Oncologia Clínica de Piracicaba

location_facility: Barts and The London School of Medicine and Dentistry - Barts Cancer Institute (BCI)-CECM

location_facility: Zuyderland Medisch Centrum; Trialbureau Poli Interne Geneeskunde

location_facility: USOR - Texas Oncology - San Antonio Northeast

location_facility: Nemocnice AGEL Novy Jicin a.s.; Oddeleni radioterapie a onkologie

location_facility: Istanbul University Cerrahpasa Medical Faculty Hospital; Klinik Arastırma Merkezi

location_facility: Brust-Zentrum Zürich AG Seefeldstrasse 214 Zürich

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Centrum Medyczna Ostroleka - PRATIA - PPDS

location_facility: Medical Clinical Research Center of Medical Center LLC Health Clinic

location_facility: Facharztpraxis für Gynäkologie und Geburtshilfe PD Dr. med. Christian Kurbacher

location_facility: Memorial Healthcare System - Memorial Regional Hospital

location_facility: Centro Polivalente de Asistencia e Investigación Clínica - CER San Juan

location_facility: PHI Clinical Hospital Dr Trifun Panovski Bitola

location_facility: Institute for Oncology and Radiology of Serbia

location_facility: Fundación CENIT para la Investigación en Neurociencias

location_facility: University of Kentucky; Markey Cancer Center

location_facility: Oö. Gesundheits- und Spitals-AG/LKH Steyr

location_facility: Instituto Brasileiro De Controle Do Câncer - IBCC; Laboratório De Patologia

location_facility: Centro Medico Integral de Cancerologia CEMIC

location_facility: Valley Breast Care and Women's Health Center

location_facility: Universidade de Caxias do Sul - Rio Grande do Sul

location_facility: Spital STS AG Thun - Berner Oberland ; Onkologie Zentrum

location_facility: Centre Jean Bernard Clinique Victor Hugo

location_facility: The First Affiliated Hospital of Xiamen University

location_facility: Medizinische Universitat Wien Medical University of Vienna

location_facility: Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy

location_facility: Kinghorn Cancer Centre; Pharmacy Department

location_facility: Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz

location_facility: Seoul National University Bundang Hospital

location_facility: Massachusetts General Hospital; Lurie Center for Autism

location_facility: Instituto Nacional de Cancer - INCa; Oncologia

location_facility: Stefanie Spielman Comprehensive Breast Center

location_facility: Centro de Investigaciones Clinicas Viña del Mar

location_facility: Himalaya Cancer Hospital & Research Institute

location_facility: Chulalongkorn Hospital; Medical Oncology

location_facility: Mater Hospital; Patricia Ritchie Centre for Cancer Care and Research

location_facility: Hospital Universitario Clínico San Cecilio

location_facility: Centro de Investigación Clínica - Clínica Viedma

location_facility: Metropolitan Hospital Fourth Oncology Clinic

location_facility: Centro Odonito Medico Linus Pauling - Clinica de O

location_facility: Azienda Ospedaliera Universitaria Senese

location_facility: Chopda Medicare & Research Centre pvt. Ltd

location_facility: Centro Oncologioco MD Anderson Internacional; Servicio de Farmacia

location_facility: Centrum Terapii Wspolczesnej J.M.Jasnorzewska Spolka Komandytowo-Akcyjna

location_facility: Skaraborgs sjukhus Skoevde, Dept of surgery

location_facility: University College London Hospitals; Clinical Research Facility

location_facility: Sahyadri Super Specialty Hospital Hadapsar

location_facility: Hospital Senhora da Oliveira - Guimaraes, E.P.E

location_facility: Hämatologie und Onkologie Ravensburg / Wangen

location_facility: SI Institute for general and urgent surgery n.a. V.T.Zaitseva of NAMS of Ukraine

location_facility: Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi

location_facility: Centro Hospitalar Trás Os Montes E Alto Douro EPE

location_facility: UNIVERSITATSKLINIKUM ERLANGEN; Department of Gynecology and Obstetrics

location_facility: Communal Nonprofit Enterprise Kyiv City Clinical Oncological Center

location_facility: Changhua Christian Medical Foundation Changhua Christian Hospital

location_facility: Communal Non-Profit Enterprise Chernihiv Medical Center of Modern Oncology of CRC

location_facility: Clínica Médica Especializada en Hematología

location_facility: Kantonsspital Winterthur Medizin Pneumologie

location_facility: Hämatologisch/onkologische Gemeinschaftspraxis; Dres. Brudler/Heinrich/Bangerter

location_facility: Centro Hospitalar Lisboa Norte, E.P.E. - Hospital de Santa Maria; Servicos Farmaceuticos

location_facility: University of Santo Tomas Hospital; Pharmacy

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP

location_facility: Azienda Ospedaliero Universitaria di Bologna Policlinico S.Orsola-Malpighi

location_facility: Kliniken Essen Mitte Evang. Huyssens Stiftung/Knappschaft GmbH

location_facility: Baguio General Hospital and Medical Center

location_facility: Sujan Surgical Cancer Hospital And Amravati Cancer Foundation

location_facility: Luzerner Kantonsspital LUKS; Studienzentrale Onkologie

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Institute Jules Bordet; Med Onc & Translational Rsch

location_facility: Centro de Investigación en Artritis y Osteoporosis - PPDS

location_facility: East Avenue Medical Center; Breast Care Center

location_facility: Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe

location_facility: Gangnam Severance Hospital, Yonsei University Health System

location_facility: Hospital Universitario HM Sanchinarro - CIOCC; Farmacia - Ensayos Clínicos

location_facility: Centro de Oncologia da Bahia; Centro Médico Iguatemi

location_facility: PHI University Clinic of Radiotherapy and Oncology; Breast malignancy

location_facility: GZA Ziekenhuizen Antwerpen campus Sint-Augustinus

location_facility: Treatment and Diagnostic Center of LLC Specialized Clinic Prognosis Optima

location_facility: State Cancer Institute, Indira Gandhi Institute of Medical Sciences (IGIMS)

location_facility: Hospital Universitario Juan Ramon Jimenez

location_facility: Narodowy Instytut Onkologii im. M.Skłodowskiej-Curie - Państwowy Instytut Badawczy Oddział Gliwice

location_facility: Riga East Clinical University Hospital Latvian Oncology Centre

location_facility: The Catholic University of Korea Seoul St. Mary's Hospital

location_facility: Koo Foundation Sun Yat-Sen Cancer Center

location_facility: Hospital General Universitario de Alicante

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Centrum Onkologii Ziemi LUBELSKIEJ im. Sw Jana z Dukli, I oddz. Chemioterapii

location_facility: Hemato Oncology Clinic Ahmedabad Pvt Ltd

location_facility: Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi

location_facility: KLES Dr Prabhakar Kore Hospital and Medical Research Centre

location_facility: Private Healthcare Institution Clinical Hospital RZhD Medicine

location_facility: Joliet Oncology Hematology Associates, Ltd.

location_facility: Narodowy Instytut Onkologii - Panstwowy Instytut Badawczy, Oddział w Krakowie

location_facility: Universitaetsklinikum Carl Gustav Carus an der TU Dresden

location_facility: Waterford Regional Hospital; Department Of Medical Oncology

location_facility: Municipal Non-profit Enterprise Zhytomyr Regional Oncology Dispensary of Zhytomyr Regional Council

location_facility: General Oncology Hospital Kifissias "Oi Agioi Anargyroi"

location_facility: Fundacion Instituto Valenciano de Oncologia (IVO)

location_facility: Hospital General Universitario Morales Meseguer; Servicio de Neurología

location_facility: Yonsei University Wonju Severance Christian Hospital

location_facility: Pauls Stradins Clinical University Hospital

location_facility: North Coast Cancer Institute - Port Macquarie

location_facility: Complejo Hospitalario Universitario de Albacete

location_facility: Hospital HM Nuestra Señora de la Esperanza

location_facility: SRH Wald-Klinikum Gera; Brustzentrum Ostthüringen

location_facility: Instituto de Oncologia de Sorocaba - CEPOS

location_facility: University of Athens Medical School - Regional General Hospital Alexandra

location_facility: Hospital Universitario Virgen de Las Nieves

location_facility: Regionalny Szpital Specjalistyczny im. W. Bieganskiego; Oddział Onkologii Klinicznej

location_facility: Universitätsklinikum Aachen AÖR - Medizinische Fakultät der RWTH

location_facility: Cardinal Santos Medical Center; Department of Internal Medicine, Section of Endocrinology

location_facility: Sociedad de Investigaciones Medicas Ltda (SIM)

location_facility: CaritasKlinikum Saarbruecken St Theresia

location_facility: Shalinitai Meghe Medical College and Hospital

location_facility: Consultorio Oncologico-Hospital Metropolitano San

location_facility: Martin Luther Universitat Halle Wittenberg

location_facility: Instituto de Investigación en Ciencias Médicas S.A.

location_facility: Kiran Hospital Multi Super Speciality Hospital and Research Center

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti

location_facility: Hirslanden Klinik St. Anna Brustzentrum/Chirurgie

location_facility: Hospital Nossa Senhora da Conceição; Ambulatório de Pneumologia

location_facility: CBCC Global Research Inc., at Comprehensive Blood and Cancer Center

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Fondazione del Piemonte per l'Oncologia (IRCCS)

location_facility: Fakultni Thomayerova Nemocnice; Onkologicke Oddeleni

location_facility: Centre Hospitalier Universitaire de Sherbrooke

location_facility: The Affiliated Hospital of Xuzhou Medical University

location_facility: Medical Oncology Centre of Rosebank; Oncology

location_facility: Praxis fur Haematologie und Internistische Onkologie

location_facility: Kailash Cancer Hospital and Research Center

location_facility: Ospedale San Vincenzo Taormina :Divisione di Oncologia Medica

location_facility: Gynäkologisch Onkologische Praxis Hannover

location_facility: Centro de Investigacion Medica Aguascalientes

location_facility: Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E.

location_facility: Prof Dr I Chiricuta Institute of Oncology; Oncology Department

location_facility: Cliniques Universitaires UCL de Mont-Godinne

location_facility: The Second People's Hospital of Neijiang

location_facility: Klinikum Mannheim GmbH Universitätsklinikum

location_facility: Consultorio Oncologico-Hospital Metropolitano Linc

location_facility: University of Florida; UF Health Shands Cancer Hospital

location_facility: Universitätsklinikum St. Pölten; Klinische Abteilung für Innere Medizin 1

location_facility: Institut de Cancérologie Strasbourg Europe

location_facility: Guangdong Provincial Maternity and Child Care Cent

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Hospital Universitario Reina Sofia; Servicio de Farmacia

location_facility: EVEX Clinics, Saint Nikolozi Medical Centre

location_facility: UPMC Williamsport, Divine Providence Campus

location_facility: Hacettepe Universitesi Tip Fakultesi Hastanesi; Ic Hastaliklari Anabiim Dali

location_facility: Froedtert and The Medical College of Wisconsin

location_facility: Oncology Associates at Mercy Medical Center

location_facility: Instituto de Especialidades de la Salud Rosario - Clínica del Tórax

location_facility: Instituto Medico de la Fundacion Estudios Clinicos

location_facility: Excellentis Clinical Trial Consultants; Clinical Research

location_facility: Spitalul Clinic de Obstetrica si Ginecologie Filantropia; Sectorul 1 BUCUREȘTI

location_facility: Liverpool Hospital; Cancer Therapy Centre

location_facility: Centrum fur Hamatologie und Onkologie Bethanien

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: Clinica Universidad Navarra; Servicio de Farmacia

location_facility: Universitätsspital Bern; Departement Herz & Gefässe

location_facility: Centro de Investigaciones Medicas Mar Del Plata

location_facility: Oncology Associates of Oregon, P.C.; Willamette Valley Cancer Institute

location_facility: Ltd Israel-Georgia Medical Research Clinic Helsicore

location_facility: Torrance Memorial Physician Network/Cancer Care

location_facility: National Hospital Organization Osaka National Hospital

location_facility: The Cancer Institute Hospital of Japanese Foundation For Cancer Research

location_facility: Hospital Universitario Fundacion Jimenez Diaz.

location_facility: Clínica Integral Internacional de Oncología S de RL de CV

location_facility: Social Medical Corporation Hakuaikai Sagara Hospital

location_facility: University General Hospital of Heraklion

location_facility: Wesley Medical Centre; Clinic For Haematology and Oncology

location_facility: Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialita San Giuseppe Moscati

location_facility: Oncology and Hematology Associates of Southwest Virginia, Inc.,-Blacksburg

location_facility: Cenantron - Centro Avancado de Tratamento Oncologico

location_facility: Metro-Minnesota Community Oncology Research Consortium

location_facility: Medizinische Universitat Innsbruck; Department of Internal Medicine, Pneumology Centre

location_facility: Arcispedale Santa Maria Nuova; Oncologia

location_facility: T.C. Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin City Hospital

location_facility: The Center for Cancer Prevention and Treatment at St.Joseph Hospital of Orange

location_facility: Clinical Center University of Sarajevo; Oncology Institute

location_facility: Lokmanya Holistic Cancer Care and Research Center (LMRC)

location_facility: Institute of Post Graduate Medical Education and Research (IPGMER) and SSKM Hospital

location_facility: EDOG - Centre Eugene Marquis Centre Regional de Lutte Contre Le Cancer - PPDS

location_facility: Fundacion Arturo Lopez Perez; Quimioterapia

location_facility: *X*Fundação Pio XII Hospital de Câncer de Barretos

location_facility: Centro Di Riferimento Oncologico; Clinical Trial Office

location_facility: Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS

location_facility: Joe Arrington Cancer Research & Treatment Center

location_facility: Memorial Health University Cancer Center

location_facility: University of Maryland; St. Joseph Medical Center

location_facility: Sandton Oncology Medical Group (Pty) Ltd

location_facility: Univerzitna nemocnica s poliklinikou Milosrdni bratia spol s r o

location_facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez

location_facility: University Hospital Medical Center Bezanijska kosa

location_facility: SPbGU Medical and diagnostic center of the clinic of high medical technology n a N I Pirogov

location_facility: Instituto de Investigaciones Clinicas-Mar del Plata

location_facility: Hsin-Chu Branch of National Taiwan University Hospital

location_facility: Centro de Educación Médica E Investigaciones Clínicas Cemic; Rheumatology

location_facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology

location_facility: Hospital de Clinicas de Porto Alegre (HCPA) - PPDS

location_facility: Baskent Universitesi - Adana Uygulama Ve Arastirma Merkezi

location_facility: Kocaeli Universitesi Tip Fakultesi Arastirma ve Uygulama Hastanesi

location_facility: Hospital Clinico Universitario de Valladolid; Servicio de Oncologia

location_facility: CIUSSS de l'Est-de-l'Ile-de-Montréal - Hôpital Maisonneuve-Rosemont

location_facility: Municipal Non-profit Enterprise Odessa Regional Clinical Hospital of Odessa Regional Council

location_facility: University of Missouri-Columbia; Ellis Fischel Cancer Center

location_facility: Szpital Morski Im. Pck; Oncology & Radiotherapy Dept

location_facility: Acıbadem Adana Hospital, Oncology Department

location_facility: ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda

location_facility: First Affiliated Hospital of Medical College of Xi'an Jiaotong University

location_facility: Regional Municipal Non-Commercial Enterprise Bukovynian Clinical Oncology Center

location_facility: Centro de Pesquisas Clinicas em Oncologia - CPCO

location_facility: Hospital Universitario Insular de Gran Canaria

location_facility: Mackay Memorial Hospital - Taipei Branch

location_facility: Papageorgiou General Hospital of Thessaloniki

location_facility: University Hospitals Cleveland Medical Center

location_facility: Townsville Hospital; Pharmacy Department

location_facility: Metropolitan Hospital First Oncology Clinic

location_facility: Centro Oncologico Riojano Integral (CORI)

location_facility: Centro Hospitalar de Vila Nova de Gaia / Espinho E.P.E

location_facility: CliniOnco - Clinica de Oncologia de Porto Alegre; Departamento de Pesquisa

location_facility: Virginia Commonwealth University - Massey Cancer Center

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Saint Louis University Hospital of Sacred Heart

location_facility: Centre Hospitalier Departemental de Vendee

location_facility: Wenzhou Medical College - The First Affiliated Hospital GCP

location_facility: Sociedad de Oncología y hematología del Cesar Ltda

location_facility: Complejo Hospitalario de Navarra; Servicio de Farmacia

location_facility: Sir Mortimer B Davis Jewish General Hospital

location_facility: Consorcio Hospitalario Provincial de Castellon

location_facility: Interbalkan Medical Center of Thessaloniki

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: Katip Celebi University- Izmir Ataturk Egitim ve Arastirma Hastanesi

location_facility: Centre Integre Universitaire de Sante et de Services Sociaux du Saguenay Lac Saint Jean

location_facility: Azienda ULSS 8 Berica; Oncologia Medica - Ospedlae di Vicenza

location_facility: Istituto Oncologico Veneto - I.R.C.C.S.; U.O.C. Farmacia con Produzione di Farmaci Antiblastici

location_facility: A.ö. Krankenhaus der Barmherzigen Brüder

location_facility: Stamford Hospital; Clincal Trials Office - 1st Fl - Bennett Cancer Cente

location_facility: Nuovo Ospedale di Prato S. Stefano - Azienda USL Toscana Centro

location_facility: The Municipal Enterprise Volyn Regional Medical Oncology Centre of the Volyn Regional Council

location_facility: Taipei Medical University Shuang Ho Hospital

location_facility: General Hospital Djordje Joanovic - Zrenjanin

location_facility: Centro de Investigacion Clinica de Oaxaca

location_facility: Hospital Universitario Fundación Alcorcón


title: Real World Effectiveness of Upadacitinib on Early and Sustained Pain Control in Radiographic Axial Spondylarthritis (UPSTAND)

acronym: UPSTAND

summary:
Axial spondyloarthritis (axSpA) is an immune-mediated inflammatory disease primarily affecting the axial skeleton. The most frequent axSpA symptom is chronic, often inflammatory back pain (IBP) that might be difficult to distinguish from other causes of chronic back pain (CBP). Many participants report persistent pain, including back pain, which impacts disease activity and quality of life including creating burdens such as sleep disturbance, social isolation, loss of productivity, as well as anxiety and depression. Despite this, there is a lack of detailed data and knowledge on pain in radiographic-axial spondyloarthritis (r-axSpA), including pain types, how it is localized, and how these different facets of pain are impacted by treatment. This study will assess the real-world effectiveness of upadacitinib on early and sustained pain control, and the association between pain and clinical/patient-reported outcomes in radiographic axSpA participants.

Upadacitinib is being developed for the treatment of r-axSpA. Approximately 877 adult participants with activer-axSpA will be enrolled across approximately 19 countries in Europe, North America, South America, and Asia-Pacific.

Participants will receive oral upadacitinib tablets as prescribed by the physician prior to enrolling in this study in accordance with the terms of the local marketing authorization and professional and reimbursement guidelines with regards to dose, population and indication. The overall duration of the study is approximately 30 months.

There may be a higher burden for participants in this study compared to usual standard of care. Participants will attend regular visits per routine clinical practice. The effect of the treatment will be checked by medical assessments, checking for side effects, and questionnaires.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

ipd_sharing: Undecided

lead_sponsor: AbbVie

location_country:
Kuwait
Poland
Spain
Greece
Russian Federation
Australia
Mexico
Argentina
Canada
Switzerland
Hungary
Uruguay
France
Israel
Belgium
Bulgaria
United Arab Emirates

location_facility: Regional Clinical Hospital of Kaliningrad region /ID# 238475

location_facility: Tel Aviv Sourasky Medical Center /ID# 241864

location_facility: Centre Hospitalier Universitaire du Sart Tilman CHU de Liege /ID# 231440

location_facility: Hospital Universitario Virgen del Rocio /ID# 249038

location_facility: CHU Montpellier - Hôpital Saint Eloi /ID# 240980

location_facility: CHU Lille - Hôpital Roger Salengro /ID# 228820

location_facility: University General Hospital of Patras /ID# 243795

location_facility: Military Medical Academy n.a. Kirov /ID# 242363

location_facility: ASIMP Rheumatology Centre "St. Irina" EOOD /ID# 249789

location_facility: Nort-Western State Medical University n.a. Mechnikov /ID# 231172

location_facility: Arthur Karasik Medicine Professional Corporation /ID# 241932

location_facility: The Baruch Padeh Medical Center Poriya /ID# 249797

location_facility: CHU de Besancon - Jean Minjoz /ID# 242499

location_facility: Clinic of Samara State Medical University /ID# 241166

location_facility: Euromedica Blue Cross Gen Clin /ID# 244945

location_facility: University General Hospital of Heraklion PA.G.N.I /ID# 241124

location_facility: Lau Bacchus Professional Medicine Corp /ID# 242591

location_facility: Clinical Rheumatologic Hospital No 25 /ID# 231171

location_facility: CHD Vendée- La Roche-sur-Yon - Les Oudairies /ID# 230947

location_facility: Hospital Clinico Universitario Virgen de la Arrixaca /ID# 249042

location_facility: CHU Clermont Ferand - Hopital Gabriel Montpied /ID# 229092

location_facility: Centro Especializado en Diabetes, Obesidad y Prevencion de Enfermedades Cardiova /ID# 238817

location_facility: Ulyanovsk Regional Clinical Hospital /ID# 238334

location_facility: CHU Toulouse - Hopital Purpan /ID# 228818

location_facility: GBUZ RM "Mordovia Republican Central Clinical Hospital" /ID# 244738

location_facility: Debreceni Egyetem Klinikai Kozpont /ID# 239936

location_facility: Yaroslavl State Medicat University /ID# 231168

location_facility: Hospital Virgen de la Concha /ID# 249026

location_facility: Clinica de Investigacion en Reumatologia y Obesidad S.C. /ID# 238815

location_facility: Hospital Universitario de Jaen /ID# 249041

location_facility: CHU de Rennes - Hospital Sud /ID# 228842

location_facility: Desarrollos Biomedicos y Biotecnologicos /ID# 238818

location_facility: 424 General MILITARY Hospital /ID# 241127

location_facility: "Ambulatory for individual practice of specialized medical help for internal dis /ID# 249791

location_facility: AP-HM - Hopital Sainte Marguerite /ID# 241024

location_facility: Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji /ID# 243232

location_facility: General Hospital of Thessaloniki Hippokrateio /ID# 243796

location_facility: Hevizgyogyfurdo es Szent Andras Reumakorhaz /ID# 239940

location_facility: Hadassah Medical Center-Hebrew University /ID# 241865

location_facility: Applied Medical Informatics Research Inc. (AMIR) /ID# 246284

location_facility: CHR Orleans - Hopital de la Source /ID# 234258

location_facility: "Prof. Anastas Batalov AIPSMP-VBR" EOOD /ID# 249788

location_facility: Chelyabinsk Regional Clinical Hospital /ID# 244741

location_facility: Investigacion y Biomedicina de Chihuahua /ID# 238813

location_facility: Centre de Soins Osteoarticulaires Ambulatoires /ID# 244737

location_facility: Orenburg State Medical University /ID# 233183

location_facility: Jerzy Świerkot Indywidualna Specjalistyczna Praktyka Lekarska /ID# 244289

location_facility: Paratus Clinical Research Woden /ID# 231460

location_facility: CHU Bordeaux - Hopital Pellegrin /ID# 230548

location_facility: The Chaim Sheba Medical Center /ID# 241305

location_facility: General Hospital of Athens Laiko /ID# 241128

location_facility: CHU de Besancon - Jean Minjoz /ID# 230528

location_facility: Szpital Specjalistyczny im. J. Dietla w Krakowie /ID# 243228

location_facility: Moscow Regional Research and Clinical Institute n.a. Vladimirskiy (MONIKI) /ID# 232510

location_facility: Hospital Universitario Canarias /ID# 249043

location_facility: AP-HP - Hopital Saint-Antoine /ID# 228795

location_facility: Departnent of Medicine-Rheumatology Al Baraha Hospital and Al Qasmi Hospital Min /ID# 250479

location_facility: Cliniques Universitaires de Bruxelles Hopital Erasme /ID# 238961

location_facility: Groupe de Recherche en Maladies Osseuses Inc /ID# 241111

location_facility: Consultorio Privado Jorge Rojas Serrano /Id# 239512

location_facility: Royal Prince Alfred Hospital /ID# 232417

location_facility: Hospital Universitario Virgen Macarena /ID# 249039

location_facility: GH Diaconesses Croix Saint-Simon /ID# 238548

location_facility: General Hospital of Athens Ippokratio /ID# 241133

location_facility: Dr. Sabeen Anwar Medicine Professional Corporation /ID# 241933

location_facility: Rheumatologisches Versorgungszentrum Weinfelden /ID# 239435

location_facility: Research Institute of Rheumatology named after V.A. Nasonova /ID# 238479

location_facility: Centro de Estudios de Investigación Básica y Clínica, S.C. /ID# 238822

location_facility: ChUZ Clinical Hospital RZD-Medicine /ID# 233185

location_facility: Unidad de Investigacion de las Enfermedades Reumatologicas SA de CV /ID# 238824

location_facility: The Lady Davis Carmel Medical Center /ID# 241867

location_facility: Budgetary Institution of the Khanty-Mansiysk Autonomous Okrug-Yugra "Surgut Dist /ID# 242369

location_facility: CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 249765

location_facility: RM Pharma Specialists S.A de C.V. /ID# 238816

location_facility: AP-HP - Hopital Bichat - Claude-Bernard /ID# 228837

location_facility: Nebbiolo Clinical Research Center /ID# 231167

location_facility: CHU de SAINT ETIENNE - Hopital Nord /ID# 228836

location_facility: Magyar Honvedseg Egeszsegugyi Kozpont /ID# 239939

location_facility: Samara Regional Clinical Hospital n.a. V. D. Seredavin /ID# 231169

location_facility: Hospital Universitario Nuestra Señora de Candelaria /ID# 249044

location_facility: CHU Grenoble - Hopital Michallon /ID# 228792

location_facility: Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im. Wiktora Degi /ID# 243225

location_facility: Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz /ID# 239937

location_facility: KAT Atttica General Hospital /ID# 243063

location_facility: Dr. Chrisostomos Kouroukis & Dr. Pauline Boulos MPC /ID# 246213

location_facility: Hôpital d'instruction des armées Bégin /ID# 228793

location_facility: Bács-Kiskun Megyei Kórház Szegedi Tudományegyetem AOK Oktató Kórháza /ID# 239938

location_facility: Republican hospital named after V.A. Baranov /ID# 231173

location_facility: CHU Amiens-Picardie Site Sud /ID# 228821

location_facility: Complejo Hospitalario Universitario de Santiago /ID# 249025

location_facility: CHU Montpellier - Hôpital Saint Eloi /ID# 228829

location_facility: Barwon Rheumatology Services /ID# 230068

lead_sponsor_type: industriel

status_simplified: Ongoing


title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial Comparing the Efficacy and Safety of Tafasitamab Plus Lenalidomide in Addition to R-CHOP Versus R-CHOP in Previously Untreated, High-intermediate and High-risk Patients With Newly-diagnosed Diffuse Large B-cell Lymphoma (DLBCL)

acronym: frontMIND

summary: This is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial designed to compare the efficacy and safety of the humanized monoclonal anti CD19 antibody tafasitamab plus lenalidomide in addition to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) versus R-CHOP in previously untreated, high-intermediate and high-risk patients with newly-diagnosed DLBCL

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

ipd_sharing: No

lead_sponsor: MorphoSys AG

location_country:
Serbia
Spain
Italy
United Kingdom
Ukraine
United States
Romania
Philippines
Japan
Czechia
Poland
Austria
Australia
Russian Federation
Argentina
Israel
Turkey
Malaysia
Slovakia
Canada
Hungary
Germany
Taiwan
Ireland
New Zealand
Thailand
Korea, Republic of
France
Colombia

location_facility:
MorphoSys Research Site
Morphsys Research Site
Morphosys Research Site
Morphosys research site

intervention_type: Drug


title: Evaluation of the Sensitivity and Specificity of a Novel Quality of Life (QoL) Tool to Assess the Treatment Satisfaction in Psoriasis Patients

acronym: PSO-TARGET

summary:
The severity of psoriasis can be influenced by a great variety of factors including extent of the disease, lesions location and impact on quality of life. The current standard of care for psoriasis is focusing on the reduction of the skin symptoms as defined by the PASI, somewhat setting asides the patient's feelings in terms of which aspects of his/her life are affected by the disease. Despite the fact that multiple patient reported outcomes (PRO) questionnaires are available to evaluate the impact of the disease on patients' quality of life, only few items address the subjective impact of skin disease. Among the available PROs the Dermatology Life Quality Index (DLQI) is the most frequently used. It is a standardized tool designed to cover a broad range of dermatologic afflictions but lacks specificity towards the effect of psoriasis on quality of life. The DLQI is composed of ten questions grouped in 6 domains "symptoms and feelings", "daily activities", "leisure", "work/school", "personal relationships" and "treatment". Each answer is graded from 0 to 3. The DLQI score is calculated by adding the score of each question, resulting in a maximum score of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. A score higher than 10 indicates that the patient's life is being severely affected by their skin disease.

Because of its limitations, some patients cannot seem to completely restore a normal quality of life (e.g. DLQI 0-1) even though their reached a perfect PASI score (100). This phenomenon may be explained by the fact that the patient's own perception can be different from the physician's perspective and may have changed in time, between follow-ups. These are as many reasons as why it is highly difficult to accurately fathom the therapeutic expectations of the psoriasis patients. The standard tools currently in use are not able to assess the perception of the disease by the patient its evolution over time. In addition, it is widely recognized that alexithymia is more prevalent in the psoriasis patients than in the general population and patients with alexithymia appear to suffer higher psoriasis burden as they have more difficulties to express their expectations. Since patients struggle to recognize and verbalize their emotions, it can be useful and informative to offer patients a variety of verbatim in which they can identify. PSO-TARGET is an exploratory observational, non-interventional study aiming to evaluate a novel approach of assessing psoriasis patients' satisfaction towards their biologic treatment from a quality of life standpoint by using a psoriasis-specific Quality of Life assessment grid.

The aim of this exploratory study is to evaluate the sensitivity and specificity of the PSO-TARGET QoL Component grid as part of a new approach for assessing the level of achievement of the psoriasis patient's therapeutic goal, identified by himself, after a treatment with Kyntheum®.

lead_sponsor: Clinact

location_country: France Belgium

location_facility: Hôpital d'Instruction des armées SAINTE ANNE

location_facility: Cliniques Universitaires Saint Luc - UCLouvain

intervention_type: Other


title: A 52-week, Randomised, Double-blind, Double-dummy, Parallel Group, Multi-centre, Non-inferiority Study Assessing Exacerbation Rate, Additional Measures of Asthma Control and Safety in Adult and Adolescent Severe Asthmatic Participants With an Eosinophilic Phenotype Treated With GSK3511294 Compared With Mepolizumab or Benralizumab

summary: This study will assess whether switching participants who have benefitted from mepolizumab or benralizumab to GSK3511294 (Depemokimab) is non-inferior to maintaining current treatment on the annualized rate of clinically significant exacerbations in participants with severe asthma with an eosinophilic phenotype. Throughout the study, all participants will continue their non-biologic Baseline standard of care (SoC) asthma treatment.

ipd_sharing: Yes

ipd_sharing_description: IPD for this study will be made available via the Clinical Study Data Request site.

lead_sponsor: GlaxoSmithKline

location_country:
Poland
Taiwan
Slovenia
Ireland
Austria
Australia
Italy
Finland
Canada
Netherlands
Spain
Sweden
Switzerland
Puerto Rico
United States
France
Norway
United Kingdom
Japan
Germany

intervention_type: Biological


type: EudraCT Number

title: Phase III Randomized, Open-Label, Multicenter Study Evaluating Efficacy and Safety of Mosunetuzumab in Combination With Lenalidomide in Comparison to Rituximab in Combination With Lenalidomide in Patients With Follicular Lymphoma After at Least One Line of Systemic Therapy

acronym: Celestimo

summary: This study will evaluate the efficacy and safety of mosunetuzumab in combination with lenalidomide (M + Len) compared to rituximab in combination with lenalidomide (R + Len) in participants with relapsed or refractory (R/R) follicular lymphoma (FL) who have received at least one line of prior systemic therapy.

ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

location_country:
Poland
Taiwan
Brazil
Spain
Italy
Russian Federation
Australia
United Kingdom
Ukraine
Korea, Republic of
United States
France
China
Turkey
Japan
Germany

location_facility: Uniwersytecki Szpital Kliniczny; Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku

location_facility: A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna

location_facility: Centre Antoine Lacassagne;B4 Hematologie Cancerologie

location_facility: Ch Lyon Sud; Hemato Secteur Jules Courmont

location_facility: Instytut Hematologii i Transfuzjologii; Klinika Hematologii

location_facility: City Clinical Botkin's Hospital; City Hematological Center

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Marmara Üniversitesi İstanbul Pendik Eğitim Ve Araştirma Hastanesi

location_facility: Koc Universitesi (KU) Tip Fakultesi (Koc University School of Medicine)

location_facility: Hospital de Donostia; Servicio de Oncologia

location_facility: Hopital De Haut Leveque; Hematologie Clinique

location_facility: Ematologia/immunologia Clinica Azienda Ospedaliera Policlinico di Padova

location_facility: Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

location_facility: Hôpital Saint-Louis; Service d'Hématologie

location_facility: Hopital De La Miletrie; Hematologie Et Oncologie Medicale

location_facility: Universitätsklinikum Halle; Klinik für Innere Medizin IV; Hämatologie und Onkologie

location_facility: Hospital Universitario la Paz; Servicio de Hematologia

location_facility: Szpital Kliniczny im. Heliodora Święcickiego; Oddzial Hematologii i Transplantacji Szpiku

location_facility: Geelong Hospital; Andrew Love Cancer Centre

location_facility: Harbin Medical University Cancer Hospital

location_facility: Regional Clinical Hospital N.A. Semashko; Hematology

location_facility: Ospedali Riuniti Umberto I; Clinica di Ematologia

location_facility: Cancer Center, Sun Yat-sen University of Medical Sciences; Department of Medical Oncology

location_facility: Atakent Acibadem Private Hosptial Halkali Merkez Mh.,

location_facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology

location_facility: Municipal Noncommercial Institution Regional Center of Oncology

location_facility: City of Hope Comprehensive Cancer Center

location_facility: Royal Adelaide Hospital; Haematology Clinical Trials

location_facility: Ospedale Maggiore Di Milano; U.O. Ematologia I - Padiglione Marcora

location_facility: Ospedale Di Circolo E Fondazione Macchi; Ematologia

location_facility: CHU Saint Eloi; Service d'Hématologie Clinique

location_facility: Klinikum Chemnitz gGmbH, Klinik für Innere Medizin III, Hämatologie und Onkologie

location_facility: Universitätsklinikum Augsburg; II. Med. Klinik

location_facility: Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

location_facility: Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia

location_facility: Fudan University Shanghai Cancer Center; Medical Oncology

location_facility: Chang Gung Medical Foundation - Kaohsiung; Oncology; Division of Hematology-Oncology

location_facility: Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical Oncology

location_facility: University Hospital Kyoto Prefectural University of Medicine

location_facility: Hospital General Universitario J.M Morales Meseguer; Servicio de Hematología

location_facility: Karadeniz Technical Uni School of Medicine; Hematology

location_facility: Washington University; Wash Uni. Sch. Of Med

location_facility: The 1st Affiliated Hospital of Nanchang Unversity

location_facility: Marien-Hospital Klinik f.Hämatologie Onkologie u.Palliativmedizin

location_facility: Centre Henri Becquerel; Service Hématologie

location_facility: Universitätsklinik Rostock; Klinik für Innere Med. III, Abteilung Hämatologie/Onkologie

location_facility: Severance Hospital, Yonsei University Health System

location_facility: BAG Freiberg-Richter, Jacobasch, Illmer, Wolf; Gemeinschaftspraxis Hämatologie-Onkologie

location_facility: Gloucestershire Royal Hospital; Haematology Department

location_facility: Oddzial Kliniczny Hematologii SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie

location_facility: National Taiwan Universtiy Hospital; Division of Hematology

location_facility: The First Affiliated Hospital of Xiamen University

location_facility: CHU NANTES - Hôtel Dieu; Service d'Hematologie Clinique

location_facility: Uniklinik Heidelberg, Medizinische Klinik & Poliklinik V

location_facility: Centre Hospitalier de La Cote Basque; Hematologie

location_facility: Wake Forest Univ Health Svcs; Section on Hem and Onc

location_facility: Uni-Klinikum-Schleswig-Holstein; Klinik für Innere Medizin II; Hämatologie und Onkologie

location_facility: The First Affiliated Hospital of Zhengzhou University

location_facility: Seoul National University Bundang Hospital

location_facility: Hopital Henri Mondor; Hematologie Clinique

location_facility: Nottingham City Hospital; Dept of Haematology

location_facility: Johns Hopkins Uni ; Sidney Kimmel Comprehensive Care Center

location_facility: Vivantes Klinikum Am Urban Klinik für Innere Medizin Hämatologie und Onkologie

location_facility: FSBI "National Medical Research Center of Oncology N.N. Blokhin"

location_facility: Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences

location_facility: Cancer & Hematology Center of West Michigan

location_facility: Hacettepe Uni Medical Faculty; Hematology

location_facility: Chang Gung Medical Foundation - Linkou; Division of Hematology- Oncology

location_facility: Klinik und Poliklinik f. Innere Medizin III des Universitätsklinikums Regensburg

location_facility: Universtitätsklinikum Ulm; Klinik für Innere Medizin III

location_facility: Szpitale Pomorskie Sp. z o. o.; Oddział Hematologii i Transplantologii Szpiku

location_facility: Hopital Saint Antoine; Hematologie Clinique

location_facility: Westpfalz-Klinikum GmbH; Innere Medizin 1, Hämatologie und internistischen Onkologie

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Hematologia

location_facility: Giovanni Paolo II/I.R.C.C.S. Istituto Tumori

location_facility: Universitaetsklinikum des Saarlandes; medizinische Klinik und Poliklinik; Innere Medizin I


title: An Observational Retrospective Cohort Study of Systemic Therapies for Relapsed or Refractory Diffuse Large B Cell Lymphoma (R/R DLBCL), to Compare Outcomes to Those From Tafasitamab + Lenalidomide in the L-MIND Study

summary: To compare the efficacy outcomes of the L-MIND cohort with the effectiveness in a matched patient population treated with systemic NCCN/ESMO guideline listed regimens administered in routine clinical care.

status: Completed

study_completion_date_type: Actual

time_perspective: Retrospective

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Nowakowski GS, Yoon DH, Peters A, Mondello P, Joffe E, Fleury I, Greil R, Ku M, Marks R, Kim K, Zinzani PL, Trotman J, Huang D, Waltl EE, Winderlich M, Kurukulasuriya NC, Ambarkhane S, Hess G, Salles G. Improved Efficacy of Tafasitamab plus Lenalidomide versus Systemic Therapies for Relapsed/Refractory DLBCL: RE-MIND2, an Observational Retrospective Matched Cohort Study. Clin Cancer Res. 2022 Sep 15;28(18):4003-4017. doi: 10.1158/1078-0432.CCR-21-3648.

location_country:
Denmark
Taiwan
Spain
Italy
Austria
Australia
United Kingdom
Canada
Korea, Republic of
United States
France
Germany

status_simplified: Completed


title: De-Escalation of Adjuvant Chemotherapy in HER2-positive, Estrogen Receptor-negative, Node-negative Early Breast Cancer Patients Who Achieved Pathological Complete Response After Neoadjuvant Chemotherapy and Dual HER2 Blockade

acronym: Decrescendo

summary:
DECRESCENDO is a multicentre, open-label, dual-phase single-arm phase II de-escalation study evaluating neoadjuvant treatment with 12 administrations of weekly IV paclitaxel 80 mg/m2 (or IV docetaxel 75 mg/m2 every 3 weeks for 4 cycles) combined with subcutaneous (SC) fixed dose combination (FDC) of pertuzumab and trastuzumab (loading dose of 1200 mg pertuzumab and 600 mg trastuzumab, followed by 600 mg pertuzumab and 600 mg trastuzumab) every 3 weeks for 4 cycles.

Surgery will be performed according to local guidelines in all subjects after neoadjuvant treatment.

After surgery, subjects who achieve a pCR (defined as pT0/Tis pN0) will receive adjuvant pertuzumab and trastuzumab FDC SC for additional 14 cycles. Subjects with residual invasive disease will receive salvage adjuvant trastuzumab emtansine (T-DM1, 3.6 mg/kg, IV every 3 weeks) for 14 cycles. In subjects whose residual invasive disease is classified per RCB score as ≥2, 3 to 4 cycles of anthracycline-based chemotherapy may be administered, at the investigator's discretion, before the 14 cycles of T-DM1.

If histopathological analysis finds that the surgical specimen from a subject with residual disease is ER-positive and/or PR-positive, adjuvant endocrine therapy may be administered concomitantly with study treatment, at the investigator's discretion and according to local guidelines.

Adjuvant radiotherapy will be mandatory after breast-conserving surgery, whereas it will be performed according to local guidelines after mastectomy, and it will be administered concomitantly with pertuzumab and trastuzumab FDC SC in subjects who achieve a pCR, and concomitantly with T-DM1 in subjects with residual invasive disease (after anthracycline-based chemotherapy in subjects assigned to receive this treatment).

design_allocation: Non-Randomized

lead_sponsor: Jules Bordet Institute

location_country: Australia France Belgium

location_facility: Institut de Cancérologie de l'Ouest - Angers

location_facility: GZA Ziekenhuisen Campus Sint-Augustinus - Iridium Kankernetwerk

location_facility: Groupe Hospitalier Diaconesses Croix Saint-Simon

location_facility: Centre de Cancerologie du Grand Montpellier


type: Other Identifier

title: Phase 2b Clinical Study Evaluating Efficacy and Safety of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With High-Risk Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guérin (BCG) Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy

summary: The purpose of this study is to evaluate the overall complete response (CR) rate in participants treated with TAR-200 in combination with cetrelimab (Cohort 1), or TAR-200 alone (Cohort 2), or cetrelimab alone (Cohort 3) with Carcinoma in Situ (CIS), with or without concomitant high-grade Ta or T1 papillary disease.

ipd_sharing_description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) project site at yoda.yale.edu

lead_sponsor: Janssen Research & Development, LLC

location_country:
Portugal
Spain
Greece
Italy
Australia
Netherlands
Canada
Russian Federation
United Kingdom
Ukraine
Korea, Republic of
United States
France
Turkey
Belgium
Japan
Germany

location_facility: The Male/Female Health and Research Centre

location_facility: General Hospital of Thessaloniki G. Gennimatas

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Centro Hospitalar de Trás os Montes e Alto-Douro

location_facility: Pusan National University Yangsan Hospital

location_facility: Urological Associates of Southern Arizona, P.C.

location_facility: N. N. Blokhin Russian Academy of Medical Sciences

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: State Institution Academy Of Medical Sciences Of Ukraine

location_facility: The Julius Center - Utrecht Science Park - Stratenum

location_facility: Instituto Portugues de Oncologia do Porto Francisco Gentil

location_facility: Polyclinique de Limoges - Francois Chenieux

location_facility: A. Tsyb Medical Radiological Research Center

location_facility: Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.

location_facility: BHI of Omsk region Clinical Oncology Dispensary

location_facility: Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino

location_facility: Multifunctional clinical medical center 'Medical city'

location_facility: Kyungpook National University Chilgok Hospital

location_facility: The Catholic University of Korea, Seoul St. Mary's Hospital

location_facility: Cherkassy Regional Oncology Dispensary, Department of Hematology

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust

location_facility: FSBHI RSCRST n.a. Ac. Granov A.M. of MoH

location_facility: Istanbul Medeniyet University Goztepe Training and Research Hospital

location_facility: Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari

location_facility: Institut de Cancérologie Strasbourg Europe (ICANS)

location_facility: Yildirim Beyazit University Medical Faculty Ankara Atatürk Research and Training Hospital

location_facility: Oxford University Hospitals NHS Foundation Trust

location_facility: 'Papageorgiou' General Hospital of Thessaloniki

location_facility: Chernihivskyi oblasnyi onkolohichnyi dyspanser

location_facility: Urologic Consultants of Southeastern Pennsylvania

location_facility: Attikon University General Hospital of Attica

location_facility: Kliniken Nordoberpfalz AG/Klinikum Weiden

location_facility: Groupe Hospitalier Diaconesses Croix Saint Simon

location_facility: Ankara Universitesi Tip Fakultesi Cebeci Hastanesi

location_facility: University of Texas Southwestern Medical Center

location_facility: Studienpraxis Urologie Nürtingen - Germany

location_facility: Urologische Praxis am Wasserturm - Germany


title: A Randomized, Open-Label, Phase 3 Trial of Epcoritamab vs Investigator's Choice Chemotherapy in Relapsed/Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL)

lead_sponsor: Genmab

type: Registry Identifier

source: euctr

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Poland
Austria
Australia
Russian Federation
Israel
Turkey
Norway
Singapore
Sweden
Canada
Hungary
China
Germany
Denmark
Taiwan
Finland
Korea, Republic of
France
Netherlands

location_facility: Universitätsklinikum Schleswig-Holstein Medizinische Klinik II Hämatologie und Onkologie

location_facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)

location_facility: East Carolina University, Leo W. Jenkins Cancer Center

location_facility: Ordensklinikum Linz Barmherzige Schwestern

location_facility: Istanbul University Cerrahpasa - Cerrahpasa Tip Fakultesi

location_facility: Beijing Tongren Hospital, Capital Medical University

location_facility: Uniklinik Köln, Klinik I für Innere Medizin, CIO Gebäude 70, 5.094

location_facility: Virginia Commonwealth University (VCU) Massey Cancer Center

location_facility: SC Ematologia - AOU Città della Salute e della Scienza di Torino

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

location_facility: Haematology - University Hospitals Birmingham NHS Foundation Trust

location_facility: Universitair Ziekenhuis gasthuisberg Leuven

location_facility: Federal State Budgetary Institution V.A. Almazov National Medical Research Center of the Ministry of

location_facility: Royal Wolverhampton Nhs Trust, New Cross Hospital

location_facility: Department of Internal Medicine and Hematology, Military Institute of Medicine

location_facility: State Budgetary Institution of Healthcare of Nizhniy Novgorod region, 1st inpatient facility, 5th fl

location_facility: IRCCS Istituto Tumori Giovanni Paolo II Bari

location_facility: ICO Badalona - Hospital Universitari Germans Trias i Pujol

location_facility: Royal Marsden NHS Foundation Trust (Sutton)

location_facility: Norfolk and Norwich University Hospitals NHS Foundation Trust

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

location_facility: TriHealth Cancer Institute- Good Samaritan Hospital

location_facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology

location_facility: Federal State Budgetary Institution of Science

location_facility: Azienda Ospedaliera Universitaria Policlinico Umberto I Università di Roma La Sapienza, Dip Med Tra

location_facility: Guangxi Medical University Affiliated Tumor Hospital

location_facility: Turku University Hospital, Oncology department

location_facility: Medical University of Graz, Division of Hematology

location_facility: Clinical Research Unit, KFE Herlev Hospital

location_facility: Azienda Socio Sanitaria Territoriale Sette Laghi (Presidio Ospedale di Circolo e Fondazione Macchi)

location_facility: State Budgetary Institution of Healthcare of Moscow City Clinical Hospital named after S.P. Botkin o

location_facility: Provincial Hospital in Opole sp. Z o.o Department of Hematology, Hematological Oncology and Internal

location_facility: Azienda Ospedaliero - Universitaria Maggiore delle Carita SCDU Ematologia building C

location_facility: St.-Petersburg Pavlov State Medical University

location_facility: Tianjin Medical University Cancer Institute and Hospital

location_facility: Semmelweis Egyetem Belgyógyászati és Onkológiai Klinika

location_facility: ASST Niguarda (Grande Ospedale Metropolitano Niguarda), S.C. Ematologia - Dipartimento di Ematologia

location_facility: Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI) Ospedale Maggiore di Trieste

location_facility: Semmelweis Egyetem, Belgyógyászati és Hematológiai Klinika

location_facility: Peninsula Private Hospital Clinical Trials Unit

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Belgyógyászati osztály Markhot Ferenc Kórház

location_facility: Japanese Red Cross Nagoya Daini Hospital

location_facility: Szegedi Tudományegyetem II. sz. Belgyogyaszat, Hematologia

location_facility: Josa Andras Teaching Hospital, Hematology Dept

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Amphia Ziekenhuis, Interne Geneeskunde, Oncologie. Route 43

location_facility: IRCCS Ospedale Casa Sollievo della Sofferenza

location_facility: Wojewodzki Szpital Specjalistyczny w Slupsku Sp z o.o Oddzial Hematologiczny

location_facility: Uniklinikum Salzburg, Universitätsklinik für Innere Medizin III der PMU

location_facility: Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi

location_facility: The Second Hospital of Dalian Medical University

location_facility: Maria Sklodowska Curie National Oncology Institute State Research Institute

location_facility: Shengjing Hospital of China Medical University

location_facility: Kuopio University Hospital Cancer Center

location_facility: SC di Ematologia - AON SS Antonio e Biagio e Cesare Arrigo

location_facility: State Autonomous Institution of Healthcare Republican Clinical Oncological Dispensary of the Ministr

location_facility: Indiana Blood and Marrow Transplantation

location_facility: ICO l'Hospitalet - Hospital Duran i Reynals

location_facility: The First Affiliated Hospital of Nanchang University

location_facility: Södra Älvsborgs Sjukhus, Hematolog dagvård

location_facility: Oulu university hospital, Department of hematology

location_facility: Seoul National University Bundang Hospital

location_facility: Aarhus University Hospital, Department of Hematology, Clinical Research Unit C116

location_facility: The Catholic University of Korea Seoul St. Marys Hospital

location_facility: University of Kentucky Markey Cancer Center

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Klinika, Hematologia

location_facility: Uniwersyteckie Centrum Kliniczne, Klinika Hematologii i Transplantologii

location_facility: State Budgetary Institution of Healthcare Leningrad Regional Clinical Hospital

location_facility: State Institution of Healthcare of Tula Region Tula Regional Clinical Hospital

location_facility: University of Pecs 1st. Internal medicine Clinic Dept. Hematology

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Oslo University Hospital location Radium hospital

location_facility: Community Health Network Cancer Center North

location_facility: State Budgetary Institution of Healthcare of Republic Kareliya Republican Hospital named after V.A

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)

location_facility: AZ Nikolaas- Verenigde Ziekenhuizen van Waas en Durme

location_facility: Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii

location_facility: Szent Borbala Hospital, Hematology Department

summary: The drug that will be investigated in the study is an antibody, epcoritamab, also known as GEN3013 . Since the safety and tolerability of epcoritamab has already been studied in previous studies in humans, the main purpose of this study is to evaluate efficacy. To evaluate this, half of the participants who are eligible will receive epcoritamab and the other half will receive a pre-specified investigator's choice of chemotherapy. Epcoritamab will be studied in R/R DLBCL participants who did not respond to a previous autologous stem cell transplant (ASCT) or do not meet the criteria for ASCT


title: A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study of Trastuzumab Deruxtecan (T-DXd) Versus Trastuzumab Emtansine (T-DM1) in Participants With High-Risk HER2-Positive Primary Breast Cancer Who Have Residual Invasive Disease in Breast or Axillary Lymph Nodes Following Neoadjuvant Therapy (DESTINY-Breast05)

lead_sponsor: Daiichi Sankyo, Inc.

ipd_sharing_description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

location_country:
Spain
Italy
United Kingdom
United States
Peru
Belgium
Japan
Romania
Czechia
Poland
Hong Kong
Portugal
Russian Federation
Australia
Argentina
Israel
Turkey
Mexico
Singapore
Brazil
Canada
China
Germany
Denmark
Taiwan
Greece
Ireland
Korea, Republic of
France
Chile
Netherlands

location_facility: CHA Bundang Medical Center CHA University

location_facility: CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia

location_facility: CIUSSSS de l'Est-de-l'Ile-de-Montréal - Installation Hôpital Maisonneuve-Rosemont

location_facility: INCA - Instituto Nacional do Cancer / Hospital do Cancer HCIII

location_facility: Clinique Tivoli Ducos - Centre dOncologie et de Radiotherapie a Bordeaux

location_facility: St John of God Hospital - Bendat Family Comprehensive Cancer Centre (BFCCC)

location_facility: Harbin Medical University Cancer Hospital

location_facility: Osaka International Cancer Institute (OICI)

location_facility: MultiCare Institute for Research & Innovation

location_facility: SRH Waldklinikum Gera, Brustzentrum Ostthüringen

location_facility: Hiroshima City Hiroshima Citizens Hospital

location_facility: SCRI TO Nashville- St. Thomas Midtown Tennessee Oncology, PLLC

location_facility: SCRI TO Nashville- Franklin Tennessee Oncology, PLLC

location_facility: Erasmus MC - Daniel den Hoed Oncologisch Centrum

location_facility: State Budgetary Healthcare Institution Oncological Dispensary No. 2 of the Ministry of Health of Krasnodar Region

location_facility: Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE

location_facility: Frederick Health-James M Stockman Cancer Center

location_facility: Hospital de Base de Sao Jose do Rio Preto

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Centro Hospitalar de Lisboa Ocidental, EPE

location_facility: The Oncology Institute of Hope & Innovation

location_facility: Hospital General Universitario Morales Meseguer

location_facility: The First Affiliated Hospital of Xiamen University

location_facility: Algemeen Ziekenhuis AZ Klina - Borstkliniek

location_facility: SBHI Arkhangelsk Region - Arkhangelsk Clinical Oncological Dispensary

location_facility: Complejo Hospitalario Universitario A Coruña (CHUA)

location_facility: Seoul National University Bundang Hospital

location_facility: MedStar Franklin Square Medical Center-Harry and Jeanette Weinberg Cancer Institute

location_facility: Wellmont Medical Associates Oncology & Hematology

location_facility: Instituto do Cancer do Estado de Sao Paulo (ICESP)

location_facility: Hospital Universitario Puerta de Hierro de Majadahonda

location_facility: Consorcio Hospitalario Provincial de Castelló

location_facility: National Hospital Organization - National Kyushu Cancer Center

location_facility: Hospital Universitario Clínico San Cecilio

location_facility: Hospital MD Anderson Cancer Center Madrid

location_facility: Colchester Hospital, East Suffolk & North Essex NHS Foundation Trust

location_facility: Frankfurt University Department of Gynecology and Obstetrics

location_facility: Istitutoperla Ricercaela Curadel Cancro IRCC

location_facility: MediOnko-Institut GbR, Praxisklinik Krebsheilkunde

location_facility: Medizinisches Versorgungszentrum für Hämatologie und Onkologie München MVZ GmbH

location_facility: Second Affiliated Hospital of Zhejiang University

location_facility: SCRI TO Nashville- Gallatin Tennessee Oncology, PLLC

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: MedStar Franklin Square Cancer Center at Loch Raven Campus

location_facility: Regional Cancer Center at Indian Path Community Hospital

location_facility: Gemeinschaftspraxis Dres. Halder / Bangerter

location_facility: Area Vasta Sud Est Sede Operativa Grosseto

location_facility: Schwarzwald - Baar Klinikum Frauenklinik

location_facility: McGill University Health Centre - Cedars Cancer Centre

location_facility: Hospital Universitario Fundación Jiménez Díaz

location_facility: National Hospital Organization (NHO) - Shikoku Cancer Center

location_facility: Instituto Nacional de Enfermedades Neoplasicas INEN

location_facility: University of Kentucky, Markey Cancer Center, Clinical Research Organization

location_facility: Koo Foundation Sun Yat-Sen Cancer Center

location_facility: Hospital General Universitario de Alicante

location_facility: Austin Hospital- Olivia Newto-John Cancer and Wellness Centre

location_facility: Istituto Naz per la Ricerca sul Cancro (IST) Genov

location_facility: National Hospital Organization - Osaka National Hospital (ONH)

location_facility: Nanjing Medical University NMU - Jiangsu Province Hospital

location_facility: Gemeinschaftspraxis Frauenärzte am Bahnhofsplatz

location_facility: Oxford University Hospitals NHS Foundation Trust

location_facility: Showa University Hospital - Breast Center

location_facility: Union Hospital of Fujian Medical University

location_facility: Unidade Local de Saúde de Matosinhos, EPE

location_facility: Frauenklinik St. Louise - St. Vincenz- Krankenhaus GmbH

location_facility: Hospital da Senhora da Oliveira, Guimarães EPE

location_facility: Istanbul Medeniyet University Medical Faculty

location_facility: Hospital Sirio-Libanes HSL - Centro de Oncologia - Brasilia

location_facility: Harzklinikum Dorothea Christiane Erxleben

location_facility: Ochsner Hematology Oncology North Shore - Covington (West Region)

location_facility: A.O.U. Citta della Salute e della Scienza di Torino

location_facility: Kindai University (Kinki University) - Faculty of Medicine (Kinki University School of Medicine (KUSM)) - Kindai University Hospital (Kinki University Hospital) - Cancer Center

location_facility: Mammazentrum HH am Krankenhaus Jerusalem

location_facility: Tohoku University Hospital (TUH) - Clinical Research, Innovation and Education Center (CRIETO)

location_facility: Policlinico S.Orsola-Malpighi SSD Oncologia Medica Addarii

location_facility: Chi Mei Medical Center CMMC - Yongkang Branch

location_facility: The 4th Hospital of Heibei Medical University

location_facility: Instituto Português de Oncologia de Lisboa Francisco Gentil, EPE

location_facility: SCRI FCS North- Gainesville Cancer Center

location_facility: Complejo Asistencial Universitario de León

location_facility: Hospital Clínico Universitario de Valencia

location_facility: State Budget Healthcare Institution of Stavropol Region

location_facility: Hospital Universitario San Pedro de Alcantara

location_facility: Sichuan University - West China Hospital

location_facility: Department of Gyencology and Obstetrics, Saarland University Hospital

location_facility: The University of Hong Kong (HKU) - Queen Mary Hospital (QMH)

location_facility: Krankenhaus St. Elisabeth und St. Barbara Halle/Saale

location_facility: Kliniken Essen-Mitte, Klinik für Senologie/ Interdisziplinäres Brustzentrum

location_facility: Hospital Clínico Universitario Virgen de la Arrixaca

location_facility: Presidio Ospedaliero di Summa - Antonio Perrino

location_facility: Medzinische Fakultät Mannheim, Universität Heidelberg

location_facility: Reading Hospital, McGlinn Cancer Institute

location_facility: Johannes Wesling Klinikum Minden, Hämatologie-Onkologie/Brustzentrum

location_facility: Fundación Instituto Valenciano de Oncologia (IVO)

location_facility: Elmhurst Memorial Hospital- Nancy W. Knowles Cancer Center

location_facility: Chongqing Medical University - The First Affiliated Hospital

location_facility: ALTHAIA, Xarxa Assistencial Universitària de Manresa F.P.

location_facility: Our Lady of the Lake Physicians Group-Medical Oncology-Woman's Pavilion

location_facility: Universitätsklinik Freiburg, Klinik für Frauenheilkunde

location_facility: Royal United Hospital Bath NHS Trust - Royal United Hospital RUH

location_facility: MSCM Cancer Center and Institute of Oncology Department of Breast Cancer and Reconstructive Surgery

location_facility: LMU Klinikum/ Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe

location_facility: National Taiwan University Hospital NTUH

location_facility: Klinikverbund Südwest Kliniken Böblingen Frauenklinik Böblingen

location_facility: National Hospital Organization - Hokkaido Cancer Center

location_facility: Tokai University Hospital - Isehara Campus

location_facility: General Hospital of Athens Alexandra Clinic

location_facility: National Cancer Center Hospital East (NCCHE) - Kashiwa Campus

location_facility: Instituto Português de Oncologia do Porto Francisco Gentil, EPE

location_facility: University General Hospital of Heraklion

location_facility: Centro di Riferimento Oncologico di Aviano - SOC Oncologia Medica e Prevenzione Oncologica

location_facility: SCRI TO Nashville- Summit Tennessee Oncology, PLLC

location_facility: SCRI TO Nashville- Lebanon Tennessee Oncology, PLLC

location_facility: SCRI TO Nashville- Skyline Tennessee Oncology, PLLC

location_facility: Hospital Clínico Universitario Lozano Blesa

location_facility: The Sel of Centre dOncologie de Gentilly

location_facility: SCRI TO Nashville- Smyrna Tennessee Oncology, PLLC

location_facility: Pamela Youde Nethersole Eastern Hospital PYNEH

location_facility: Richard A. Henson Cancer Institute Ocean Pines

location_facility: SCRI FCS North- St. Anthony's/St. Petersburg

location_facility: Institutul Oncologic Prof. Dr. Ion Chiricuta

location_facility: SCRI TO Nashville- Southern Hills Tennessee Oncology, PLLC

location_facility: SCRI TO Nashville- St. Thomas West Tennessee Oncology, PLLC

location_facility: Jilin University JLU - First Affiliated Hospital

location_facility: The Chinese University of Hong Kong (CUHK) - Prince of Wales Hospital (PWH)

location_facility: General Hospital of Patras Agios Andreas

location_facility: Hospital Civil de Guadalajara Fray Antonio Alcalde

location_facility: CHU de Quebec - Hopital du Saint-Sacrement

location_facility: Univeristy Hospitals Bristol NHS Foundation Trust

location_facility: Centro de Investigación Clinica Trujillo EIRL

location_facility: Our Lady of the Lake Physician Group-Medical Oncology

location_facility: Centre de Cancérologie du Grand Montpellier

location_facility: St.-Johannes-Hospital Dortmund, Dept. of Obstetrics/Gynecology

location_facility: Institut für Versorgungsforschung in der Onkologie

location_facility: Jewish General Hospital Segal Cancer Centre

location_facility: National Cancer Center (NCC) - Tsukiji Campus - National Cancer Center Hospital (NCCH)

location_facility: Nanchang University - The First Affiliated Hospital

location_facility: Fundação Universidade de Caxias do Sul Instituto de Pesquisas em Saúde IPS-UCS

location_facility: Japanese Foundation for Cancer Research (JFCR) - The Cancer Institute Hospital - Breast Oncology Center

location_facility: Unifrauenklinik Köln - Studienzentrum Gynäkologie

location_facility: Soon Chun Hyang Central Medical Center (SCHMC)

location_facility: Kliniken der Stadt Köln / Brustzentrum Holweide

location_facility: Dept. OB/GYN Johanna Etienne Krankenhaus

location_facility: Complejo Hospitalario Clínico Universitario de Santiago de Compostela (CHUS)

location_facility: Consultorio del Dr. Joaqun Gabriel Reinoso Toledo

location_facility: Tennessee Oncology Nashville / Sarah Cannon

location_facility: Clinica Oncologica, Ospedali Riuniti Umberto 1

location_facility: Virginia Commonwealth University Massey Cancer Center

location_facility: Universitätsklinikum Düsseldorf, Klinik für Frauenheilkunde & Geburtshilfe

location_facility: IUC AP-HP. Sorbonne Université, Hôpital Tenon

location_facility: IOB Institute Of Oncology-Hospital Quironsalud Barcelona

location_facility: SCRI TO Nashville- Hendersonville Tennessee Oncology, PLLC

location_facility: Fundacao Pio XII-Hospital de Cancer de Barretos

location_facility: Hospital Universitario HM Puerta del Sur

location_facility: Kanagawa Cancer Center Hospital - Kanagawa Cancer Center (Kanagawa Cancer Centre Research Institute)

location_facility: Hospital Universitario Fundación Alcorcón

summary: Patients with HER2-positive primary breast cancer (BC) who do not achieve complete response after appropriate neoadjuvant therapy are at higher risk of disease recurrence. More effective treatment options are needed for this patient population. This study will examine the efficacy and safety of trastuzumab deruxtecan (T-DXd) compared with trastuzumab emtansine (T-DM1) in high-risk patients with residual invasive breast cancer following neoadjuvant therapy.


title: A Phase 4, Randomized, Open-label, Multicenter Efficacy and Safety Study of Standard Dose of Radium-223 Dichloride vs. Standard Doses of Novel Anti-hormonal Therapy (NAH) in Patients With Bone Dominant Metastatic Castration Resistant Prostate Cancer (mCRPC) Progressing on/After One Line of NAH

lead_sponsor: Bayer

ipd_sharing_description:
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

location_country:
Poland
Taiwan
Hong Kong
Spain
Italy
Austria
Australia
Russian Federation
Finland
Lithuania
United Kingdom
Hungary
Korea, Republic of
France
Israel
Singapore
Turkey
Germany
Czechia

location_facility: Institut du Cancer de Montpellier - Val d'Aurelle

location_facility: Pamela Youde Nethersole Eastern Hospital

location_facility: National Medical Research Radiology Center

location_facility: Hospital Clínico Universitario de Santiago de Compostela

location_facility: Ankara Universitesi Tip Fakultesi Hastanesi

location_facility: Universitätsklinikum Carl Gustav Carus Dresden

location_facility: Izmir Tepecik Egitim ve Arastirma Hastanesi

location_facility: Institut Claudius Regaud - iUCT Oncopole

location_facility: Clalit Health Services Rabin Medical Center-Beilinson Campus

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie

location_facility: Centre Hospitalier Universitaire - Grenoble

location_facility: Tampereen yliopistollinen sairaala, keskussairaala

location_facility: Consorcio Hospitalario Provincial de Castellón

location_facility: Hospital Universitario Clinica Puerta de Hierro

location_facility: Universitätsmedizin der Johannes Gutenberg Universität Mainz

location_facility: TC Saglik Bakanligi Goztepe ProfDr Suleyman Yalcin Sehir Has

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: Ciutat Sanitària i Universitaria de la Vall d'Hebron

location_facility: IRCCS Centro di Riferimento Oncologico (CRO)

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi

location_facility: Tomsk National Research Medical Center of RAS

location_facility: Izmir Ekonomi Universitesi Medikal Point Hastanesi

location_facility: A.O. Nazionale SS Antonio e Biagio e Cesare Arrigo

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: IRCCS Istituto Europeo di Oncologia s.r.l. (IEO)

location_facility: Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi

location_facility: Marmara Uni. Tip Fakultesi Pendik Egitim ve Aras. Hastanesi

location_facility: Hadassah Hebrew University Hospital Ein Kerem

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Szpital Wojewodzki im. Mikolaja Kopernika w Koszalinie

location_facility: Institut de Cancérologie de Lorraine - Alexis Vautrin

location_facility: Institut Bergonié - Unicancer Nouvelle Aquitaine

location_facility: Seoul National University Bundang Hospital

location_facility: Clinical Oncological Dispensary of Omsk Region

location_facility: Ankara Yildirim Beyazit Universitesi Tip Fakültesi

location_facility: Samara Regional Clinical Oncology Dispensary

location_facility: Uniwersytecki Szpital Kliniczny UM we Wroclawiu

location_facility: The Hospital of Lithuanian University of Health SciencesLUHS

location_facility: Russian Oncological Scientific Center n.a. N.N. Blokhin RAMS

location_facility: Chelyabinsk Regional Oncology Dispensary

location_facility: Szpital Grochowski im. dr.med. Rafala Masztaka

location_facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz

location_facility: Centre de Lutte Contre le Cancer François Baclesse

location_facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka

location_facility: Vilnius University Hospital Santaros Klinikos

summary:
Researchers in this study want to compare how well drug radium-223 dichloride (Xofigo) and new (novel) anti-hormonal (NAH) therapy work in participants with prostate gland cancer which has spread to the bone and progressed on or after one line of NAH therapy. Meanwhile researchers want to compare the safety of radium-223 dichloride and NAH therapy. Radium-223 dichloride is known as a radioactive drug that is taken up by bones after it is injected into the body. It works by giving off a type of radioactivity that travels a very short distance and kills the tumor cells that have spread to the bone without major effects to the healthy cells. It has been approved in many countries for the treatment of patients with prostate cancer which has spread to the bone. The NAH drugs used in this study will be either abiraterone acetate (Zytiga) (plus prednisone/prednisolone) or enzalutamide (Xtandi). Both of them are standard approved medications which are used in the treatment of advanced prostate cancer.

Participants in this study will receive either Radium-223 dichloride or a NAH therapy. Radium-223 dichloride will be given as an infusion into one of the veins on Day 1 of each 4-week cycle for a total of up to 6 cycles. Oral NAH therapy will be given per the standard approved dose once daily until the disease has progressed. Participants will visit the hospital or clinic every 2 weeks for the first 6 cycles, and only on the first day of each cycle from cycle 7 and onwards. Observation for each participant will last for about 2 years in total. Blood and urine samples will be collected from the participants and participants will be asked to complete questionnaires about the well-being and the pain.


title: A Randomized Open-Label Phase III Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Subjects With Metastatic or Locally Advanced Unresectable Urothelial Cancer

summary: The primary objective of this study is to assess overall survival (OS) with sacituzumab govitecan-hziy in comparison with treatment of physician's choice (TPC) in participants with metastatic or locally advanced unresectable urothelial cancer (UC).

lead_sponsor: Gilead Sciences

location_country:
Croatia
Spain
Italy
United Kingdom
United States
Belgium
Czechia
Hong Kong
Portugal
Austria
Australia
Puerto Rico
Israel
Turkey
Singapore
Sweden
Canada
Switzerland
China
Germany
Bulgaria
Taiwan
Greece
Georgia
Ireland
Korea, Republic of
France

location_facility: Zhejiang Provincial People's Hospital - Zhaohui

location_facility: Bagcilar Medipol Mega Universite Hastanesi

location_facility: Azienda Ospedaliero Universitaria Maggiore Della Carita

location_facility: Specialized Hospital for Active Treatment of Oncological Diseases - Sofia District

location_facility: Istituto di Candiolo - Fondazione del Piemonte per l'Oncologia

location_facility: Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi

location_facility: Theagenio Anticancer Hospital of Thessaloniki

location_facility: University Cancer Specialists - Knoxville

location_facility: Universitätsklinik für Innere Medizin Graz

location_facility: Les Hôpitaux Universitaires de Strasbourg

location_facility: Azienda Ospedaliera Santa Maria di Terni

location_facility: Tel Aviv Medical Center (Ichilov Hospital)

location_facility: Karolinska Universitetssjukhuset - Solna

location_facility: Ashford Cancer Centre Research - ICON Cancer Centre Adelaide

location_facility: Pusan National University Yangsan Hospital

location_facility: Centre Hospiltalier Universitaire Brest - Hôpital Morvan

location_facility: The First Affiliated Hospital of Fujian Medical University

location_facility: Affiliated Tumor Hospital of Xinjiang Medical University

location_facility: Dorset County Hospital NHS Foundation Trust

location_facility: Chang Gung Memorial Hospital - Linkou Branch

location_facility: Southern Adelaide Local Health Network Incorporated

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Multiprofile Hospital for Active Treatment Heart and Brain EAD

location_facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology

location_facility: Istituto Oncologico Della Svizzera Italiana (IOSI)

location_facility: Regional University General Hospital of Herakleio, Crete

location_facility: The Catholic University of Korea Saint Vincent's Hospital

location_facility: Azienda Ospedaliera Universitaria Integrata Verona

location_facility: Clinical Hospital Centre "Sestre Milosrdnice"

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E

location_facility: Tianjin Medical University Cancer Institute & Hospital

location_facility: R.S. McLaughlin Durham Regional Cancer Centre

location_facility: Harold C. Simmons Comprehensive Cancer Center

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Centro Hospitalar de Lisboa Norte - Hospital de Santa Maria

location_facility: Hacettepe Universitesi Tip Fakultesi- Kanser Enstitusu

location_facility: University of Maryland School of Medicine

location_facility: Charité Universitätsmedizin Berlin - Campus Benjamin Franklin

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Cancer Hospital of the University of Chinese Academy of Sciences Zhejiang Cancer Hospital

location_facility: The First Affiliated Hospital of Wenzhou Medical University

location_facility: Universitaetsspital Zurich - Klinik fur Medizinische Onkologie und Hematologie

location_facility: T.C. Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi

location_facility: Oklahoma Cancer Specialists and Research Institute (OCSRI)

location_facility: The Catholic University of Korea Seoul Saint Mary's Hospital

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

location_facility: Istituto Tumori Bari Giovanni Paolo II - IRCCS

location_facility: Centro Hospitalar de Leiria - Hospital de Santo André

location_facility: Institut Für Versorgungsforschung in Der Onkologie

location_facility: VKV Amerikan Hastanesi Department of Oncology

location_facility: Boca Raton Clinical Research Global USA - Plantation

location_facility: Guys and Saint Thomas NHS Foundation Trust, Guy's Hospital

location_facility: The First Affiliated Hospital of Nanchang University

location_facility: University Hospitals Birmingham NHS Foundation Trust

location_facility: Oxford University Hospitals NHS Foundation Trust

location_facility: Chinese Academy of Medical Sciences Cancer Hospital

location_facility: University of Iowa Hospitals and Clinics

location_facility: Union Hospital of Fujian Medical University

location_facility: Centrum fur Hamatologie und Onkologie Bethanien

location_facility: Centro Hospitalar de Tras-os-Montes e Alto Douro

location_facility: Ospedale di Trento - Presidio Ospedaliero Santa Chiara

location_facility: Centre Hospitalier Universitaire de Nimes

location_facility: Chinese People's Liberation Army General Hospital - 301 Hospital

location_facility: Interbalkan Medical Center of Thessaloniki

location_facility: Ordensklinikum Linz GmbH Barmherzige Schwestern

location_facility: Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital

location_facility: Hospital Universitario Puerta de Hierro de Majadahonda

location_facility: Unidade Local de Saúde da Guarda - Hospital Sousa Martins

location_facility: Krankenhaus Der Barmherzigen Bruder Wien

location_facility: Hunan Cancer Hospital - Xiangya Hospital - Central South University

location_facility: Thompson Oncology Group - Knoxville Downtown

location_facility: Centre Hospitalier Universitaire de Liège

location_facility: Institut Régional du Cancer de Montpellier ICM Val d' Aurelle

location_facility: Istanbul Acibadem University Maslak Hospital

location_facility: British Columbia Cancer Agency-Vancouver Centre

location_facility: Azienda Ospedaliero-Universitaria San Luigi Gonzaga

location_facility: Centro di Riferimento Oncologico di Aviano


acronym: AMPLITUDE

title: A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC)

ipd_sharing_description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
Philippines
South Africa
Czechia
Poland
Portugal
Austria
Australia
Russian Federation
Argentina
Puerto Rico
India
Israel
Turkey
Mexico
Malaysia
Sweden
Brazil
Canada
Hungary
China
Germany
Bulgaria
Moldova, Republic of
Denmark
Taiwan
Belarus
New Zealand
Thailand
Korea, Republic of
France
Netherlands

location_facility: Instituto Português de Oncologia Francisco Gentil - Centro Regional de Oncologia de Coimbra, S.A.

location_facility: Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)

location_facility: Russian Scientific Center of Roentgenoradiology

location_facility: Sakarya University Training and Research Hospital

location_facility: Chelyabinsk Regional Clinical Center Of Oncology And Nuclear Medicine

location_facility: Fundação Faculdade de Medicina - Instituto do Cancer do Estado de São Paulo

location_facility: Southwest Hospital, The Third Military Medical University

location_facility: Irmandade Santa Casa de Misericordia de Sao Paulo

location_facility: CIONC - Centro Integrado de Oncologia de Curitiba

location_facility: Institut de Cancérologie de l'Ouest (ICO)

location_facility: The First Affiliated Hospital of NanChang University

location_facility: Netaji Subhas chandra Bose Cancer Research Institute

location_facility: Multifunctional clinical medical center 'Medical city'

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Universidade do Estado do Rio de Janeiro - UERJ

location_facility: Divisione di Oncologia - Istituto per la ricerca e cura del cancro

location_facility: Government Medical College and Super Speciality Hospital

location_facility: Municipal Non-profit enterprise 'Bukovinian clinical oncology center'

location_facility: Ministerio da Saude - Instituto Nacional do Cancer

location_facility: Przychodnia Lekarska KOMED Roman Karaszewski

location_facility: Cancer Hospital Chinese Academy of Medical Sciences

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

location_facility: Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz

location_facility: Huadong Hospital Affiliated to Fudan University

location_facility: Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz

location_facility: Russian Scientific Center of Radiology and Surgical Technologies

location_facility: Gomel Regional Clinical Oncology Dispensary

location_facility: Seoul National University Bundang Hospital

location_facility: University of Utah Huntsman Cancer Institute

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi Ic Hastaliklari Anabilim Dali Medikal Onkoloji Bd

location_facility: Municipal Institution 'Clinical Oncology Dispensary' Under Dnipropetrovsk Regional Council

location_facility: Communal Noncommercial Enterprise of Lviv Regional Council 'Lviv Regional Clinical Hospital'

location_facility: Greater Los Angeles VA Healthcare System

location_facility: The Fifth People's Hospital of Shanghai, Fudan University

location_facility: Specjalistyczna przychodnia lekarska POLIMED

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Beijing Friendship Hospital, Capital Medical University

location_facility: Royal Cornwall Hospitals NHS Trust - Royal Cornwall Hospital

location_facility: Bursa Yuksek lhtisas EAH Medikal Onkoloji Klinigi

location_facility: State Institution National Cancer Institute

location_facility: Associacao de Combate ao Cancer em Goias - Hospital de Cancer Araujo Jorge

location_facility: UPCO Unidade de Pesquisa Clinica em Oncologia

location_facility: Eastern Connecticut Hematology & Oncology Assoc.

location_facility: Országos Onkológiai Intézet, C Belgyógyászati-Onkológiai és Klinikai Farmakológiai Osztály

location_facility: Specialized Hospital for Active Treatment in Oncology

location_facility: The First Affiliated Hospital of Xi'an Jiaotong University

location_facility: Consultorio de Especialidad en Urologia Privado

location_facility: Ce 'Dnipropetrovsk Regional Clinical Hospital N.A. Mechnikov' of Dnipropetrovsk Rc

location_facility: Sociedade Beneficente de Senhoras - Hospital Sírio Libanês

location_facility: Marie Curie Research Wing - Mount Vernon Hospital

location_facility: Ruijin Hospital Affiliated to Medical College of Shanghai Jiaotong University

location_facility: Gangnam Severance Hospital, Yonsei University Health System

location_facility: British Columbia Cancer Agency - Vancouver Island Centre

location_facility: Communal Nonprofit Enterprise 'Cherkasy Regional Oncology Dispensary Of Cherkasy Regional Council'

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Guangzhou First Municipal People's Hospital

location_facility: Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi

location_facility: Western Theater General Hospital of the Chinese People's Liberation Army

location_facility: The First Affliated Hospital of Soochow University

location_facility: Universitätsklinik Carl Gustav Carus, Med. Klinik u. Poliklinik I

location_facility: Centre Hospitalier de l'Universite de Montreal

location_facility: Renji Hospital Affiliated to Medical College of Shanghai Jiaotong University

location_facility: Istituti Ospitalieri di Cremona, AO di Cremona

location_facility: Kingston Health Sciences Centre, Kingston General Health Research Institute

location_facility: Centre de radiothérapie et d'Oncologie médicale de l'Essonne

location_facility: Ralph H. Johnson Veterans Affairs Medical Center

location_facility: Real e Benemérita Associação Portuguesa de Beneficência

location_facility: Cemaic - Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica

location_facility: Communal Institution 'City hospital №7 of Kamianske' of Dnepropetrov'sk Regional Council

location_facility: CINME - Centro de Investigaciones Metabolicas

location_facility: Istituto Oncologico Veneto Iov Irccs Padova

location_facility: Urologica Praktyka Lekarska Adam Marcheluk

location_facility: PERSONAL - Oncologia de Precisão e Personalizada

location_facility: District Oncology Dispensary with In-Patient Stationary - Plovdiv

location_facility: Centro de Investigación Clínica Gramel S.C.

location_facility: British Columbia Cancer Agency (BCCA) - Vancouver Centre

location_facility: Rabin Medical Center, Beilinson Hospital

location_facility: University College London Hospitals NHSFT

location_facility: Fundacao do ABC - Centro Universitario FMABC

location_facility: Szpital Grochowski im. dr med. Rafała Masztaka Sp. z o.o.

location_facility: IOS - Instituto de Oncologia de Sorocaba Dr. Gilson Delgado

location_facility: Urological Associates of Southern Arizona, P.C.

location_facility: State Institution N.N. Alexandrov Republican Scientific and

location_facility: Communal Institution 'Regional Oncology Dispensary' of Zhytomyr Region Council

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

location_facility: Fondazione G. Pascale - Istituto Nazionale Tumori IRCCS

location_facility: Szpital Uniwersytecki NR 1 IM. Dr. Antoniego Jurasza

location_facility: Bhagwan Mahaveer Hospital & Research Centre

location_facility: The First Affiliated Hospital of Wenzhou Medical University

location_facility: Klinikum rechts der Isar - III. Med. Klinik und Poliklinik

location_facility: Centre Hopitalier Inter-Communal De Cornouaille

location_facility: Städtisches Klinikum Braunschweig gGmbH - Standort Salzdahlumer

location_facility: Multifunctional Hospital for Active Treatment for Women Health Nadezhda

location_facility: Istanbul University Istanbul Medical Faculty

location_facility: Centro de Pesquisa e Ensino em Oncologia de Santa Catarina - CEPEN

location_facility: Instituto de Assistencia Medica ao Servidor Publico Estadual - IAMSPE

location_facility: McGill University - Jewish General Hospital

location_facility: British Columbia Cancer Agency(BCCA)-Sindi Ahluwalia Hawkins Centre for the Southern Interior(CSI)

location_facility: Post Graduate Institute of Medical Education & Research (PGIMER)

location_facility: Bobruisk Interregional Oncological Dispensary

location_facility: Instituto Joinvilense de Hematologia e Oncologia Ltda - Centro de Hematologia e Oncologia

location_facility: Chang-Gung Memorial Hospital, LinKou Branch

location_facility: Dnipropetrovsk State Medical Academy, Dnipropetrovsk City Multifield Clinical Hospital # 4

location_facility: University Health Network (UHN) Princess Margaret Cancer Centre

location_facility: Institut Kanser Negara - Clinical Research Center

location_facility: Dr.Abdurrahman Yurtaslan Oncology Training and Research Hospital

location_facility: University of California Irvine Medical Center - Chao Family Comprehensive Cancer Center

location_facility: Grand Hôpital de Charleroi, site Notre Dame

location_facility: Centrum Onkologii im. Prof. F. Lukaszczyka

location_facility: University of Pittsburgh Medical Center (UPMC)

location_facility: TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology

location_facility: Institut Regional du Cancer de Montpellier Val d'Aurelle

location_facility: Municipal non-profit enterprise 'Regional Center of Oncology'

location_facility: Kyungpook National University Chilgok Hospital

location_facility: The Catholic University of Korea, Seoul St. Mary's Hospital

location_facility: Minsk city Clinical Oncological Dispensary

location_facility: Private Medical Institution Euromedservice

location_facility: Queens Cancer Center of Queens Hospital Center

location_facility: Shengjing Hospital of China Medical University

location_facility: Second Affiliated Hospital of Soochow University

location_facility: University of Mississippi Medical Center

location_facility: Virginia Commonwealth University - Massey Cancer Center

location_facility: Jahn Ferenc Del-pesti Korhaz es Rendelointezet

location_facility: West China Hospital of Sichuan University

location_facility: Regional Medical Clinical Center for Urology and Nephrology named after V.I. Shapoval

location_facility: Instituto de Ensino e Pesquisa São Lucas

location_facility: State Institution Institute of Urology NAMS of Ukraine based on Kyiv City Clinical Oncology Center

location_facility: ASL Napoli 2 Nord-SM delle Grazie Hospital

location_facility: T.C. Saglik Bakanlıgi Goztepe Prof. Dr. Suleyman Yalcın Sehir Hastanesi

location_facility: Brighton and Sussex University Hospitals NHS Trust

location_facility: Irmandade Santa Casa de Misericordia de Porto Alegre

location_facility: Instituto do Cancer Arnaldo Vieira de Carvalho

location_facility: Ivano-Frankivsk Regional Clinical Hospital

summary: The purpose of the study is to determine if the combination of niraparib with Abiraterone Acetate (AA) plus prednisone compared with AA plus prednisone in participants with deleterious germline or somatic Homologous Recombination Repair (HRR) gene-mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC) provides superior efficacy in improving radiographic progression-free survival (rPFS).