title: SYNTAX Study: SYNergy Between PCI With TAXUS and Cardiac Surgery

acronym: SYNTAX

summary: The SYNTAX trial is designed to determine the best treatment for patients with complex coronary disease (blocked or narrowed arteries in both the right and left sides of the heart) by randomizing patients to receive either percutaneous coronary intervention (PCI) with polymer-based paclitaxel-eluting TAXUS stents or to coronary artery bypass surgery (CABG).

status: Unknown status

study_completion_date_type: Anticipated

ReferenceCitation: Hara H, Kawashima H, Ono M, Takahashi K, Mack MJ, Holmes DR Jr, Morice MC, Davierwala PM, Mohr FW, Thuijs DJFM, Kappetein AP, O'Leary N, van Klaveren D, Onuma Y, Serruys PW. Impact of preprocedural biological markers on 10-year mortality in the SYNTAXES trial. EuroIntervention. 2021 Oct 21. pii: EIJ-D-21-00415. doi: 10.4244/EIJ-D-21-00415. [Epub ahead of print]

ReferenceCitation: Thuijs DJFM, Davierwala P, Milojevic M, Deo SV, Noack T, Kappetein AP, Serruys PW, Mohr FW, Morice MC, Mack MJ, Ståhle LEGE, Verberkmoes NJ, Holmes DR, Head SJ; SYNTAX Extended Survival Investigators. Long-term survival after coronary bypass surgery with multiple versus single arterial grafts. Eur J Cardiothorac Surg. 2021 Oct 7. pii: ezab392. doi: 10.1093/ejcts/ezab392. [Epub ahead of print]

name: Department of Cardiothoracic Surgery, Erasmus University Medical Centre, Rotterdam, Netherlands

family: Thuijs

full_name: Daniel J F M Thuijs

given: Daniel J F M

name: University Department of Cardiac Surgery, Heart Centre Leipzig, Leipzig, Germany

name: Division of Cardiovascular Surgery, Peter Munk Cardiac Centre, Toronto General Hospital, 15 University Health Network, Toronto, Ontario, Canada

name: Department of Surgery, University of Toronto, Toronto, Canada

family: Davierwala

full_name: Piroze Davierwala

given: Piroze

name: Department of Cardiac Surgery and Cardiovascular Research, Dedinje Cardiovascular Institute, Belgrade, Serbia

family: Milojevic

full_name: Milan Milojevic

given: Milan

name: Department of Cardiovascular Surgery, Louis Stokes Cleveland VA Medical Center, Cleveland, OH, USA

family: Deo

full_name: Salil V Deo

given: Salil V

family: Noack

full_name: Thilo Noack

given: Thilo

family: Kappetein

full_name: A Pieter Kappetein

given: A Pieter

name: Department of Cardiology, National University of Ireland, Galway, Ireland

family: Serruys

full_name: Patrick W Serruys

given: Patrick W

family: Mohr

full_name: Friedrich-Wilhelm Mohr

given: Friedrich-Wilhelm

name: Department of Cardiology, Cardiovascular Institute Paris-Sud (ICPS), Hopital privé Jacques Cartier, Ramsay, Générale de Santé Massy, France

family: Morice

full_name: Marie-Claude Morice

given: Marie-Claude

name: Department of Cardiothoracic Surgery, Baylor University Medical Center, Dallas, TX, USA

family: Mack

full_name: Michael J Mack

given: Michael J

name: Department of Thoracic and Cardiovascular Surgery, University Hospital, Uppsala, Sweden

family: Ståhle

full_name: L Elisabeth G E Ståhle

given: L Elisabeth G E

name: Department of Cardiothoracic Surgery, Catharina Hospital, Eindhoven, Netherlands

family: Verberkmoes

full_name: Niels J Verberkmoes

given: Niels J

name: Department of Cardiovascular Diseases and Internal Medicine, Mayo Clinic, Rochester, MN, USA

family: Holmes

full_name: David R Holmes

given: David R

suffix: Jr

family: Head

full_name: Stuart J Head

given: Stuart J

name: for the SYNTAX Extended Survival Investigators

journal_name: European Journal of Cardio-Thoracic Surgery

publisher_normalized: Oxford University Press

title: Long-term survival after coronary bypass surgery with multiple versus single arterial grafts

ReferenceCitation: Wang R, Garg S, Gao C, Kawashima H, Ono M, Hara H, van Geuns RJ, Morice MC, Davierwala PM, Kappetein AP, Holmes DR, Wijns W, Tao L, Onuma Y, Serruys PW. Impact of established cardiovascular disease on 10-year death after coronary revascularization for complex coronary artery disease. Clin Res Cardiol. 2021 Oct;110(10):1680-1691. doi: 10.1007/s00392-021-01922-y. Epub 2021 Aug 25.

family: Wang

full_name: Rutao Wang

given: Rutao

family: Garg

full_name: Scot Garg

given: Scot

family: Gao

full_name: Chao Gao

given: Chao

family: Kawashima

full_name: Hideyuki Kawashima

given: Hideyuki

family: Ono

full_name: Masafumi Ono

title: Impact of established cardiovascular disease on 10-year death after coronary revascularization for complex coronary artery disease

ReferenceCitation: Davierwala PM, Gao C, Thuijs DJFM, Wang R, Hara H, Ono M, Noack T, Garg S, O'leary N, Milojevic M, Kappetein AP, Morice MC, Mack MJ, van Geuns RJ, Holmes DR, Gaudino M, Taggart DP, Onuma Y, Mohr FW, Serruys PW; SYNTAX Extended Survival Investigators. Single or multiple arterial bypass graft surgery vs. percutaneous coronary intervention in patients with three-vessel or left main coronary artery disease. Eur Heart J. 2021 Aug 18. pii: ehab537. doi: 10.1093/eurheartj/ehab537. [Epub ahead of print]

name: Division of Cardiovascular Surgery, Peter Munk Cardiac Centre, Toronto General Hospital, University Health Network, 200 Elizabeth St, Toronto, ON M5G 2C4, Canada

name: Department of Cardiology, Xijing Hospital, Changle West Road, Xi'an 710032, China

name: Department of Cardiology, Radboud University, Geert Grooteplein Zuid 10, Nijmegen 6525 GA, The Netherlands

name: Department of Cardiology, National University of Ireland, Galway (NUIG), University Road, Galway H91 TK33, Ireland

name: Department of Cardiothoracic Surgery, Erasmus University Medical Centre, Doctor Molewaterplein 40, Rotterdam 3015 GD, the Netherlands

name: Department of Cardiology, Academic Medical Center, University of Amsterdam, Meibergdreef 9, Amsterdam 1105 AZ, the Netherlands

name: University Department of Cardiac Surgery, Heart Centre Leipzig, Strümpellstraße 39, Leipzig 04289, Germany

name: Department of Cardiology, Royal Blackburn Hospital, Haslingden Rd, Blackburn BB2 3HH, UK

name: Department of Cardiology, Cardiovascular Institute Paris-Sud (ICPS), Hopital privé Jacques Cartier, Ramsay, Générale de Santé Massy, 6 Av. du Noyer Lambert, 91300 Massy, France

name: Department of Cardiothoracic Surgery, Baylor University Medical Center, 3500 Gaston Ave, Dallas, TX 75246, USA

name: Department of Cardiovascular Diseases and Internal Medicine, Mayo Clinic, 1216 2nd St SW, Rochester, MN 55902, USA

name: Department of Cardiothoracic Surgery, Weill Cornell Medicine, 1300 York Ave, New York, NY 10065, USA

name: Department of Cardiovascular Surgery, University of Oxford, Headley Way, Headington, Oxford OX3 9DU, UK

title: Single or multiple arterial bypass graft surgery vs. percutaneous coronary intervention in patients with three-vessel or left main coronary artery disease

ReferenceCitation: Wang R, Serruys PW, Gao C, Hara H, Takahashi K, Ono M, Kawashima H, O'leary N, Holmes DR, Witkowski A, Curzen N, Burzotta F, James S, van Geuns RJ, Kappetein AP, Morel MA, Head SJ, Thuijs DJFM, Davierwala PM, O'Brien T, Fuster V, Garg S, Onuma Y. Ten-year all-cause death after percutaneous or surgical revascularization in diabetic patients with complex coronary artery disease. Eur Heart J. 2021 Aug 18. pii: ehab441. doi: 10.1093/eurheartj/ehab441. [Epub ahead of print]

name: Department of Cardiology, Xijing Hospital, Changle West Road 127, Xi’an 710032, China

name: Department of Cardiology, Radboud University Medical Center, Geert Grooteplein Zuid 8, 6525 GA Nijmegen, The Netherlands

name: Department of Cardiology, Imperial College London, Exhibition Rd, London SW7 2BX, UK

name: Department of Cardiology, Academic Medical Center, University of Amsterdam, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands

name: Department of Cardiology, Mayo ClinicSchool of Medicine, 200 First St. SW Rochester, MN 55905, USA

name: Department of Interventional Cardiology and Angiology, National Institute of Cardiology, ul. Alpejska 42, 04-628 Warsaw, Poland

name: Cardiology Department, University Hospital Southampton, Coxford Rd, Southampton SO16 5YA, UK

name: Institute of Cardiology, Catholic University of the Sacred Heart, Largo F. Vito 1, Rome 00168, Italy

name: Department of Medical Sciences, Cardiology and Uppsala Clinical Research Center, Uppsala University, Dag Hammarskjolds vag 14B SE-752 37, Uppsala, Sweden

name: Department of Cardiothoracic Surgery, Erasmus University Medical Centre, Dr Molewaterplein 40, 3015 GE Rotterdam, The Netherlands

name: Department of Cardiac Surgery, Heart Centre Leipzig, Strumpelstrasse 39, Leipzig 4289, Germany

name: Regenerative Medicine Institute, CURAM, National University of Ireland, Galway (NUIG), University Road, Galway H91 TK33, Ireland

name: Division of Cardiology, Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicina at Mount Sinai School, 1 Gustave L. Levy Place, 10029-5674 New York, NY, USA

name: Department of Cardiology, East Lancashire Hospitals NHS Trust, Haslingden Rd, Blackburn BB2 3HH, Lancashire, UK

repository_institution: University of Southampton - ePrints Soton

repositories_institution: University of Southampton - ePrints Soton

title: Ten-year all-cause death after percutaneous or surgical revascularization in diabetic patients with complex coronary artery disease

ReferenceCitation: Ono M, Kawashima H, Hara H, Mancone M, Mack MJ, Holmes DR, Morice MC, Kappetein AP, Thuijs DJFM, Noack T, Mohr FW, Davierwala PM, Onuma Y, Serruys PW; SYNTAX Extended Survival Investigators. Impact of major infections on 10-year mortality after revascularization in patients with complex coronary artery disease. Int J Cardiol. 2021 Oct 15;341:9-12. doi: 10.1016/j.ijcard.2021.08.013. Epub 2021 Aug 8.

title: Impact of major infections on 10-year mortality after revascularization in patients with complex coronary artery disease

ReferenceCitation: Kawashima H, Serruys PW, Ono M, Hara H, O'Leary N, Mack MJ, Holmes DR, Morice MC, Head SJ, Kappetein AP, Thuijs DJFM, Milojevic M, Noack T, Mohr FW, Davierwala PM, Sharif F, McEvoy JW, Onuma Y; SYNTAX Extended Survival Investigators. Impact of Optimal Medical Therapy on 10-Year Mortality After Coronary Revascularization. J Am Coll Cardiol. 2021 Jul 6;78(1):27-38. doi: 10.1016/j.jacc.2021.04.087.

journal_name: Journal of the American College of Cardiology

title: Impact of Optimal Medical Therapy on 10-Year Mortality After Coronary Revascularization

ReferenceCitation: Ono M, Serruys PW, Hara H, Kawashima H, Gao C, Wang R, Takahashi K, O'Leary N, Wykrzykowska JJ, Sharif F, Piek JJ, Garg S, Mack MJ, Holmes DR, Morice MC, Head SJ, Kappetein AP, Thuijs DJFM, Noack T, Davierwala PM, Mohr FW, Cohen DJ, Onuma Y; SYNTAX Extended Survival Investigators. 10-Year Follow-Up After Revascularization in Elderly Patients With Complex Coronary Artery Disease. J Am Coll Cardiol. 2021 Jun 8;77(22):2761-2773. doi: 10.1016/j.jacc.2021.04.016.

title: 10-Year Follow-Up After Revascularization in Elderly Patients With Complex Coronary Artery Disease

ReferenceCitation: Ono M, Kawashima H, Hara H, O'Leary N, Gao C, Wang R, Takahashi K, Wykrzykowska JJ, Piek JJ, Mack MJ, Holmes DR, Morice MC, Head SJ, Kappetein AP, Thuijs DJFM, Noack T, Friedrich MW, Davierwala PM, McEvoy JW, Onuma Y, Serruys PW. Impact of Body Composition Indices on Ten-year Mortality After Revascularization of Complex Coronary Artery Disease (From the Syntax Extended Survival Trial). Am J Cardiol. 2021 Jul 15;151:30-38. doi: 10.1016/j.amjcard.2021.04.008. Epub 2021 May 26.

title: Impact of Body Composition Indices on Ten-year Mortality After Revascularization of Complex Coronary Artery Disease (From the Syntax Extended Survival Trial)

ReferenceCitation: Takahashi K, Serruys PW, Gao C, Ono M, Wang R, Thuijs DJFM, Mack MJ, Curzen N, Mohr FW, Davierwala P, Milojevic M, Wykrzykowska JJ, de Winter RJ, Sharif F, Onuma Y, Head SJ, Kappetein AP, Morice MC, Holmes DR Jr; SYNTAX Extended Survival Study Investigators. Ten-Year All-Cause Death According to Completeness of Revascularization in Patients With Three-Vessel Disease or Left Main Coronary Artery Disease: Insights From the SYNTAX Extended Survival Study. Circulation. 2021 Jul 13;144(2):96-109. doi: 10.1161/CIRCULATIONAHA.120.046289. Epub 2021 May 20.

name: Department of Cardiology, Amsterdam University Medical Center, University of Amsterdam, The Netherlands (K.T., M.O., J.J.W., R.J.d.W.).

name: Department of Cardiology, National University of Ireland, Galway (NUIG), Ireland (P.W.S., Y.O.).

name: Department of Cardiology, Radboudumc, Nijmegen, The Netherlands (C.G., R.W.).

name: Department of Cardiothoracic Surgery, Erasmus University Medical Centre, Rotterdam, The Netherlands (D.J.F.M.T., M.M., S.J.H., A.P.K.).

name: Department of Cardiothoracic Surgery, Baylor Scott & White Health, Dallas, TX (M.J.M.).

name: Department of Cardiology, University Hospital Southampton NHS FT, UK (N.C.).

name: University Department of Cardiac Surgery, Heart Centre Leipzig, Germany (F.-W.M., P.D.).

name: Now with Division of Cardiovascular Surgery, Peter Munk Cardiac Centre, Toronto General Hospital, University Health Network, Ontario, Canada (P.D.).

name: Department of Cardiothoracic Surgery, Dedinje Cardiovascular Institute, Belgrade, Serbia (M.M.).

name: Department of Cardiology, University Medical Centre Groningen, University of Groningen, The Netherlands (J.J.W.).

name: CURAM, Cardiovascular Research and Innovation Centre (CVRI), BioInnovate Ireland, Department of Cardiology, Galway University Hospital and National University of Ireland, Ireland (F.S.).

name: Département of Cardiologie, Hôpital privé Jacques Cartier, Générale de Santé Massy, France (M.-C.M.).

name: Department of Cardiovascular Diseases and Internal Medicine, Mayo Clinic, Rochester, MN (D.R.H.).

name: on behalf of the SYNTAX Extended Survival Study Investigators

ReferenceCitation: Wang R, Tomaniak M, Takahashi K, Gao C, Kawashima H, Hara H, Ono M, van Klaveren D, van Geuns RJ, Morice MC, Davierwala PM, Mack MJ, Witkowski A, Curzen N, Berti S, Burzotta F, James S, Kappetein AP, Head SJ, Thuijs DJFM, Mohr FW, Holmes DR, Tao L, Onuma Y, Serruys PW. Impact of chronic obstructive pulmonary disease on 10-year mortality after percutaneous coronary intervention and bypass surgery for complex coronary artery disease: insights from the SYNTAX Extended Survival study. Clin Res Cardiol. 2021 Jul;110(7):1083-1095. doi: 10.1007/s00392-021-01833-y. Epub 2021 Mar 12.

repository_institution: Uppsala University - Uppsala University Publications

repositories_institution: Uppsala University - Uppsala University Publications

ReferenceCitation: Takahashi K, Thuijs DJFM, Gao C, Ono M, Holmes DR, Mack MJ, Morice MC, Mohr FW, Curzen N, Davierwala PM, Milojevic M, Dawkins KD, Wykrzykowska JJ, de Winter RJ, McEvoy JW, Onuma Y, Head SJ, Kappetein AP, Serruys PW. Ten-year all-cause mortality according to smoking status in patients with severe coronary artery disease undergoing surgical or percutaneous revascularization. Eur J Prev Cardiol. 2020 Nov 30. pii: zwaa089. doi: 10.1093/eurjpc/zwaa089. [Epub ahead of print]

name: Department of Cardiology, Amsterdam Universities Medical Centers, Location Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands

name: Department of Cardiothoracic Surgery, Erasmus University Medical Centre, Rotterdam, The Netherlands

name: Department of Cardiology, Radboud Medical Center, Nijmegen, The Netherlands

name: Department of Cardiothoracic Surgery, Baylor Scott & White Health, Dallas, TX, USA

name: Département of Cardiologie, Hôpital privé Jacques Cartier, Générale de Santé Massy, Paris, France

name: Department of Cardiology, Coronary Research Group, University Hospital Southampton NHS FT, Southampton, UK

name: Shockwave Medical Inc, 5403 Betsy Ross Dr Santa Clara, CA 95054, Santa Clara, CA, USA

name: Department of Cardiology, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands

name: Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland

journal_name: European Journal of Preventive Cardiology

title: Ten-year all-cause mortality according to smoking status in patients with severe coronary artery disease undergoing surgical or percutaneous revascularization

ReferenceCitation: Kawashima H, Takahashi K, Ono M, Hara H, Wang R, Gao C, Sharif F, Mack MJ, Holmes DR, Morice MC, Head SJ, Kappetein AP, Thuijs DJFM, Milojevic M, Noack T, Mohr FW, Davierwala PM, Serruys PW, Onuma Y; SYNTAX Extended Survival Investigators. Mortality 10 Years After Percutaneous or Surgical Revascularization in Patients With Total Coronary Artery Occlusions. J Am Coll Cardiol. 2021 Feb 9;77(5):529-540. doi: 10.1016/j.jacc.2020.11.055.

title: Mortality 10 Years After Percutaneous or Surgical Revascularization in Patients With Total Coronary Artery Occlusions

ReferenceCitation: Wang R, Takahashi K, Garg S, Thuijs DJFM, Kappetein AP, Mack MJ, Morice MC, Mohr FW, Curzen N, Davierwala P, Milojevic M, van Geuns RJ, Head SJ, Onuma Y, Holmes DR Jr, Serruys PW. Ten-year all-cause death following percutaneous or surgical revascularization in patients with prior cerebrovascular disease: insights from the SYNTAX Extended Survival study. Clin Res Cardiol. 2021 Oct;110(10):1543-1553. doi: 10.1007/s00392-020-01802-x. Epub 2021 Jan 30.

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

repositories_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

title: Ten-year all-cause death following percutaneous or surgical revascularization in patients with prior cerebrovascular disease: insights from the SYNTAX Extended Survival study

ReferenceCitation: Hara H, Serruys PW, Takahashi K, Kawashima H, Ono M, Gao C, Wang R, Mohr FW, Holmes DR, Davierwala PM, Head SJ, Thuijs DJFM, Milojevic M, Kappetein AP, Garg S, Onuma Y, Mack MJ; SYNTAX Extended Survival Investigators. Impact of Peri-Procedural Myocardial Infarction on Outcomes After Revascularization. J Am Coll Cardiol. 2020 Oct 6;76(14):1622-1639. doi: 10.1016/j.jacc.2020.08.009.

title: Impact of Peri-Procedural Myocardial Infarction on Outcomes After Revascularization

ReferenceCitation: Hara H, Takahashi K, van Klaveren D, Wang R, Garg S, Ono M, Kawashima H, Gao C, Mack M, Holmes DR, Morice MC, Head SJ, Kappetein AP, Thuijs DJFM, Onuma Y, Noack T, Mohr FW, Davierwala PM, Serruys PW; SYNTAX Extended Survival Investigators. Sex Differences in All-Cause Mortality in the Decade Following Complex Coronary Revascularization. J Am Coll Cardiol. 2020 Aug 25;76(8):889-899. doi: 10.1016/j.jacc.2020.06.066.

title: Sex Differences in All-Cause Mortality in the Decade Following Complex Coronary Revascularization

ReferenceCitation: Modolo R, Chichareon P, Kogame N, Dressler O, Crowley A, Ben-Yehuda O, Puskas J, Banning A, Taggart DP, Kappetein AP, Sabik JA, Onuma Y, Stone GW, Serruys PW. Contemporary Outcomes Following Coronary Artery Bypass Graft Surgery for Left Main Disease. J Am Coll Cardiol. 2019 Apr 23;73(15):1877-1886. doi: 10.1016/j.jacc.2018.12.090.

repository_institution: University of Oxford - Oxford University Research Archive (ORA)

repositories_institution: University of Oxford - Oxford University Research Archive (ORA)

title: Contemporary Outcomes Following Coronary Artery Bypass Graft Surgery for Left Main Disease

ReferenceCitation: Milojevic M, Head SJ, Mack MJ, Mohr FW, Morice MC, Dawkins KD, Holmes DR Jr, Serruys PW, Kappetein AP. Influence of practice patterns on outcome among countries enrolled in the SYNTAX trial: 5-year results between percutaneous coronary intervention and coronary artery bypass grafting. Eur J Cardiothorac Surg. 2017 Sep 1;52(3):445-453. doi: 10.1093/ejcts/ezx104.

title: Influence of practice patterns on outcome among countries enrolled in the SYNTAX trial: 5-year results between percutaneous coronary intervention and coronary artery bypass grafting†

ReferenceCitation: Sotomi Y, Onuma Y, Cavalcante R, Ahn JM, Lee CW, van Klaveren D, de Winter RJ, Wykrzykowska JJ, Farooq V, Morice MC, Steyerberg EW, Park SJ, Serruys PW. Geographical Difference of the Interaction of Sex With Treatment Strategy in Patients With Multivessel Disease and Left Main Disease: A Meta-Analysis From SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery), PRECOMBAT (Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease), and BEST (Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients With Multivessel Coronary Artery Disease) Randomized Controlled Trials. Circ Cardiovasc Interv. 2017 May;10(5). pii: e005027. doi: 10.1161/CIRCINTERVENTIONS.117.005027.

name: From the Academic Medical Center, University of Amsterdam, the Netherlands (Y.S., R.J.d.W., J.J.W.); ThoraxCenter, Erasmus Medical Center, Rotterdam, the Netherlands (Y.O., R.C.); Heart Institute, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea (J.-M.A., C.W.L., S.-J.P.); Department of Public Health, Erasmus Medical Centre, Rotterdam, the Netherlands (D.v.K., E.W.S.); Institute of Cardiovascular Sciences, Manchester Academic Health Sciences Centre, University of...

title: Geographical Difference of the Interaction of Sex With Treatment Strategy in Patients With Multivessel Disease and Left Main Disease

ReferenceCitation: Abdallah MS, Wang K, Magnuson EA, Osnabrugge RL, Kappetein AP, Morice MC, Mohr FA, Serruys PW, Cohen DJ; SYNTAX Trial Investigators. Quality of Life After Surgery or DES in Patients With 3-Vessel or Left Main Disease. J Am Coll Cardiol. 2017 Apr 25;69(16):2039-2050. doi: 10.1016/j.jacc.2017.02.031.

title: Quality of Life After Surgery or DES in Patients With 3-Vessel or Left Main Disease

ReferenceCitation: Cavalcante R, Sotomi Y, Zeng Y, Lee CW, Ahn JM, Collet C, Tenekecioglu E, Suwannasom P, Onuma Y, Park SJ, Serruys PW. Coronary bypass surgery versus stenting in multivessel disease involving the proximal left anterior descending coronary artery. Heart. 2017 Mar;103(6):428-433. doi: 10.1136/heartjnl-2016-309720. Epub 2016 Sep 20.

title: Coronary bypass surgery versus stenting in multivessel disease involving the proximal left anterior descending coronary artery

ReferenceCitation: Migliorini A, Valenti R, Parodi G, Vergara R, Buonamici P, Cerisano G, Carrabba N, Antoniucci D. Angiographic and Clinical Outcomes After Everolimus-Eluting Stenting for Unprotected Left Main Disease and High Anatomic Coronary Complexity. JACC Cardiovasc Interv. 2016 May 23;9(10):1001-7. doi: 10.1016/j.jcin.2016.02.016.

title: Angiographic and Clinical Outcomes After Everolimus-Eluting Stenting for Unprotected Left Main Disease and High Anatomic Coronary Complexity

ReferenceCitation: Milojevic M, Head SJ, Parasca CA, Serruys PW, Mohr FW, Morice MC, Mack MJ, Ståhle E, Feldman TE, Dawkins KD, Colombo A, Kappetein AP, Holmes DR Jr. Causes of Death Following PCI Versus CABG in Complex CAD: 5-Year Follow-Up of SYNTAX. J Am Coll Cardiol. 2016 Jan 5;67(1):42-55. doi: 10.1016/j.jacc.2015.10.043.

title: Causes of Death Following PCI Versus CABG in Complex CAD

ReferenceCitation: Osnabrugge RL, Magnuson EA, Serruys PW, Campos CM, Wang K, van Klaveren D, Farooq V, Abdallah MS, Li H, Vilain KA, Steyerberg EW, Morice MC, Dawkins KD, Mohr FW, Kappetein AP, Cohen DJ; SYNTAX trial investigators. Cost-effectiveness of percutaneous coronary intervention versus bypass surgery from a Dutch perspective. Heart. 2015 Dec;101(24):1980-8. doi: 10.1136/heartjnl-2015-307578. Epub 2015 Nov 9.

title: Cost-effectiveness of percutaneous coronary intervention versus bypass surgery from a Dutch perspective

ReferenceCitation: Parasca CA, Head SJ, Mohr FW, Mack MJ, Morice MC, Holmes DR Jr, Feldman TE, Colombo A, Dawkins KD, Serruys PW, Kappetein AP; SYNTAX Investigators. The impact of a second arterial graft on 5-year outcomes after coronary artery bypass grafting in the Synergy Between Percutaneous Coronary Intervention With TAXUS and Cardiac Surgery Trial and Registry. J Thorac Cardiovasc Surg. 2015 Sep;150(3):597-606.e2. doi: 10.1016/j.jtcvs.2015.05.010. Epub 2015 May 8.

journal_name: The Journal of Thoracic and Cardiovascular Surgery

ReferenceCitation: Iqbal J, Zhang YJ, Holmes DR, Morice MC, Mack MJ, Kappetein AP, Feldman T, Stahle E, Escaned J, Banning AP, Gunn JP, Colombo A, Steyerberg EW, Mohr FW, Serruys PW. Optimal medical therapy improves clinical outcomes in patients undergoing revascularization with percutaneous coronary intervention or coronary artery bypass grafting: insights from the Synergy Between Percutaneous Coronary Intervention with TAXUS and Cardiac Surgery (SYNTAX) trial at the 5-year follow-up. Circulation. 2015 Apr 7;131(14):1269-77. doi: 10.1161/CIRCULATIONAHA.114.013042. Epub 2015 Feb 24.

name: From the Thoraxcenter (J.I., Y.-J.Z., A.P.K., P.W.S.) and Department of Public Health (E.W.S.), Erasmus Medical Centre, Rotterdam, The Netherlands; University of Sheffield, UK (J.I., J.P.G.); Mayo Clinic, Rochester, MN (D.R.H.); ICPS, Hopital privé Jacques Cartier, Générale de Santé Massy, France (M.-C.M.); The Heart Hospital, Dallas, TX (M.J.M.); Evanston Hospital, IL (T.F.); University Hospital Uppsala, Sweden (E.S.); Hospital Clínico San Carlos, Madrid, Spain (J.E.); Oxford University Hospitals,...

title: Optimal Medical Therapy Improves Clinical Outcomes in Patients Undergoing Revascularization With Percutaneous Coronary Intervention or Coronary Artery Bypass Grafting

ReferenceCitation: Campos CM, Costa F, Garcia-Garcia HM, Bourantas C, Suwannasom P, Valgimigli M, Morel MA, Windecker S, Serruys PW. Anatomic characteristics and clinical implications of angiographic coronary thrombus: insights from a patient-level pooled analysis of SYNTAX, RESOLUTE, and LEADERS Trials. Circ Cardiovasc Interv. 2015 Apr;8(4). pii: e002279. doi: 10.1161/CIRCINTERVENTIONS.114.002279.

name: From the Department of Interventional Cardiology, Erasmus University Medical Centre, Thoraxcenter, Rotterdam, The Netherlands (C.M.C., F.C., H.M.G.-G., C.B., P.S., M.V., P.W.S.); Department of Interventional Cardiology Heart Institute (InCor), University of São Paulo Medical School, Sao Paulo, Brazil (C.M.C.); Cardialysis, Rotterdam, The Netherlands (H.M.G.-G., M.-A.M.); Department of Cardiology, Bern University Hospital, Bern, Switzerland (S.W.); and Department of Cardiology, International Centre...

title: Anatomic Characteristics and Clinical Implications of Angiographic Coronary Thrombus

ReferenceCitation: Zhang YJ, Iqbal J, van Klaveren D, Campos CM, Holmes DR, Kappetein AP, Morice MC, Banning AP, Grech ED, Bourantas CV, Onuma Y, Garcia-Garcia HM, Mack MJ, Colombo A, Mohr FW, Steyerberg EW, Serruys PW. Smoking is associated with adverse clinical outcomes in patients undergoing revascularization with PCI or CABG: the SYNTAX trial at 5-year follow-up. J Am Coll Cardiol. 2015 Mar 24;65(11):1107-15. doi: 10.1016/j.jacc.2015.01.014.

title: Smoking Is Associated With Adverse Clinical Outcomes in Patients Undergoing Revascularization With PCI or CABG

ReferenceCitation: Cohen DJ, Osnabrugge RL, Magnuson EA, Wang K, Li H, Chinnakondepalli K, Pinto D, Abdallah MS, Vilain KA, Morice MC, Dawkins KD, Kappetein AP, Mohr FW, Serruys PW; SYNTAX Trial Investigators. Cost-effectiveness of percutaneous coronary intervention with drug-eluting stents versus bypass surgery for patients with 3-vessel or left main coronary artery disease: final results from the Synergy Between Percutaneous Coronary Intervention With TAXUS and Cardiac Surgery (SYNTAX) trial. Circulation. 2014 Sep 30;130(14):1146-57. doi: 10.1161/CIRCULATIONAHA.114.009985. Epub 2014 Aug 1.

name: From Saint Luke’s Mid America Heart Institute, University of Missouri–Kansas City, Kansas City (D.J.C., R.L.O., E.A.M., K.W., H.L., K.C.); Erasmus University Medical Center, Rotterdam, The Netherlands (R.L.O., A.P.K., P.W.S.); Harvard School of Public Health, Boston, MA (D.P.); Institut Jacques Cartier, Massy, France (M.-C.M.); Boston Scientific, Natick, MA (K.D.D.); and Herzzentrum Universität Leipzig, Leipzig, Germany (F.W.M.).

title: Cost-Effectiveness of Percutaneous Coronary Intervention With Drug-Eluting Stents Versus Bypass Surgery for Patients With 3-Vessel or Left Main Coronary Artery Disease

ReferenceCitation: Zhang YJ, Iqbal J, Campos CM, Klaveren DV, Bourantas CV, Dawkins KD, Banning AP, Escaned J, de Vries T, Morel MA, Farooq V, Onuma Y, Garcia-Garcia HM, Stone GW, Steyerberg EW, Mohr FW, Serruys PW. Prognostic value of site SYNTAX score and rationale for combining anatomic and clinical factors in decision making: insights from the SYNTAX trial. J Am Coll Cardiol. 2014 Aug 5;64(5):423-32. doi: 10.1016/j.jacc.2014.05.022.

title: Prognostic Value of Site SYNTAX Score and Rationale for Combining Anatomic and Clinical Factors in Decision Making

ReferenceCitation: Head SJ, Davierwala PM, Serruys PW, Redwood SR, Colombo A, Mack MJ, Morice MC, Holmes DR Jr, Feldman TE, Ståhle E, Underwood P, Dawkins KD, Kappetein AP, Mohr FW. Coronary artery bypass grafting vs. percutaneous coronary intervention for patients with three-vessel disease: final five-year follow-up of the SYNTAX trial. Eur Heart J. 2014 Oct 21;35(40):2821-30. doi: 10.1093/eurheartj/ehu213. Epub 2014 May 21.

title: Coronary artery bypass grafting vs. percutaneous coronary intervention for patients with three-vessel disease: final five-year follow-up of the SYNTAX trial

ReferenceCitation: Morice MC, Serruys PW, Kappetein AP, Feldman TE, Ståhle E, Colombo A, Mack MJ, Holmes DR, Choi JW, Ruzyllo W, Religa G, Huang J, Roy K, Dawkins KD, Mohr F. Five-year outcomes in patients with left main disease treated with either percutaneous coronary intervention or coronary artery bypass grafting in the synergy between percutaneous coronary intervention with taxus and cardiac surgery trial. Circulation. 2014 Jun 10;129(23):2388-94. doi: 10.1161/CIRCULATIONAHA.113.006689. Epub 2014 Apr 3.

name: From the Institut Cardiovasculaire Paris Sud, Hopital Privé Jacques Cartier, Générale de santé, Massy, France (M.-C.M.); Erasmus University Medical Center Rotterdam, Rotterdam, The Netherlands (P.W.S., A.P.K.); Evanston Hospital, Evanston, IL (T.E.F.); University Hospital Uppsala, Uppsala, Sweden (E.S.); San Raffaele Scientific Institute, Milan, Italy (A.C.); Medical City Hospital, Dallas, TX (M.J.M.); Mayo Clinic, Rochester, MN (D.R.H.); Baylor Heart and Vascular Hospital, Dallas, TX (J.W.C.);...

title: Five-Year Outcomes in Patients With Left Main Disease Treated With Either Percutaneous Coronary Intervention or Coronary Artery Bypass Grafting in the Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery Trial

ReferenceCitation: Vranckx P, Kalesan B, Stefanini GG, Farooq V, Onuma Y, Silber S, de Vries T, Jüni P, Serruys PW, Windecker S. Clinical outcome of patients with stable ischaemic heart disease as compared to those with acute coronary syndromes after percutaneous coronary intervention. EuroIntervention. 2015 Jun;11(2):171-9. doi: 10.4244/EIJV11I2A31.

repository_institution: University Library Bern - BORIS - Bern Open Repository and Information System

repositories_institution: University Library Bern - BORIS - Bern Open Repository and Information System

title: Clinical outcome of patients with stable ischaemic heart disease as compared to those with acute coronary syndromes after percutaneous coronary intervention

ReferenceCitation: Farooq V, Serruys PW, Bourantas CV, Zhang Y, Muramatsu T, Feldman T, Holmes DR, Mack M, Morice MC, Ståhle E, Colombo A, de Vries T, Morel MA, Dawkins KD, Kappetein AP, Mohr FW. Quantification of incomplete revascularization and its association with five-year mortality in the synergy between percutaneous coronary intervention with taxus and cardiac surgery (SYNTAX) trial validation of the residual SYNTAX score. Circulation. 2013 Jul 9;128(2):141-51. doi: 10.1161/CIRCULATIONAHA.113.001803. Epub 2013 Jun 13.

name: From the Department of Interventional Cardiology, Erasmus University Medical Center, Thoraxcenter, Rotterdam, The Netherlands (V.F., P.W.S., C.V.B., Y.Z., T.M.); Evanston Hospital, Evanston, IL (T.F.); The Mayo Clinic, Rochester, MN (D.R.H.); Medical City Dallas Hospital, Dallas, TX (M.M.); Institut Jacques Cartier, Massy, France (M.C.M.); University Hospital Uppsala, Uppsala, Sweden (E.S.); San Raffaele Scientific Institute, Milano, Italy (A.C.); Cardialysis BV, Rotterdam, The Netherlands (T.d.V.,...

title: Quantification of Incomplete Revascularization and its Association With Five-Year Mortality in the Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery (SYNTAX) Trial Validation of the Residual SYNTAX Score

ReferenceCitation: Mack MJ, Head SJ, Holmes DR Jr, Ståhle E, Feldman TE, Colombo A, Morice MC, Unger F, Erglis A, Stoler R, Dawkins KD, Serruys PW, Mohr FW, Kappetein AP. Analysis of stroke occurring in the SYNTAX trial comparing coronary artery bypass surgery and percutaneous coronary intervention in the treatment of complex coronary artery disease. JACC Cardiovasc Interv. 2013 Apr;6(4):344-54. doi: 10.1016/j.jcin.2012.11.010. Epub 2013 Mar 20.

title: Analysis of Stroke Occurring in the SYNTAX Trial Comparing Coronary Artery Bypass Surgery and Percutaneous Coronary Intervention in the Treatment of Complex Coronary Artery Disease

ReferenceCitation: Farooq V, van Klaveren D, Steyerberg EW, Meliga E, Vergouwe Y, Chieffo A, Kappetein AP, Colombo A, Holmes DR Jr, Mack M, Feldman T, Morice MC, Ståhle E, Onuma Y, Morel MA, Garcia-Garcia HM, van Es GA, Dawkins KD, Mohr FW, Serruys PW. Anatomical and clinical characteristics to guide decision making between coronary artery bypass surgery and percutaneous coronary intervention for individual patients: development and validation of SYNTAX score II. Lancet. 2013 Feb 23;381(9867):639-50. doi: 10.1016/S0140-6736(13)60108-7.

ReferenceCitation: Mohr FW, Morice MC, Kappetein AP, Feldman TE, Ståhle E, Colombo A, Mack MJ, Holmes DR Jr, Morel MA, Van Dyck N, Houle VM, Dawkins KD, Serruys PW. Coronary artery bypass graft surgery versus percutaneous coronary intervention in patients with three-vessel disease and left main coronary disease: 5-year follow-up of the randomised, clinical SYNTAX trial. Lancet. 2013 Feb 23;381(9867):629-38. doi: 10.1016/S0140-6736(13)60141-5.

ReferenceCitation: Head SJ, Holmes DR Jr, Mack MJ, Serruys PW, Mohr FW, Morice MC, Colombo A, Kappetein AP; SYNTAX Investigators. Risk profile and 3-year outcomes from the SYNTAX percutaneous coronary intervention and coronary artery bypass grafting nested registries. JACC Cardiovasc Interv. 2012 Jun;5(6):618-25. doi: 10.1016/j.jcin.2012.02.013.

title: Risk Profile and 3-Year Outcomes From the SYNTAX Percutaneous Coronary Intervention and Coronary Artery Bypass Grafting Nested Registries

ReferenceCitation: Serruys PW, Farooq V, Vranckx P, Girasis C, Brugaletta S, Garcia-Garcia HM, Holmes DR Jr, Kappetein AP, Mack MJ, Feldman T, Morice MC, Ståhle E, James S, Colombo A, Pereda P, Huang J, Morel MA, Van Es GA, Dawkins KD, Mohr FW, Steyerberg EW. A global risk approach to identify patients with left main or 3-vessel disease who could safely and efficaciously be treated with percutaneous coronary intervention: the SYNTAX Trial at 3 years. JACC Cardiovasc Interv. 2012 Jun;5(6):606-17. doi: 10.1016/j.jcin.2012.03.016.

title: A Global Risk Approach to Identify Patients With Left Main or 3-Vessel Disease Who Could Safely and Efficaciously Be Treated With Percutaneous Coronary Intervention

ReferenceCitation: Arnold SV, Magnuson EA, Wang K, Serruys PW, Kappetein AP, Mohr FW, Cohen DJ; SYNTAX Investigators. Do differences in repeat revascularization explain the antianginal benefits of bypass surgery versus percutaneous coronary intervention?: implications for future treatment comparisons. Circ Cardiovasc Qual Outcomes. 2012 May;5(3):267-75. doi: 10.1161/CIRCOUTCOMES.111.964585. Epub 2012 Apr 10.

name: From the St. Luke's Mid America Heart Institute, Kansas City, MO (S.V.A., E.A.M., K.W., D.J.C.); Erasmus University Medical Center Rotterdam, Rotterdam, the Netherlands (P.W.S., A.P.K.); Herzzentrum Universität Leipzig, Leipzig, Germany (F.W.M.).

journal_name: Circulation: Cardiovascular Quality and Outcomes

title: Do Differences in Repeat Revascularization Explain the Antianginal Benefits of Bypass Surgery Versus Percutaneous Coronary Intervention?

ReferenceCitation: Morice MC, Feldman TE, Mack MJ, Ståhle E, Holmes DR, Colombo A, Morel MA, van den Brand M, Serruys PW, Mohr F, Carrié D, Fournial G, James S, Leadley K, Dawkins KD, Kappetein AP. Angiographic outcomes following stenting or coronary artery bypass surgery of the left main coronary artery: fifteen-month outcomes from the synergy between PCI with TAXUS express and cardiac surgery left main angiographic substudy (SYNTAX-LE MANS). EuroIntervention. 2011 Oct 30;7(6):670-9. doi: 10.4244/EIJV7I6A109.

ReferenceCitation: Cohen DJ, Van Hout B, Serruys PW, Mohr FW, Macaya C, den Heijer P, Vrakking MM, Wang K, Mahoney EM, Audi S, Leadley K, Dawkins KD, Kappetein AP; Synergy between PCI with Taxus and Cardiac Surgery Investigators. Quality of life after PCI with drug-eluting stents or coronary-artery bypass surgery. N Engl J Med. 2011 Mar 17;364(11):1016-26. doi: 10.1056/NEJMoa1001508.

title: Quality of Life after PCI with Drug-Eluting Stents or Coronary-Artery Bypass Surgery

ReferenceCitation: Mohr FW, Rastan AJ, Serruys PW, Kappetein AP, Holmes DR, Pomar JL, Westaby S, Leadley K, Dawkins KD, Mack MJ. Complex coronary anatomy in coronary artery bypass graft surgery: impact of complex coronary anatomy in modern bypass surgery? Lessons learned from the SYNTAX trial after two years. J Thorac Cardiovasc Surg. 2011 Jan;141(1):130-40. doi: 10.1016/j.jtcvs.2010.07.094.

title: Complex coronary anatomy in coronary artery bypass graft surgery: Impact of complex coronary anatomy in modern bypass surgery? Lessons learned from the SYNTAX trial after two years

ReferenceCitation: Morice MC, Serruys PW, Kappetein AP, Feldman TE, Ståhle E, Colombo A, Mack MJ, Holmes DR, Torracca L, van Es GA, Leadley K, Dawkins KD, Mohr F. Outcomes in patients with de novo left main disease treated with either percutaneous coronary intervention using paclitaxel-eluting stents or coronary artery bypass graft treatment in the Synergy Between Percutaneous Coronary Intervention with TAXUS and Cardiac Surgery (SYNTAX) trial. Circulation. 2010 Jun 22;121(24):2645-53. doi: 10.1161/CIRCULATIONAHA.109.899211. Epub 2010 Jun 7.

name: From the Institut Hospitalier Jacques Cartier, Massy, France (M.M.); Erasmus University Medical Center Rotterdam, Rotterdam, the Netherlands (P.W.S., A.P.K.); Evanston Hospital, Evanston, Ill (T.E.F.); University Hospital Uppsala, Uppsala, Sweden (E.S.); San Raffaele Scientific Institute, Milan, Italy (A.C., L.T.); Heart Hospital Baylor Plano, Dallas, Tex (M.J.M.); Mayo Clinic, Rochester, Minn (D.R.H.); Cardialysis, Rotterdam, the Netherlands (G.v.E.); Boston Scientific Corp, Natick, Mass (K.L., K.D...

title: Outcomes in Patients With De Novo Left Main Disease Treated With Either Percutaneous Coronary Intervention Using Paclitaxel-Eluting Stents or Coronary Artery Bypass Graft Treatment in the Synergy Between Percutaneous Coronary Intervention With TAXUS and Cardiac Surgery (SYNTAX) Trial

ReferenceCitation: Banning AP, Westaby S, Morice MC, Kappetein AP, Mohr FW, Berti S, Glauber M, Kellett MA, Kramer RS, Leadley K, Dawkins KD, Serruys PW. Diabetic and nondiabetic patients with left main and/or 3-vessel coronary artery disease: comparison of outcomes with cardiac surgery and paclitaxel-eluting stents. J Am Coll Cardiol. 2010 Mar 16;55(11):1067-75. doi: 10.1016/j.jacc.2009.09.057. Epub 2010 Jan 14.

title: Diabetic and Nondiabetic Patients With Left Main and/or 3-Vessel Coronary Artery Disease

ReferenceCitation: Serruys PW, Morice MC, Kappetein AP, Colombo A, Holmes DR, Mack MJ, Ståhle E, Feldman TE, van den Brand M, Bass EJ, Van Dyck N, Leadley K, Dawkins KD, Mohr FW; SYNTAX Investigators. Percutaneous coronary intervention versus coronary-artery bypass grafting for severe coronary artery disease. N Engl J Med. 2009 Mar 5;360(10):961-72. doi: 10.1056/NEJMoa0804626. Epub 2009 Feb 18. Erratum in: N Engl J Med. 2013 Feb 7;368(6):584.

repository_institution: University of Debrecen - University of Debrecen Electronic Archive

repositories_institution: University of Debrecen - University of Debrecen Electronic Archive

title: Percutaneous Coronary Intervention versus Coronary-Artery Bypass Grafting for Severe Coronary Artery Disease

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location_facility: Medical University of Silesia - Katowice

location_facility: Oklahoma Foundation for Cardiovascular Research

location_facility: Herz- und Diabeteszentrum Nordrhein-Westfalen

location_facility: Karolinska Universitets Sjukhuset - Stockholm

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title: A Randomized, Double-blind Study of Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab Versus Placebo, in Combination With Methotrexate, in Patients With Moderate to Severe Rheumatoid Arthritis

summary: This 3 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo, both in combination with methotrexate (MTX). in patients with moderate to severe active rheumatoid arthritis (RA) who currently have an inadequate response to MTX. Patients wil be randomized to receive tocilizumab 4mg/kg iv, tocilizumab 8mg/mg iv, or placebo iv, every 4 weeks; all patients will also receive methotrexate 10-25mg weekly. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Keystone EC, Anisfeld A, Ogale S, Devenport JN, Curtis JR. Continued benefit of tocilizumab plus disease-modifying antirheumatic drug therapy in patients with rheumatoid arthritis and inadequate clinical responses by week 8 of treatment. J Rheumatol. 2014 Feb;41(2):216-26. doi: 10.3899/jrheum.130489. Epub 2014 Jan 15.

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publisher: The Journal of Rheumatology

publisher_dissemination: The Journal of Rheumatology

publisher_group: The Journal of Rheumatology

publisher_normalized: The Journal of Rheumatology

title: Continued Benefit of Tocilizumab Plus Disease-modifying Antirheumatic Drug Therapy in Patients with Rheumatoid Arthritis and Inadequate Clinical Responses by Week 8 of Treatment

ReferenceCitation: Wang J, Bansal AT, Martin M, Germer S, Benayed R, Essioux L, Lee JS, Begovich A, Hemmings A, Kenwright A, Taylor KE, Upmanyu R, Cutler P, Harari O, Marchini J, Criswell LA, Platt A. Genome-wide association analysis implicates the involvement of eight loci with response to tocilizumab for the treatment of rheumatoid arthritis. Pharmacogenomics J. 2013 Jun;13(3):235-41. doi: 10.1038/tpj.2012.8. Epub 2012 Apr 10.

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ReferenceCitation: Garnero P, Thompson E, Woodworth T, Smolen JS. Rapid and sustained improvement in bone and cartilage turnover markers with the anti-interleukin-6 receptor inhibitor tocilizumab plus methotrexate in rheumatoid arthritis patients with an inadequate response to methotrexate: results from a substudy of the multicenter double-blind, placebo-controlled trial of tocilizumab in inadequate responders to methotrexate alone. Arthritis Rheum. 2010 Jan;62(1):33-43. doi: 10.1002/art.25053.

title: Rapid and sustained improvement in bone and cartilage turnover markers with the antiâinterleukin-6 receptor inhibitor tocilizumab plus methotrexate in rheumatoid arthritis patients with an inadequate response to methotrexate: Results from a substudy of the multicenter double-blind, placebo-controlled trial of tocilizumab in inadequate responders to methotrexate alone

ReferenceCitation: Smolen JS, Beaulieu A, Rubbert-Roth A, Ramos-Remus C, Rovensky J, Alecock E, Woodworth T, Alten R; OPTION Investigators. Effect of interleukin-6 receptor inhibition with tocilizumab in patients with rheumatoid arthritis (OPTION study): a double-blind, placebo-controlled, randomised trial. Lancet. 2008 Mar 22;371(9617):987-97. doi: 10.1016/S0140-6736(08)60453-5.

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type: EudraCT Number

title: PHASE 1/2 STUDY OF PF-06463922 (AN ALK/ROS1 TYROSINE KINASE INHIBITOR) IN PATIENTS WITH ADVANCED NON-SMALL CELL LUNG CANCER HARBORING SPECIFIC MOLECULAR ALTERATIONS

summary: Phase 1 and 2 trial to study the safety, pharmacokinetics, pharmacodynamics, patient reported outcomes and efficacy of PF-06463922 in ALK + advanced non-small cell lung cancer patients and ROS1+ advanced non small cell lung cancer patients .

study_start_date_type: Actual

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ReferenceCitation: Chen J, Ruiz-Garcia A, James LP, Peltz G, Thurm H, Clancy J, Hibma J. Lorlatinib Exposure-Response Analyses for Safety and Efficacy in a Phase I/II Trial to Support Benefit-Risk Assessment in Non-Small Cell Lung Cancer. Clin Pharmacol Ther. 2021 Nov;110(5):1273-1281. doi: 10.1002/cpt.2228. Epub 2021 Jun 26.

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title: Lorlatinib Exposure‐Response Analyses for Safety and Efficacy in a Phase I/II Trial to Support Benefit–Risk Assessment in Non‐Small Cell Lung Cancer

ReferenceCitation: Chen J, O'Gorman MT, James LP, Klamerus KJ, Mugundu G, Pithavala YK. Pharmacokinetics of Lorlatinib After Single and Multiple Dosing in Patients with Anaplastic Lymphoma Kinase (ALK)-Positive Non-Small Cell Lung Cancer: Results from a Global Phase I/II Study. Clin Pharmacokinet. 2021 Oct;60(10):1313-1324. doi: 10.1007/s40262-021-01015-z. Epub 2021 May 3.

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ReferenceCitation: Peters S, Shaw AT, Besse B, Felip E, Solomon BJ, Soo RA, Bearz A, Gadgeel SM, Lin CC, Kao S, Seto T, Masters ET, Abbattista A, Clancy JS, Thurm H, Reisman A, Peltz G, Ross Camidge D. Impact of lorlatinib on patient-reported outcomes in patients with advanced ALK-positive or ROS1-positive non-small cell lung cancer. Lung Cancer. 2020 Jun;144:10-19. doi: 10.1016/j.lungcan.2020.02.011. Epub 2020 Mar 10.

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ReferenceCitation: Bauer TM, Shaw AT, Johnson ML, Navarro A, Gainor JF, Thurm H, Pithavala YK, Abbattista A, Peltz G, Felip E. Brain Penetration of Lorlatinib: Cumulative Incidences of CNS and Non-CNS Progression with Lorlatinib in Patients with Previously Treated ALK-Positive Non-Small-Cell Lung Cancer. Target Oncol. 2020 Feb;15(1):55-65. doi: 10.1007/s11523-020-00702-4.

ReferenceCitation: Shaw AT, Solomon BJ, Chiari R, Riely GJ, Besse B, Soo RA, Kao S, Lin CC, Bauer TM, Clancy JS, Thurm H, Martini JF, Peltz G, Abbattista A, Li S, Ou SI. Lorlatinib in advanced ROS1-positive non-small-cell lung cancer: a multicentre, open-label, single-arm, phase 1-2 trial. Lancet Oncol. 2019 Dec;20(12):1691-1701. doi: 10.1016/S1470-2045(19)30655-2. Epub 2019 Oct 25.

title: Lorlatinib in advanced ROS1-positive non-small-cell lung cancer: a multicentre, open-label, single-arm, phase 1–2 trial

ReferenceCitation: Solomon BJ, Besse B, Bauer TM, Felip E, Soo RA, Camidge DR, Chiari R, Bearz A, Lin CC, Gadgeel SM, Riely GJ, Tan EH, Seto T, James LP, Clancy JS, Abbattista A, Martini JF, Chen J, Peltz G, Thurm H, Ou SI, Shaw AT. Lorlatinib in patients with ALK-positive non-small-cell lung cancer: results from a global phase 2 study. Lancet Oncol. 2018 Dec;19(12):1654-1667. doi: 10.1016/S1470-2045(18)30649-1. Epub 2018 Nov 6. Erratum in: Lancet Oncol. 2019 Jan;20(1):e10.

ReferenceCitation: Shaw AT, Felip E, Bauer TM, Besse B, Navarro A, Postel-Vinay S, Gainor JF, Johnson M, Dietrich J, James LP, Clancy JS, Chen J, Martini JF, Abbattista A, Solomon BJ. Lorlatinib in non-small-cell lung cancer with ALK or ROS1 rearrangement: an international, multicentre, open-label, single-arm first-in-man phase 1 trial. Lancet Oncol. 2017 Dec;18(12):1590-1599. doi: 10.1016/S1470-2045(17)30680-0. Epub 2017 Oct 23.

repository_institution: University of Melbourne - Minerva Access

ReferenceCitation: Shaw AT, Friboulet L, Leshchiner I, Gainor JF, Bergqvist S, Brooun A, Burke BJ, Deng YL, Liu W, Dardaei L, Frias RL, Schultz KR, Logan J, James LP, Smeal T, Timofeevski S, Katayama R, Iafrate AJ, Le L, McTigue M, Getz G, Johnson TW, Engelman JA. Resensitization to Crizotinib by the Lorlatinib ALK Resistance Mutation L1198F. N Engl J Med. 2016 Jan 7;374(1):54-61. doi: 10.1056/NEJMoa1508887. Epub 2015 Dec 23.

title: Resensitization to Crizotinib by the LorlatinibALKResistance Mutation L1198F

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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Canada
Korea, Republic of
Taiwan

location_facility: Institut Gustave Roussy (comite poumon-pneumologie)

location_facility: Sarah Cannon Research Institute (Pharmacy)

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: National University Hospital Medical Centre

location_facility: Department of Clinical Oncology, Prince of Wales Hospital

location_facility: Smilow Cancer Hospital at Yale-New Haven

location_facility: Washington University School of Medicine

location_facility: Dipartimento di Oncologia Medica, UO Medicina 1Q A, Unita' Nuovi Farmaci e Terapie Innovative

location_facility: Rockefeller Patient Pavilion - Memorial Sloan Kettering

location_facility: Unita di Farmacologia Clinica e Nuovi Farmaci

location_facility: CHU de Rennes - Hôpital Pontchaillou - CIC Inserm

location_facility: Hospital Universitari de la Vall D'Hebron Edificio General. Planta Baja. UITM. Servicio de Oncologia

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: Institut Universitaire du Cancer de Toulouse (IUCT-O)

location_facility: British Columbia Cancer Agency-Vancouver Centre

location_facility: Washington University Infusion Center Pharmacy

location_facility: Seoul National University Hospital / Department of Internal Medicine

location_facility: Institut Gustave Roussy- Pharmacie-Unite Essais Cliniques


title: Efficacy and Safety Comparison of Insulin Detemir Plus Insulin Aspart Versus Insulin Glargine Plus Insulin Aspart in Type 1 Diabetes

summary: This trial is conducted in Europe and the United States of America (USA). The purpose of this study is to test whether insulin detemir is a safe and at least as effective alternative to insulin glargine for the control of blood glucose in basal/bolus therapy in patients with type I diabetes.

ReferenceType: result

ReferenceCitation: Heller S, Koenen C, Bode B. Comparison of insulin detemir and insulin glargine in a basal-bolus regimen, with insulin aspart as the mealtime insulin, in patients with type 1 diabetes: a 52-week, multinational, randomized, open-label, parallel-group, treat-to-target noninferiority trial. Clin Ther. 2009 Oct;31(10):2086-97. doi: 10.1016/j.clinthera.2009.10.006.

family: Heller

full_name: Simon Heller

given: Simon

family: Koenen

full_name: Christoph Koenen

given: Christoph

family: Bode

full_name: Bruce Bode

given: Bruce

journal_name: Clinical Therapeutics

oa_host_type: repository

evidence: oa repository (via OAI-PMH doi match)

version: acceptedVersion

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Comparison of insulin detemir and insulin glargine in a basal—bolus regimen, with insulin aspart as the mealtime insulin, in patients with type 1 diabetes: A 52-week, multinational, randomized, open-label, parallel-group, Treat-to-Target noninferiority trial

lead_sponsor: Novo Nordisk A/S

location_country:
United States
Sweden
Netherlands
Finland
France
Germany
United Kingdom

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A Randomized, Open-label Study of the Effect of Maintenance Mircera Administered With Pre-filled Syringes on Hemoglobin Levels in Anemic Dialysis Patients With Chronic Kidney Disease

summary: This study will assess the efficacy and safety of intravenous (iv) or subcutaneous (sc) Mircera, administered with pre-filled syringes, as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv or sc epoetin. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.

lead_sponsor: Hoffmann-La Roche

location_country:
Italy
United States
Spain
France
Poland
Thailand
Puerto Rico
Portugal
Germany
United Kingdom
Canada
Taiwan


title: Phase II Study of Novel Epothilone (BMS-247550) in Patients With MBC Who Are Refractory to an Anthracycline, a Taxane, and Capecitabine

summary: The purpose of this research study is to assess the response rate of the investigational drug BMS-247550 (Ixabepilone) in women with metastatic breast cancer who are refractory to an anthracycline, a taxane, and capecitabine.

ReferenceType: background

ReferenceCitation: Perez EA, Lerzo G, Pivot X, Thomas E, Vahdat L, Bosserman L, Viens P, Cai C, Mullaney B, Peck R, Hortobagyi GN. Efficacy and safety of ixabepilone (BMS-247550) in a phase II study of patients with advanced breast cancer resistant to an anthracycline, a taxane, and capecitabine. J Clin Oncol. 2007 Aug 10;25(23):3407-14. Epub 2007 Jul 2.

lead_sponsor: R-Pharm

location_country:
United States
South Africa
Sweden
Mexico
Netherlands
Germany
France
Norway
Argentina
Canada


type: Other Identifier

title: Open-Label Extension Study of EFC12492, R727-CL-1112, EFC12732 and LTS11717 Studies to Assess the Long-Term Safety and Efficacy of Alirocumab in Patients With Heterozygous Familial Hypercholesterolemia

acronym: ODYSSEY OLE

summary:
Primary Objective:

To assess the long-term safety of alirocumab (SAR236553/REGN727) when added to lipid-lowering therapy in participants with heterozygous familial hypercholesterolemia (heFH) who had completed EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500), EFC12732 (NCT01617655) and LTS11717 (NCT01507831).

Secondary Objectives:

To evaluate the long-term efficacy of alirocumab on lipid parameters.
To evaluate the long-term immunogenicity of alirocumab.

ReferenceCitation: Dufour R, Hovingh GK, Guyton JR, Langslet G, Baccara-Dinet MT, Din-Bell C, Manvelian G, Farnier M. Individualized low-density lipoprotein cholesterol reduction with alirocumab titration strategy in heterozygous familial hypercholesterolemia: Results from an open-label extension of the ODYSSEY LONG TERM trial. J Clin Lipidol. 2019 Jan - Feb;13(1):138-147. doi: 10.1016/j.jacl.2018.11.007. Epub 2018 Nov 30.

family: Dufour

full_name: Robert Dufour

given: Robert

family: Hovingh

full_name: G. Kees Hovingh

given: G. Kees

family: Guyton

full_name: John R. Guyton

given: John R.

family: Langslet

full_name: Gisle Langslet

given: Gisle

family: Baccara-Dinet

full_name: Marie T. Baccara-Dinet

given: Marie T.

family: Din-Bell

full_name: Chantal Din-Bell

given: Chantal

family: Manvelian

full_name: Garen Manvelian

given: Garen

family: Farnier

full_name: Michel Farnier

given: Michel

journal_name: Journal of Clinical Lipidology

ReferenceCitation: Farnier M, Hovingh GK, Langslet G, Dufour R, Baccara-Dinet MT, Din-Bell C, Manvelian G, Guyton JR. Long-term safety and efficacy of alirocumab in patients with heterozygous familial hypercholesterolemia: An open-label extension of the ODYSSEY program. Atherosclerosis. 2018 Nov;278:307-314. doi: 10.1016/j.atherosclerosis.2018.08.036. Epub 2018 Sep 1.

journal_name: Atherosclerosis

ReferenceCitation: Hovingh GK, Guyton JR, Langslet G, Dufour R, Baccara-Dinet MT, Din-Bell C, Manvelian G, Farnier M. Alirocumab dosing patterns during 40 months of open-label treatment in patients with heterozygous familial hypercholesterolemia. J Clin Lipidol. 2018 Nov - Dec;12(6):1463-1470. doi: 10.1016/j.jacl.2018.08.011. Epub 2018 Aug 30.

location_country:
Finland
Romania
Belgium
Russian Federation
Denmark
France
Norway
Argentina
Canada
South Africa
Sweden
Netherlands
Bulgaria
Hungary
Portugal
Germany
United States
United Kingdom
Italy
Austria
Mexico
Czechia
Israel
Spain

location_facility:
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title: A Randomized Parallel-group, Placebo-controlled, Double-blind, Multi-center Dose Finding Phase II Trial Exploring the Pharmacodynamic Effects, Safety and Tolerability, and Pharmacokinetics of Four Dose Regimens of the Oral sGC Stimulator BAY1021189 Over 12 Weeks in Patients With Worsening Heart Failure With Reduced Ejection Fraction (HFrEF)

summary: Objective of the study is to find the optimal dose of the once daily oral soluble guanylate cyclase stimulator (sGC) BAY1021189 for Phase III that can be given in addition to standard therapy for heart failure with reduced ejection fraction (HFrEF).

ReferenceCitation: Pieske B, Butler J, Filippatos G, Lam C, Maggioni AP, Ponikowski P, Shah S, Solomon S, Kraigher-Krainer E, Samano ET, Scalise AV, Müller K, Roessig L, Gheorghiade M; SOCRATES Investigators and Coordinators. Rationale and design of the SOluble guanylate Cyclase stimulatoR in heArT failurE Studies (SOCRATES). Eur J Heart Fail. 2014 Sep;16(9):1026-38. doi: 10.1002/ejhf.135. Epub 2014 Jul 24.

name: Department of Cardiology; Medical University Graz; Graz Austria

family: Pieske

full_name: Burkert Pieske

given: Burkert

name: Division of Cardiology; Emory University School of Medicine; Atlanta GA USA

family: Butler

full_name: Javed Butler

given: Javed

name: Department of Cardiology; University Hospital Attikon; Athens Greece

family: Filippatos

full_name: Gerasimos Filippatos

given: Gerasimos

name: Cardiovascular Research Institute; Singapore

family: Lam

full_name: Carolyn Lam

given: Carolyn

name: Associazione Nazionale Medici Cardiologi Ospedalieri Research Center; Florence Italy

family: Maggioni

full_name: Aldo Pietro Maggioni

given: Aldo Pietro

name: Department of Heart Diseases; Medical University; Military Hospital Wroclaw Poland

family: Ponikowski

full_name: Piotr Ponikowski

given: Piotr

name: Division of Cardiology, Department of Medicine; Northwestern University Feinberg School of Medicine; Chicago IL USA

family: Shah

full_name: Sanjiv Shah

given: Sanjiv

name: Cardiovascular Division; Brigham and Women's Hospital; Boston MA USA

family: Solomon

full_name: Scott Solomon

given: Scott

family: Kraigher-Krainer

full_name: Elisabeth Kraigher-Krainer

given: Elisabeth

family: Samano

full_name: Eliana Tibana Samano

given: Eliana Tibana

family: Scalise

full_name: Andrea Viviana Scalise

given: Andrea Viviana

family: Müller

full_name: Katharina Müller

given: Katharina

family: Roessig

full_name: Lothar Roessig

given: Lothar

family: Gheorghiade

full_name: Mihai Gheorghiade

given: Mihai

name: on behalf of the SOCRATES Investigators and Coordinators

journal_name: European Journal of Heart Failure

ReferenceCitation: Gheorghiade M, Greene SJ, Butler J, Filippatos G, Lam CS, Maggioni AP, Ponikowski P, Shah SJ, Solomon SD, Kraigher-Krainer E, Samano ET, Müller K, Roessig L, Pieske B; SOCRATES-REDUCED Investigators and Coordinators. Effect of Vericiguat, a Soluble Guanylate Cyclase Stimulator, on Natriuretic Peptide Levels in Patients With Worsening Chronic Heart Failure and Reduced Ejection Fraction: The SOCRATES-REDUCED Randomized Trial. JAMA. 2015 Dec 1;314(21):2251-62. doi: 10.1001/jama.2015.15734.

name: Center for Cardiovascular Innovation, Northwestern University Feinberg School of Medicine, Chicago, Illinois

name: Division of Cardiology, Duke University Medical Center, Durham, North Carolina

family: Greene

full_name: Stephen J. Greene

given: Stephen J.

name: Division of Cardiology, Stony Brook University, Stony Brook, New York

name: Heart Failure Unit, Department of Cardiology, Athens University Hospital Attikon, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece

name: Department of Cardiology, National Heart Centre Singapore and Duke, National University of Singapore, Singapore

full_name: Carolyn S. P. Lam

given: Carolyn S. P.

name: Associazione Nazionale Medici Cardiologi Ospedalieri Research Center, Florence, Italy

full_name: Aldo P. Maggioni

given: Aldo P.

name: Department of Heart Diseases, Medical University, Military Hospital, Wroclaw, Poland

name: Division of Cardiology, Northwestern University Feinberg School of Medicine, Chicago, Illinois

name: Cardiovascular Division, Brigham and Women’s Hospital, Boston, Massachusetts

name: Department of Internal Medicine and Cardiology, Charité University Medicine Berlin–Campus Virchow Klinikum, Berlin, Germany13Department of Internal Medicine and Cardiology, German Heart Center Berlin, Berlin, Germany

name: for the SOCRATES-REDUCED Investigators and Coordinators

ReferenceCitation: Ruehs H, Klein D, Frei M, Grevel J, Austin R, Becker C, Roessig L, Pieske B, Garmann D, Meyer M. Population Pharmacokinetics and Pharmacodynamics of Vericiguat in Patients with Heart Failure and Reduced Ejection Fraction. Clin Pharmacokinet. 2021 Nov;60(11):1407-1421. doi: 10.1007/s40262-021-01024-y. Epub 2021 Jun 4.

ReferenceCitation: Kramer F, Voss S, Roessig L, Igl BW, Butler J, Lam CSP, Maggioni AP, Shah SJ, Pieske B. Evaluation of high-sensitivity C-reactive protein and uric acid in vericiguat-treated patients with heart failure with reduced ejection fraction. Eur J Heart Fail. 2020 Sep;22(9):1675-1683. doi: 10.1002/ejhf.1787. Epub 2020 Mar 25.

name: Medical Devices and eHealth Clinical Bayer AG  Wuppertal Germany

name: Chrestos Concept GmbH & Co. KG  Essen Germany

name: Clinical Development Bayer AG  Wuppertal Germany

name: Research and Clinical Sciences Statistics Bayer AG  Berlin Germany

name: Department of Medicine University of Mississippi Medical Center  Jackson MS USA

name: National Heart Centre and Duke University–National University of Singapore  Singapore Singapore

name: University Medical Centre Groningen  Groningen the Netherlands

name: The George Institute for Global Health  Sydney NSW Australia

name: Italian Association of Hospital Cardiologists (ANMCO) Research Centre  Florence Italy

name: Division of Cardiology, Department of Medicine Northwestern University Feinberg School of Medicine  Chicago IL USA

name: Department of Internal Medicine and Cardiology Campus Virchow Klinikum, Charité Universitätsmedizin Berlin  Berlin Germany

name: German Heart Centre Berlin (DHZB)  Berlin Germany

name: Berlin Institute of Health (BIH)  Berlin Germany

name: German Centre for Cardiovascular Research (DZHK), partner site Berlin  Berlin Germany

title: Evaluation of high‐sensitivity C‐reactive protein and uric acid in vericiguat‐treated patients with heart failure with reduced ejection fraction

location_country:
Greece
Australia
Belgium
Denmark
Taiwan
France
Japan
Poland
Canada
Korea, Republic of
Sweden
Switzerland
Netherlands
Bulgaria
Singapore
Hungary
Germany
United States
United Kingdom
Italy
Austria
Czechia
Israel
Spain


title: Safety and Antiviral Efficacy of a Novel HIV-1 Protease Inhibitor, BMS-232632, in Combination Regimen(s) as Compared to a Reference Combination Regimen(s) in Antiretroviral-Experienced HIV-Infected Subjects

summary: The purpose of this study is to look at the safety and effectiveness of an experimental protease inhibitor (a type of anti-HIV drug) called BMS-232632. Doctors will compare an anti-HIV drug combination that includes BMS-232632 to a drug combination that includes ritonavir.

ReferenceCitation: Haas DW, Zala C, Schrader S,Thiry A, McGovern R, Schnittman S. AI424009: Atazanavir plus Saquinavir once daily favorably affects total cholesterol (TC), fasting triglyceride (TG), and fasting LDL cholesterol (LDL) profiles in patients failing prior therapy week 48. 9th Conf on Retroviruses and Opportunistic Infect. 2002 Feb 24-28 (abstract no 42)

ReferenceCitation: Haas DW, Zala C, Schrader S,Thiry A, McGovern R, Schnittman S. AI424-009: Once-Daily Atazanavir plus Saquinavir favorably affects total cholesterol and fasting triglycerides in patients failing prior PI therapy study BMS-009,week 24. 41st Annual Conf on Antimicrobial Agents and Chemotherapy. 2001 Feb 16-19 (abstract no LB-16)

lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
United States
France
Germany
Canada

location_facility: Louisiana State Univ Med Ctr / HIV Outpatient Clinic

location_facility: Univ of Texas Southwestern Med Ctr of Dallas

location_facility: St Vincents Hosp / Clinical Research Program

location_facility: Univ of California - Davis Med Ctr / CARES

location_facility: Yale Univ School of Medicine / AIDS Program

location_facility: Infectious Disease Specialists of Atlanta

location_facility: Houston Clinical Research Network / Div of Montrose Clinic

location_facility: Clinical Malattie Infettive / Univ Modena

location_facility: Community Research Initiative of South Florida


title: A Randomized Phase III Multicenter Trial of Neoadjuvant Docetaxel (Taxotere) Plus Cisplatin Plus 5-Fluorouracil Versus Neoadjuvant Cisplatin Plus 5-Fluorouracil in Patients With Locally Advanced Inoperable Squamous Cell Carcinoma of the Head and Neck

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one drug and combining chemotherapy with radiation therapy may kill more tumor cells. It is not yet known which regimen of combination chemotherapy is more effective for advanced head and neck cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of combination chemotherapy plus radiation therapy in treating patients who have advanced head and neck cancer.

ReferenceCitation: Jansen J, Vermorken JB, Boote D, et al.: Cost-effectiveness analysis of the EORTC 24971 (TAX 323) trial comparing docetaxel plus cisplatin and 5-fluorouracil versus standard treatment (cisplatin and 5-fluorouracil) as induction chemotherapy followed by radiation therapy in locally advanced unresectable squamous cell carcinoma of the head and neck (SCCHN). [Abstract] J Clin Oncol 25 (Suppl 18): A-6090, 321s, 2007.

ReferenceCitation: van Herpen CM, Mauer ME, Mesia R, Degardin M, Jelic S, Coens C, Betka J, Bernier J, Remenar E, Stewart JS, Preiss JH, van den Weyngaert D, Bottomley A, Vermorken JB; EORTC Head and Neck Group. Short-term health-related quality of life and symptom control with docetaxel, cisplatin, 5-fluorouracil and cisplatin (TPF), 5-fluorouracil (PF) for induction in unresectable locoregionally advanced head and neck cancer patients (EORTC 24971/TAX 323). Br J Cancer. 2010 Oct 12;103(8):1173-81. doi: 10.1038/sj.bjc.6605860. Epub 2010 Sep 14.

family: van Herpen

full_name: C M L van Herpen

given: C M L

name: on behalf of the EORTC Head and Neck Group

family: Mauer

full_name: M E Mauer

given: M E

family: Mesia

full_name: R Mesia

given: R

family: Degardin

full_name: M Degardin

given: M

family: Jelic

full_name: S Jelic

given: S

family: Coens

full_name: C Coens

given: C

family: Betka

full_name: J Betka

given: J

family: Bernier

full_name: J Bernier

family: Remenar

full_name: E Remenar

given: E

family: Stewart

full_name: J S Stewart

given: J S

family: Preiss

full_name: J H Preiss

given: J H

family: van den Weyngaert

full_name: D van den Weyngaert

given: D

family: Bottomley

full_name: A Bottomley

given: A

family: Vermorken

full_name: J B Vermorken

given: J B

journal_name: British Journal of Cancer

evidence: open (via page says license)

license: cc-by-nc-sa

license_normalized: cc-by-nc-sa

license: implied-oa

license_normalized: implied-oa

repository_institution: PubMed Central - Europe PMC

publisher_dissemination: Springer

publisher_group: Springer

ReferenceCitation: Vermorken JB, Remenar E, van Herpen C, Gorlia T, Mesia R, Degardin M, Stewart JS, Jelic S, Betka J, Preiss JH, van den Weyngaert D, Awada A, Cupissol D, Kienzer HR, Rey A, Desaunois I, Bernier J, Lefebvre JL; EORTC 24971/TAX 323 Study Group. Cisplatin, fluorouracil, and docetaxel in unresectable head and neck cancer. N Engl J Med. 2007 Oct 25;357(17):1695-704.

ReferenceCitation: Bernier J, Coens C, Remenar E, et al.: Impact on quality of life (QoL) of the addition of docetaxel (T) to neoadjuvant cisplatin plus 5-fluorouracil treatment in patients with locally advanced unresectable squamous cell carcinoma of the head and neck (SCCHN): EORTC study 24971. [Abstract] J Clin Oncol 24 (Suppl 18): A-5522, 285s, 2006.

ReferenceCitation: Remenar E, Van Herpen C, Lluch JG, et al.: A randomized phase III multicenter trial of neoadjuvant docetaxel plus cisplatin and 5-fluorouracil (TPF) versus neoadjuvant PF in patients with locally advanced unresectable squamous cell carcinoma of the head and neck (SCCHN). Final analysis of EORTC 24971. [Abstract] J Clin Oncol 24 (Suppl 18): A-5516, 2006.

ReferenceCitation: Vermorken JB, Remenar E, Van Herpen C, et al.: Standard cisplatin/infusional 5-fluorouracil (PF) vs docetaxel (T) plus PF (TPF) as neoadjuvant chemotherapy for nonresectable locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN): a phase III trial of the EORTC Head and Neck Cancer Group (EORTC #24971). [Abstract] J Clin Oncol 22 (Suppl 14): A-5508, 490s, 2004.

lead_sponsor: European Organisation for Research and Treatment of Cancer - EORTC

location_country:
Italy
Austria
Former Yugoslavia
Switzerland
Netherlands
France
Poland
Greece
Slovakia
Hungary
Belgium
Spain
Turkey
Germany
United Kingdom

location_facility: Middlesex Hospital- Meyerstein Institute

location_facility: Institute of Oncology and Radiology of Serbia

location_facility: Istanbul University-Institute of Oncology

location_facility: Istituti Fisioterapici Ospitalieri - Roma

location_facility: Universidad de Santiago - Hospital de Conxo

location_facility: Centre Hospitalier Regional de la Citadelle

location_facility: Institut Catala d'Oncologia - Hospital Duran i Reynals

location_facility: Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology

location_facility: Centre Hospital Regional Universitaire de Limoges

location_facility: Centro di Riferimento Oncologico - Aviano

location_facility: Hospital Clinico Universitario de Valencia

intervention_type: Radiation


title: INDUCTION WITH ALL-TRANS RETINOIC ACID IN COMBINATION WITH IDARUBICIN AND INTENSIVE CONSOLIDATION FOLLOWED BY BONE MARROW TRANSPLANTATION OR A RANDOMIZED MAINTENANCE TREATMENT DEPENDING UPON THE AMOUNT OF MINIMAL RESIDUAL DISEASE IN ACUTE PROMYELOCYTIC LEUKEMIA

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy to kill tumor cells. It is not yet known which regimen of combination chemotherapy with or without bone marrow transplantation is more effective in treating promyelocytic leukemia

PURPOSE: Randomized phase III trial to compare the effectiveness of different combination chemotherapy regimens with or without bone marrow transplantation in treating patients who have promyelocytic leukemia.

enrollment_type: Anticipated

location_country:
Italy
Austria
Netherlands
Croatia
France
Belgium
Turkey
Germany
Czech Republic

location_facility: Ospedale Gen. Provinciale Santa Maria Goretti

location_facility: Universita Degli Studi di Bari Policlinico

location_facility: Ospedale San Martino/Cliniche Universitarie Convenzionate

location_facility: University Hospital - Rotterdam Dijkzigt

location_facility: Istituto di Ematologia Universita - University di Sassari

location_facility: Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore

status_simplified: Unknown


title: A Phase 3 Randomized Double-blind Trial of Maintenance With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer.

summary:
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study of niraparib as maintenance in platinum sensitive ovarian cancer patients who have either gBRCAmut or a tumor with high-grade serous histology and who have responded to their most recent chemotherapy containing a platinum agent. Niraparib is an orally active PARP inhibitor. Niraparib or placebo (in a 2:1 ratio) will be administered once daily continuously during a 28-day cycle. Health-related quality of life will be measured by the Functional Assessment of Cancer Therapy - Ovarian Symptom Index (FOSI), European Quality of Life scale, 5-Dimensions (EQ-5D), and a neuropathy questionnaire. Safety and tolerability will be assessed by clinical review of adverse events (AEs), physical examinations, electrocardiograms (ECGs), and safety laboratory values.

The primary objective of this study is to evaluate efficacy of niraparib as maintenance therapy in patients who have platinum sensitive ovarian cancer as assessed by the prolongation of progression free survival (PFS).

ReferenceCitation: Mirza MR, Monk BJ, Herrstedt J, Oza AM, Mahner S, Redondo A, Fabbro M, Ledermann JA, Lorusso D, Vergote I, Ben-Baruch NE, Marth C, Mądry R, Christensen RD, Berek JS, Dørum A, Tinker AV, du Bois A, González-Martín A, Follana P, Benigno B, Rosenberg P, Gilbert L, Rimel BJ, Buscema J, Balser JP, Agarwal S, Matulonis UA; ENGOT-OV16/NOVA Investigators. Niraparib Maintenance Therapy in Platinum-Sensitive, Recurrent Ovarian Cancer. N Engl J Med. 2016 Dec 1;375(22):2154-2164. Epub 2016 Oct 7.

ReferenceCitation: Mirza MR, Benigno B, Dørum A, Mahner S, Bessette P, Barceló IB, Berton-Rigaud D, Ledermann JA, Rimel BJ, Herrstedt J, Lau S, du Bois A, Herráez AC, Kalbacher E, Buscema J, Lorusso D, Vergote I, Levy T, Wang P, de Jong FA, Gupta D, Matulonis UA. Long-term safety in patients with recurrent ovarian cancer treated with niraparib versus placebo: Results from the phase III ENGOT-OV16/NOVA trial. Gynecol Oncol. 2020 Nov;159(2):442-448. doi: 10.1016/j.ygyno.2020.09.006. Epub 2020 Sep 25.

family: Mirza

full_name: Mansoor R. Mirza

given: Mansoor R.

family: Benigno

full_name: B. Benigno

given: B.

family: Dørum

full_name: A. Dørum

given: A.

family: Mahner

full_name: S. Mahner

given: S.

family: Bessette

full_name: P. Bessette

given: P.

family: Barceló

full_name: I. Bover Barceló

given: I. Bover

family: Berton-Rigaud

full_name: D. Berton-Rigaud

given: D.

family: Ledermann

full_name: J.A. Ledermann

family: Rimel

full_name: B.J. Rimel

family: Herrstedt

full_name: J. Herrstedt

given: J.

family: Lau

full_name: S. Lau

family: du Bois

full_name: A. du Bois

family: Herráez

full_name: A. Casado Herráez

given: A. Casado

family: Kalbacher

full_name: E. Kalbacher

given: E.

family: Buscema

full_name: J. Buscema

family: Lorusso

full_name: D. Lorusso

family: Vergote

full_name: I. Vergote

given: I.

family: Levy

full_name: T. Levy

given: T.

family: Wang

full_name: P. Wang

family: de Jong

full_name: F.A. de Jong

family: Gupta

full_name: D. Gupta

family: Matulonis

full_name: U.A. Matulonis

journal_name: Gynecologic Oncology

evidence: oa repository (via OAI-PMH title and first author match)

repository_institution: University College London - UCL Discovery

ReferenceCitation: Matulonis UA, Walder L, Nøttrup TJ, Bessette P, Mahner S, Gil-Martin M, Kalbacher E, Ledermann JA, Wenham RM, Woie K, Lau S, Marmé F, Casado Herraez A, Hardy-Bessard AC, Banerjee S, Lindahl G, Benigno B, Buscema J, Travers K, Guy H, Mirza MR. Niraparib Maintenance Treatment Improves Time Without Symptoms or Toxicity (TWiST) Versus Routine Surveillance in Recurrent Ovarian Cancer: A TWiST Analysis of the ENGOT-OV16/NOVA Trial. J Clin Oncol. 2019 Dec 1;37(34):3183-3191. doi: 10.1200/JCO.19.00917. Epub 2019 Sep 16.

name: Dana-Farber Cancer Institute, Boston, MA

name: Nordic Society of Gynaecological Oncology and Copenhagen University Hospital, Copenhagen, Denmark

name: PMHC and University of Sherbrooke, Sherbrooke, Québec, Canada

name: Arbeitsgemeinschaft Gynäkologische Onkologie and University of Munich, Munich, Germany

name: Grupo Español de Investigación en Cáncer de Ovario and Institut Català d’Oncologia-IDIBELL, L’Hospitalet, Barcelona, Spain

name: Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens and University Hospital Besançon, Besançon, France

name: National Cancer Research Institute and University College London Cancer Institute, London, United Kingdom

name: Nordic Society of Gynaecological Oncology and Haukeland University Hospital, Bergen, Norway

name: PMHC and Jewish General Hospital, Montreal, Québec, Canada

name: Arbeitsgemeinschaft Gynäkologische Onkologie and Universitätsklinikum Heidelberg, Heidelberg, Germany

name: Grupo Español de Investigación en Cáncer de Ovario and Hospital Universitario San Carlos, Madrid, Spain

name: Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens and Centre Amoricain D'Oncologie, Paris, France

name: National Cancer Research Institute and The Royal Marsden NHS Foundation Trust and Institute of Cancer Research, London, United Kingdom

name: Nordic Society of Gynaecological Oncology and Linköping University Hospital, Linköping, Sweden

repository_institution: Universitat de Barcelona - Dipòsit Digital de la Universitat de Barcelona

publisher: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Del Campo JM, Matulonis UA, Malander S, Provencher D, Mahner S, Follana P, Waters J, Berek JS, Woie K, Oza AM, Canzler U, Gil-Martin M, Lesoin A, Monk BJ, Lund B, Gilbert L, Wenham RM, Benigno B, Arora S, Hazard SJ, Mirza MR. Niraparib Maintenance Therapy in Patients With Recurrent Ovarian Cancer After a Partial Response to the Last Platinum-Based Chemotherapy in the ENGOT-OV16/NOVA Trial. J Clin Oncol. 2019 Nov 10;37(32):2968-2973. doi: 10.1200/JCO.18.02238. Epub 2019 Jun 7.

name: Grupo Español de Investigación en Cáncer de Ovario (GEICO) and Vall d'Hebrón University Hospital, Barcelona, Spain

name: Nordic Society of Gynaecological Oncology (NSGO) and Lund University Hospital, Lund, Sweden

name: Centre Hospitalier de L’Université de Montréal, Montreal, Quebec, Canada

name: Arbeitsgemeinschaft Gynäkologische Onkologie (AGO) and University Hospital, Ludwig-Maximilians-University Munich, Munich, Germany

name: Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens (GINECO) and Centre Antoine Lacassagne, Nice, France

name: National Cancer Research Institute (NCRI) and Kent Oncology Centre, Maidstone Hospital, Kent, United Kingdom

name: Stanford Women’s Cancer Center, Stanford Cancer Institute, Stanford, CA

name: Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada

name: AGO and Technische Universität Dresden, Dresden, Germany

name: GEICO and Institut Català d’Oncologia-IDIBELL, L’Hospitalet, Barcelona, Spain

name: GINECO and Centre Oscar Lambret, Lille, France

name: Arizona Oncology (US Oncology Network), University of Arizona College of Medicine, Creighton University School of Medicine at St Joseph’s Hospital, Phoenix, AZ

name: NSGO and Aalborg University Hospital, Aalborg, Denmark

name: McGill University, Research Institute, McGill University Health Centre, Montreal, Quebec, Canada

name: H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL

name: NSGO and Rigshospitalet–Copenhagen University Hospital, Copenhagen, Denmark

repository_institution: The University of Arizona - UA Campus Repository

ReferenceCitation: Oza AM, Matulonis UA, Malander S, Hudgens S, Sehouli J, Del Campo JM, Berton-Rigaud D, Banerjee S, Scambia G, Berek JS, Lund B, Tinker AV, Hilpert F, Vázquez IP, D'Hondt V, Benigno B, Provencher D, Buscema J, Agarwal S, Mirza MR. Quality of life in patients with recurrent ovarian cancer treated with niraparib versus placebo (ENGOT-OV16/NOVA): results from a double-blind, phase 3, randomised controlled trial. Lancet Oncol. 2018 Aug;19(8):1117-1125. doi: 10.1016/S1470-2045(18)30333-4. Epub 2018 Jul 17.

ReferenceCitation: Berek JS, Matulonis UA, Peen U, Ghatage P, Mahner S, Redondo A, Lesoin A, Colombo N, Vergote I, Rosengarten O, Ledermann J, Pineda M, Ellard S, Sehouli J, Gonzalez-Martin A, Berton-Rigaud D, Madry R, Reinthaller A, Hazard S, Guo W, Mirza MR. Safety and dose modification for patients receiving niraparib. Ann Oncol. 2018 Aug 1;29(8):1784-1792. doi: 10.1093/annonc/mdy181. Erratum in: Ann Oncol. 2019 May 1;30(5):859.

location_country:
Italy
Austria
United States
Sweden
Germany
France
Poland
Israel
Norway
Hungary
Belgium
Spain
Denmark
Canada
United Kingdom


status: Terminated

lead_sponsor: AstraZeneca

location_country:
Italy
Brazil
Sweden
Germany
France
Poland
Denmark
United States

acronym: ASTRA

source: euctr

title: A Randomised, Double Blind Study to Compare the Complete Remission Rate Following a 5-Week Course of Selumetinib or Placebo and Single Dose Adjuvant Radioactive Iodine Therapy in Patients With Differentiated Thyroid Cancer

summary: The study is designed to evaluate the clinical efficacy, safety and tolerability of selumetinib with radioactive iodine therapy in patients with differentiated thyroid cancer.


title: A Multicenter Retrospective Study on the Prognostic Impact of Pregnancy in Women With History of BRCA Mutated Breast Cancer

summary: The present study aims at refining the understanding of the effect of pregnancy on breast cancer outcomes in the specific population of BRCA mutated patients with known history of breast cancer.

study_type: Observational

time_perspective: Retrospective

ReferenceCitation: Lambertini M, Ameye L, Hamy AS, Zingarello A, Poorvu PD, Carrasco E, Grinshpun A, Han S, Rousset-Jablonski C, Ferrari A, Paluch-Shimon S, Cortesi L, Senechal C, Miolo G, Pogoda K, Pérez-Fidalgo JA, De Marchis L, Ponzone R, Livraghi L, Estevez-Diz MDP, Villarreal-Garza C, Dieci MV, Clatot F, Berlière M, Graffeo R, Teixeira L, Córdoba O, Sonnenblick A, Luna Pais H, Ignatiadis M, Paesmans M, Partridge AH, Caron O, Saule C, Del Mastro L, Peccatori FA, Azim HA Jr. Pregnancy After Breast Cancer in Patients With Germline BRCA Mutations. J Clin Oncol. 2020 Sep 10;38(26):3012-3023. doi: 10.1200/JCO.19.02399. Epub 2020 Jul 16.

name: Department of Internal Medicine and Medical Specialties (DiMI), School of Medicine, University of Genoa, Genoa, Italy

name: Department of Medical Oncology, UOC Clinica di Oncologia Medica, IRCCS Ospedale Policlinico San Martino, Genoa, Italy

family: Lambertini

full_name: Matteo Lambertini

given: Matteo

name: Data Centre, Institut Jules Bordet and Université Libre de Bruxelles, Brussels, Belgium

family: Ameye

full_name: Lieveke Ameye

given: Lieveke

name: Department of Medical Oncology, Institut Curie, Paris, France

family: Hamy

full_name: Anne-Sophie Hamy

given: Anne-Sophie

name: Département Médecine Oncologique, Institut Gustave Roussy, Université Paris-Saclay, Villejuif, France

family: Zingarello

full_name: Anna Zingarello

given: Anna

name: Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA

family: Poorvu

full_name: Philip D. Poorvu

given: Philip D.

name: Hereditary Cancer Genetics Group, Vall d’Hebron Institute of Oncology (VHIO), Hospital Universitari Vall d’Hebron, Vall d’Hebron Barcelona Hospital Campus, Barcelona, Spain

family: Carrasco

full_name: Estela Carrasco

given: Estela

name: Sharett Institute of Oncology, Hadassah-Hebrew University Medical Center, Jerusalem, Israel

family: Grinshpun

full_name: Albert Grinshpun

given: Albert

name: Multidisciplinary Breast Center, Department of Gynaecology, University Hospitals Leuven, Department of Oncology, KU Leuven, Leuven, Belgium

family: Han

full_name: Sileny Han

given: Sileny

name: Department of Surgery, Centre Léon Bérard, Lyon, France

family: Rousset-Jablonski

full_name: Christine Rousset-Jablonski

given: Christine

name: Department of Surgical Sciences, General Surgery III-Breast Surgery, Fondazione IRCCS Policlinico San Matteo, and Department of Clinical Surgical Sciences, University of Pavia, Pavia, Italy

family: Ferrari

full_name: Alberta Ferrari

given: Alberta

name: Breast Oncology Unit, Shaare Zedek Medical Centre, Jerusalem, Israel

family: Paluch-Shimon

full_name: Shani Paluch-Shimon

given: Shani

name: Department of Oncology and Haematology, Azienda Ospedaliero-Universitaria Policlinico di Modena, Modena, Italy

family: Cortesi

full_name: Laura Cortesi

given: Laura

name: Cancer Genetics Unit, Bergonie Institute, Bordeaux, France

family: Senechal

full_name: Claire Senechal

given: Claire

name: Department of Medical Oncology, Centro di Riferimento Oncologico di Aviano, IRCCS, Aviano, Italy

family: Miolo

full_name: Gianmaria Miolo

given: Gianmaria

name: Department of Breast Cancer and Reconstructive Surgery, Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland

family: Pogoda

full_name: Katarzyna Pogoda

given: Katarzyna

name: Department of Medical Oncology, INCLIVA University Hospital of Valencia, CIBERONC, Valencia, Spain

family: Pérez-Fidalgo

full_name: Jose Alejandro Pérez-Fidalgo

given: Jose Alejandro

name: Division of Medical Oncology, Department of Radiological, Oncological and Pathological Sciences, “La Sapienza” University of Rome, Rome, Italy

family: De Marchis

full_name: Laura De Marchis

name: Gynecological Oncology, Candiolo Cancer Institute, FPO–IRCCS, Candiolo, Turin, Italy

family: Ponzone

full_name: Riccardo Ponzone

given: Riccardo

name: Medical Oncology Unit, ASST Papa Giovanni XXIII, Bergamo, Italy

family: Livraghi

full_name: Luca Livraghi

given: Luca

name: Department of Oncology, Instituto do Cancer do Estado de São Paulo–Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil

family: Estevez-Diz

full_name: Maria Del Pilar Estevez-Diz

given: Maria Del Pilar

name: Departamento de Investigacion y de Tumores Mamarios, Instituto Nacional de Cancerologia, Mexico City, Mexico

name: Tecnologico de Monterrey, Centro de Cancer de Mama del Hospital Zambrano Hellion, Nuevo Leon, Mexico

family: Villarreal-Garza

full_name: Cynthia Villarreal-Garza

given: Cynthia

name: Department of Surgery, Oncology and Gastroenterology, University of Padova, Padova, Italy

name: Medical Oncology 2, Istituto Oncologico Veneto IOV-IRCCS, Padova, Italy

family: Dieci

full_name: Maria Vittoria Dieci

given: Maria Vittoria

name: Department of Medical Oncology, Centre Henri Becquerel, Rouen, France

family: Clatot

full_name: Florian Clatot

given: Florian

name: Department of Oncology, Breast Clinic, Cliniques Universitaires Saint-Luc UCL, Brussels, Belgium

family: Berlière

name: Breast Unit of Southern Switzerland, Oncology Institute of Southern Switzerland, Bellinzona, Switzerland

name: Breast Disease Unit Saint-Louis Hospital, APHP, Université de Paris, Inserm, U976 HIPI Unit, F-75010, Paris, France

name: Obstetrics and Gynecology Department, Hospital Universitari Son Espases, Palma, Spain

name: Oncology Division, Tel Aviv Sourasky Medical Center, and Sackler Faculty of Medicine, Tel Aviv, Israel

name: Department of Medical Oncology, Centro Hospitalar Universitário Lisboa Norte–Hospital de Santa Maria, Lisbon, Portugal

name: Department of Medical Oncology, Institut Jules Bordet and Université Libre de, Brussels, Belgium

name: Department of Genetics, Institut Curie, Paris, France

name: Breast Unit, IRCCS Ospedale Policlinico San Martino, Genoa, Italy

name: Gynecologic Oncology Department, European Institute of Oncology IRCCS, Milan, Italy

publisher_dissemination: American Society of Clinical Oncology (ASCO)

location_country:
Italy
Brazil
Switzerland
Mexico
Spain
France
Poland
Israel
Belgium
Portugal
United States

location_facility: Azienda Ospedaliera "Papa Giovanni XXIII"

location_facility: Hospital de Santa Maria and Instituto de Medicina Molecular of the Faculty of Medicine of the University of Lisbon

location_facility: Azienda Ospedaliero-Universitaria Policlinico, University of Modena and Reggio Emilia

location_facility: Sharett Institute of Oncology - Hadassah Hebrew University Medical Center

location_facility: Policlinico San Martino - IRCCS per l'Oncologia

location_facility: INCLIVA, University Hospital of Valencia