A Phase 3 Randomized, Placebo-controlled Trial of Carboplatin and Paclitaxel With or Without Veliparib (ABT-888) in HER2-negative Metastatic or Locally Advanced Unresectable BRCA-associated Breast Cancer

A Phase 3 Randomized, Placebo-Controlled Trial of Carboplatin and Paclitaxel With or Without the PARP Inhibitor Veliparib (ABT-888) in HER2-Negative Metastatic or Locally Advanced Unresectable BRCA-Associated Breast Cancer

The primary objective of the study is to assess the progression-free survival (PFS) of veliparib in combination with carboplatin and paclitaxel (C/P) compared to placebo plus C/P in participants with a Breast Cancer Gene 1 or 2 (BRCA1; BRCA2) mutation in Human Epidermal Growth Factor Receptor 2 (HER2)-negative metastatic or locally advanced unresectable breast cancer. The secondary objectives of the study are to assess overall survival (OS), clinical benefit rate (CBR) through the end of Week 24, objective response rate (ORR) and PFS on subsequent therapy (PFS2) in participants treated with veliparib in combination with C/P versus placebo in combination with C/P.

Study Overview

• Status: Completed
• Conditions: Metastatic Breast Cancer
• Intervention / Treatment: Drug: Veliparib Placebo; Drug: Carboplatin; Drug: Paclitaxel; Drug: Veliparib

Detailed Description

This is a Phase 3, randomized, double-blind, multinational, multicenter study to evaluate the efficacy and tolerability of veliparib in combination with C/P compared to placebo in combination with C/P in participants with a BRCA1 or BRCA2 mutation, as documented by the Sponsor core laboratory, with HER2-negative metastatic or locally advanced unresectable breast cancer who received no more than 2 prior lines of cytotoxic therapy for metastatic disease. For the purposes of eligibility, HER2-negative status was based on the most recent tumor biopsy. Participants were randomized in a 2:1 ratio, with a total of approximately 500 participants planned to be randomized. Veliparib 120 mg/placebo twice a day (BID) was dosed Days -2 through 5 with carboplatin target area under the concentration-time curve (AUC) 6 administered on Day 1 and paclitaxel 80 mg/m2 administered weekly on Days 1, 8, and 15 of each 21-day cycle.

Safety and efficacy data through the prespecified primary analysis cutoff date of 05 April 2019 are included in the interim analysis.

• Study Type: Interventional
• Enrollment (Actual): 513
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • La Rioja, Argentina, 5300
    • Centro Oncologico Riojano Integral /ID# 127938
  • Buenos Aires
    • Berazategui, Buenos Aires, Argentina, 1884
      • COIBA Centro de Oncologia e Investigacion de Buenos Aires /ID# 124839
    • Pergamino, Buenos Aires, Argentina, 2700
      • Clinica Pergamino /ID# 127158
  • Santa Fe
    • Rosario, Santa Fe, Argentina, 2000
      • Instituto de Oncoloia de Rosario /ID# 127157
• Australia
  • New South Wales
    • Kogarah, New South Wales, Australia, 2217
      • St George Hospital /ID# 129416
    • Randwick, New South Wales, Australia, 2031
      • Duplicate_The Prince of Wales Hospital /ID# 124845
    • Wollongong, New South Wales, Australia, 2500
      • Southern Medical Day Care Centre /ID# 124844
  • Queensland
    • Douglas, Queensland, Australia, 4814
      • Townsville University Hospital /ID# 126731
  • South Australia
    • Bedford Park, South Australia, Australia, 5042
      • Duplicate_Flinders Centre for Innovation /ID# 127535
  • Tasmania
    • Hobart, Tasmania, Australia, 7000
      • Royal Hobart Hospital /ID# 124849
  • Victoria
    • Parkville, Victoria, Australia, 3050
      • The Royal Melbourne Hospital /ID# 124846
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Hollywood Private Hospital /ID# 124843
• Austria
  • Salzburg, Austria, 5020
    • Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 126449
  • Oberoesterreich
    • Linz, Oberoesterreich, Austria, 4010
      • Ordensklinikum Linz GmbH Elisabethinen /ID# 126185
  • Steiermark
    • Graz, Steiermark, Austria, 8036
      • Medizinische Universitaet Graz /ID# 126450
  • Wien
    • Vienna, Wien, Austria, 1090
      • Medizinische Universitaet Wien /ID# 126184
• Belarus
  • Bobruisk, Belarus, 213825
    • Bobruysk Interdistrict Onco. /ID# 137729
  • Minsk, Belarus, 223040
    • State Institution Republican Scientific Practical Center of Oncology and Medical /ID# 125223
  • Mogilev, Belarus, 212018
    • Duplicate_Mogilev Reg Clin Oncology Dis /ID# 137728
  • Vitebsk, Belarus, 210603
    • Vitebsk Regional Clinical Oncology Dispensary /ID# 125219
• Belgium
  • Antwerp, Belgium, 2020
    • ZNA Middelheim /ID# 124978
  • Namur, Belgium, 5000
    • CHU UCL Namur - Sainte Elisabeth /ID# 124979
  • Antwerpen
    • Edegem, Antwerpen, Belgium, 2650
      • Universitair Ziekenhuis Antwerpen /ID# 124977
  • Bruxelles-Capitale
    • Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200
      • UCL Saint-Luc /ID# 124976
  • Hainaut
    • Charleroi, Hainaut, Belgium, 6000
      • Grand Hôpital de Charleroi /ID# 124981
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • Universitair Ziekenhuis Leuven /ID# 124980
  • West-Vlaanderen
    • Brugge, West-Vlaanderen, Belgium, 8000
      • Duplicate_AZ St-Jan Brugge-Oostende AV /ID# 124975
• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • Duplicate_Sunnybrook Health Sciences Ctr /ID# 124882
  • Quebec
    • Montreal, Quebec, Canada, H3T 1E2
      • Duplicate_Jewish General Hospital /ID# 124880
    • Montréal, Quebec, Canada, H2X 0A9
      • CHUM - Notre-Dame Hospital /ID# 124879
    • Quebec City, Quebec, Canada, G1S 4L8
      • Duplicate_CHUQ-Hospital St. Sacrement /ID# 124881
• Chile
  • Santiago, Chile, 8380455
    • Instituto Nacional del Cancer /ID# 129343
  • Temuco, Chile, 4810469
    • ICOS - Inst Clinic Oncology /ID# 125236
  • Valparaíso
    • Vina Del Mar, Valparaíso, Chile, 2520612
      • Hospital Clinico Vina del Mar /ID# 130100
    • Vina Del Mar, Valparaíso, Chile, 2520612
      • Hospital Clinico Vina del Mar /ID# 148502
• Colombia
  • Cali, Colombia
    • Centro Medico Imbanaco de Cali /ID# 126656
  • Antioquia
    • Medellín, Antioquia, Colombia, 50034
      • Hospital Pablo Tobon Uribe /ID# 126657
  • Cordoba
    • Monteria, Cordoba, Colombia, 230002
      • Instituto Medico de Alta Tecnologia Oncomédica S.A /ID# 129211
  • Cundinamarca
    • Bogota, Cundinamarca, Colombia, 110221
      • Administradora del Country_S.A-Clinica Del Country /ID# 125255
    • Bogota, Cundinamarca, Colombia, 110231
      • Hospital Univ San Ignacio /ID# 126655
• Czechia
  • Brno, Czechia, 625 00
    • Fakultni Nemocnice Brno /ID# 128176
  • Brno, Czechia, 656 53
    • Masarykuv onkologicky ustav /ID# 124886
  • Hradec Kralove, Czechia, 500 05
    • Duplicate_FN Hradec Kralove /ID# 127080
  • Olomouc, Czechia, 779 00
    • Fakultni nemocnice Olomouc /ID# 124885
  • Praha, Czechia, 128 08
    • Vseobecna fakultni nemocnice v Praze /ID# 124887
• Denmark
  • Hovedstaden
    • Copenhagen Ø, Hovedstaden, Denmark, 2100
      • Rigshospitalet /ID# 124891
  • Syddanmark
    • Vejle, Syddanmark, Denmark, 7100
      • Sygehus Lillebælt, Vejle /ID# 124892
• Estonia
  • Harjumaa
    • Kesklinna Linnaosa, Harjumaa, Estonia, 10138
      • East Tallinn Central Hospital /ID# 126475
• Finland
  • Helsinki, Finland, 00180
    • Docrates Cancer Center /ID# 124896
  • Helsinki, Finland, 00290
    • Duplicate_Helsinki Univ Central Hospital /ID# 124897
  • Tampere, Finland, 33521
    • Duplicate_Tampere University Hospital /ID# 124898
  • Vaasa, Finland, 65130
    • Vaasa Central Hospital /ID# 132548
• France
  • Saint-cloud, France, 92210
    • Institut Curie - site CLCC René Huguenin /ID# 124904
  • Bouches-du-Rhone
    • Marseille, Bouches-du-Rhone, France, 13009
      • Institut Paoli-Calmettes /ID# 124903
  • Ile-de-France
    • Paris CEDEX 05, Ile-de-France, France, 75248
      • Institut Curie /ID# 124902
  • Loire-Atlantique
    • St Herblain CEDEX, Loire-Atlantique, France, 44805
      • Institut de Cancérologie de l'Ouest René Gauducheau /ID# 137726
• Germany
  • Dresden, Germany, 01307
    • Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 127180
  • Munich, Germany, 81675
    • Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 125256
  • Offenbach am Main, Germany, 63069
    • Sana Klinikum Offenbach /ID# 126733
  • Baden-Wuerttemberg
    • Heidelberg, Baden-Wuerttemberg, Germany, 69120
      • Universitaetsklinik Heidelberg /ID# 126664
    • Tubingen, Baden-Wuerttemberg, Germany, 72076
      • Universitaetsklinimum Tuebingen /ID# 129968
    • Ulm, Baden-Wuerttemberg, Germany, 89081
      • Universitaetsklinikum Ulm /ID# 135230
  • Nordrhein-Westfalen
    • Köln, Nordrhein-Westfalen, Germany, 50937
      • Universitaetsklinikum Koeln /ID# 126905
• Hungary
  • Budapest, Hungary, 1085
    • Semmelweis Egyetem /ID# 132485
  • Pecs, Hungary, 7624
    • Pecsi Tudomanyegyetem Klinikai Kozpont /ID# 125259
  • Szolnok, Hungary, 5000
    • Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz /ID# 124911
  • Zalaegerszeg, Hungary, 8900
    • Duplicate_Zala Megyei Korhaz /ID# 131341
• Israel
  • Be'Er Ya'Akov, Israel, 70300
    • Assaf Harofeh Medical Center /ID# 124915
  • Be'er Sheva, Israel, 8457101
    • Duplicate_Soroka University Medical Center /ID# 124917
  • Haifa, Israel, 3109601
    • Rambam Health Care Campus /ID# 124916
  • Jerusalem, Israel, 91031
    • Shaare Zedek Medical Center /ID# 130275
  • Jerusalem, Israel, 91120
    • Gastroenterology Institute, Division of Medicine /ID# 124919
  • Rehovot, Israel, 7661041
    • Kaplan Medical Center /ID# 124914
  • Tel-Aviv
    • Ramat Gan, Tel-Aviv, Israel, 5265601
      • The Chaim Sheba Medical Center /ID# 124918
    • Tel Aviv-Yafo, Tel-Aviv, Israel, 6423906
      • Tel Aviv Sourasky Medical Center /ID# 130276
• Italy
  • Aviano, Italy, 33081
    • Centro di Riferimento Oncologico /ID# 126738
  • Reggio Calabria, Italy, 89124
    • Grande Ospedale Metropolitano Bianchi Melacrino Morelli /ID# 125263
  • Lombardia
    • Milan, Lombardia, Italy, 20132
      • Ospedale San Raffaele IRCCS /ID# 125261
  • Milano
    • Milan, Milano, Italy, 20141
      • IEO -Istituto Europeo di Oncologia /ID# 125260
  • Verona
    • Negrar, Verona, Italy, 37024
      • IRCCS Ospedale Sacro Cuore Don Calabria /ID# 125262
• Korea, Republic of
  • Seoul, Korea, Republic of, 02841
    • Korea University Anam Hospital /ID# 128968
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital /ID# 125600
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center /ID# 125601
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center /ID# 125598
  • Gyeonggido
    • Goyang, Gyeonggido, Korea, Republic of, 10408
      • National Cancer Center /ID# 125602
  • Seoul Teugbyeolsi
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03722
      • Yonsei University Health System Severance Hospital /ID# 125599
• Latvia
  • Riga, Latvia, 1002
    • Pauls Stradins Clinical University Hospital /ID# 125264
  • Riga, Latvia, LV-1079
    • Riga East Clinical University Hospital /ID# 125265
• Lithuania
  • Kaunas, Lithuania, 50161
    • Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 125266
  • Vilnius, Lithuania, 08660
    • National Cancer Institute /ID# 125267
• Mexico
  • Chihuahua, Mexico, 31217
    • Centro Oncologico de Chihuahua /ID# 128679
  • Ciudad de Mexico, Mexico, 14080
    • Instituto Nacional de Cancerología INCAN /ID# 128676
  • Yucatan
    • Mérida, Yucatan, Mexico, 97133
      • Centro de Estudios Clínicos Especializados /ID# 128680
• Netherlands
  • Groningen, Netherlands, 9713 GZ
    • Universitair Medisch Centrum Groningen /ID# 129069
  • Maastricht, Netherlands, 6229 HX
    • Maastricht Universitair Medisch Centrum /ID# 129068
  • Zuid-Holland
    • Rotterdam, Zuid-Holland, Netherlands, 3015 GD
      • Erasmus Medisch Centrum /ID# 124935
• Norway
  • Hordaland
    • Bergen, Hordaland, Norway, 5021
      • Haukeland University Hospital /ID# 150177
• Poland
  • Dolnoslaskie
    • Wroclaw, Dolnoslaskie, Poland, 51-124
      • Wojewodzki Szpital Specjalistyczny /ID# 127258
  • Kujawsko-pomorskie
    • Bydgoszcz, Kujawsko-pomorskie, Poland, 85-796
      • Centrum Onkologii Lukaszczyka /ID# 124938
  • Lodzkie
    • Lodz, Lodzkie, Poland, 93-513
      • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopern /ID# 126999
  • Podkarpackie
    • Rzeszow, Podkarpackie, Poland, 35-021
      • MRUK-MED I Spolka z ograniczona odpowiedzialnoscia /ID# 124939
  • Warminsko-mazurskie
    • Elblag, Warminsko-mazurskie, Poland, 82-300
      • Wojewodzki Szpital Zespolony /ID# 126998
• Portugal
  • Faro, Portugal, 8000-386
    • Centro Hospitalar Universitário do Algarve, EPE - Hospital Faro /ID# 125298
  • Lisboa, Portugal, 1649-035
    • Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 125299
  • Matosinhos, Portugal, 4464-513
    • Unidade Local de Saúde de Matosinhos, EPE /ID# 126511
  • Porto, Portugal, 4200-072
    • IPO Porto FG, EPE /ID# 125297
  • Porto, Portugal, 4200-319
    • Centro Hospitalar Universitario de Sao Joao, EPE /ID# 126508
  • Porto
    • Vila Nova De Gaia, Porto, Portugal, 4434-502
      • Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE /ID# 126510
• Puerto Rico
  • Ponce, Puerto Rico, 00717
    • Ad-Vance Medical Research, LLC /ID# 126043
  • San Juan, Puerto Rico, 00935
    • San Juan Municipal Hospital /ID# 124695
• Romania
  • Bucharest, Romania, 022328
    • Duplicate_lnstitutul Oncologic Prof Dr Alexandru Trestioreanu /ID# 124943
  • Cluj-Napoca, Romania, 400006
    • Spitalul Clinic Judetean de Urgenta Cluj -Napoca /ID# 124945
  • Timisoara, Romania, 300239
    • Oncomed SRL /ID# 127598
  • Dolj
    • Craiova, Dolj, Romania, 200347
      • S.C. Centrul de Oncologie Sf. Nectarie S.R.L. /ID# 124948
• Russian Federation
  • Arkhangelsk, Russian Federation, 163045
    • Duplicate_archangel Clinical Oncology /ID# 126031
  • Barnaul, Russian Federation, 656049
    • Altay Regional Oncological Dispesary /ID# 127160
  • Belgorod, Russian Federation, 308010
    • Belgorod Oncology Dispensary /ID# 129315
  • Saratov, Russian Federation, 410012
    • Duplicate_Saratov State Medical University n.s. Chernyshevskiy /ID# 139395
  • St. Petersburg, Russian Federation, 197342
    • LLC BioEq Ltd. /ID# 134529
  • Tomsk, Russian Federation, 634050
    • Siberian State Medical University /ID# 127161
  • Volzhsky, Russian Federation, 404130
    • Volgograd Regional Clinical Oncology Dispensary /ID# 124952
  • Sverdlovskaya Oblast
    • Yekaterinburg, Sverdlovskaya Oblast, Russian Federation, 620043
      • Sverdlovsk Regional Oncology Dispensary /ID# 130950
  • Tatarstan, Respublika
    • Kursk, Tatarstan, Respublika, Russian Federation, 305035
      • Regional Oncology Dispensary /ID# 125936
• Singapore
  • Singapore, Singapore, 119074
    • National University Hospital /ID# 125315
  • Singapore, Singapore, 308433
    • Johns Hopkins Singapore IMC /ID# 125316
• South Africa
  • Eastern Cape
    • Gqeberha, Eastern Cape, South Africa, 6006
      • GVI Oncology /ID# 125321
  • Free State
    • Bloemfontein, Free State, South Africa, 9301
      • University of Free State, Universitas Annex (National Hospital Grounds) /ID# 128499
  • Gauteng
    • Johannesburg, Gauteng, South Africa, 2193
      • Wits Clinical Research Site /ID# 125317
    • Johannesburg, Gauteng, South Africa, 2196
      • Medical Oncology Ctr Rosebank /ID# 125322
    • Johannesburg, Gauteng, South Africa, 2196
      • Sandton Oncology Medical Group PTY Ltd /ID# 125323
    • Pretoria, Gauteng, South Africa, 0181
      • Mary Potter Oncology Centre /ID# 133269
  • Kwazulu-Natal
    • Durban, Kwazulu-Natal, South Africa, 4091
      • The Oncology Centre /ID# 126104
  • Western Cape
    • Cape Town, Western Cape, South Africa, 7460
      • Netcare Oncology Intervent Ctr /ID# 125320
    • George, Western Cape, South Africa, 6530
      • Cancercare Outeniqua Oncology Centre /ID# 125319
• Spain
  • Barcelona, Spain, 08041
    • Hospital Santa Creu i Sant Pau /ID# 124963
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Maranon /ID# 124962
  • Madrid, Spain, 28050
    • Hospital Universitario HM Sanchinarro /ID# 124960
  • Malaga, Spain, 29010
    • Hospital Universitario Virgen de la Victoria /ID# 124961
  • Valencia, Spain, 46010
    • Hospital Clinico Universitario de Valencia /ID# 124959
• Sweden
  • Linkoping, Sweden, 581 85
    • Linkoping University Hospital /ID# 126795
  • Solna, Sweden, 171 64
    • Duplicate_Karolinska Univ Sjukhuset /ID# 124964
  • Uppsala, Sweden, 75185
    • Uppsala University Hospital /ID# 126512
  • Skane Lan
    • Malmo, Skane Lan, Sweden, 214 28
      • Skane University hospital /ID# 124966
  • Vasterbottens Lan
    • Umea, Vasterbottens Lan, Sweden, 581 85
      • Norrlands University hospital /ID# 124967
  • Vastra Gotalands Lan
    • Gothenburg, Vastra Gotalands Lan, Sweden, 413 45
      • Sahlgrenska University Hospital /ID# 124965
• Taiwan
  • Kaohsiung, Taiwan, 807
    • Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 125575
  • Taipei City, Taiwan, 100
    • National Taiwan University Hospital /ID# 125324
• Turkey
  • Ankara, Turkey, 06100
    • Hacettepe University Faculty of Medicine /ID# 125336
  • Ankara, Turkey, 06200
    • Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi /ID# 125337
  • Antalya, Turkey, 07059
    • Duplicate_Akdeniz University Medical Fac /ID# 125339
  • Istanbul, Turkey, 34093
    • Bezmi Alem Univ Med Fac Hosp /ID# 127901
  • Istanbul, Turkey, 34093
    • Istanbul University Istanbul Medical Faculty /ID# 145144
• Ukraine
  • Dnipro, Ukraine, 49102
    • Municipal Non-Profit Enterprise City Clinical Hospital No.4 of Dnipro City Counc /ID# 124968
  • Donetsk, Ukraine, 83092
    • Donetsk Regional Antitumor Ctr /ID# 124970
  • Kharkiv, Ukraine, 61070
    • Communal non-profit enterprise Regional Center of Oncology /ID# 124972
  • Lviv, Ukraine, 79031
    • Lviv Oncological Regional Therapeutical and Diagnostic Centre /ID# 124974
  • Poltava, Ukraine, 36011
    • Poltava Regional Clinical Oncology Centre of Poltava Regional Council /ID# 124969
  • Zaporizhia, Ukraine, 69040
    • Zaporizhzhia Med. Academy MOH /ID# 129800
  • Кривий Ріг, Ukraine, 50048
    • ME Kryviy Rih Oncology Dispensary /ID# 129806
• United Kingdom
  • Birmingham, United Kingdom, B15 2TH
    • University Hospitals Birmingham NHS Foundation Trust /ID# 125342
  • Bristol, City Of
    • Bristol, Bristol, City Of, United Kingdom, BS2 8ED
      • University Hospitals Bristol /ID# 128343
  • East Riding Of Yorkshire
    • Hull, East Riding Of Yorkshire, United Kingdom, HU3 2JZ
      • Hull University Teaching Hospitals NHS Trust /ID# 133030
  • Nottinghamshire
    • Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
      • Nottingham University Hospitals NHS Trust /ID# 125340
• United States
  • Arizona
    • Gilbert, Arizona, United States, 85234
      • Banner MD Anderson Cancer Ctr /ID# 125011
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas for Medical Sciences /ID# 124992
  • California
    • Duarte, California, United States, 91010
      • City of Hope /ID# 127117
    • Fresno, California, United States, 93720
      • California Cancer Associates for Research & Excellence (cCARE) /ID# 136078
    • La Jolla, California, United States, 92093
      • Moores Cancer Center at UC San Diego /ID# 124991
    • Newport Beach, California, United States, 92663
      • Hematology and Oncology Assoc /ID# 130058
    • Santa Ana, California, United States, 92705
      • Cancer Research Collaboration /ID# 128860
    • Whittier, California, United States, 90603
      • Icri /Id# 128520
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Univ of Colorado Cancer Center /ID# 124983
    • Denver, Colorado, United States, 80218
      • Saint Joseph Hospital /ID# 131768
  • Connecticut
    • Norwalk, Connecticut, United States, 06856
      • Norwalk Hospital /ID# 133509
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Lynn Cancer Institute, Boca /ID# 125013
    • Fort Lauderdale, Florida, United States, 33308
      • Holy Cross Hospital /ID# 125012
    • Pensacola, Florida, United States, 32504
      • Sacred Heart Hospital /ID# 128279
    • Tampa, Florida, United States, 33612-9416
      • Moffitt Cancer Center /ID# 124990
    • West Palm Beach, Florida, United States, 33401
      • Florida Cancer Specialists - East /ID# 125007
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory Midtown Infectious Disease Clinic /ID# 133192
    • Decatur, Georgia, United States, 30033
      • The Cancer Ctr at DeKalb Med C /ID# 125024
  • Illinois
    • Chicago, Illinois, United States, 60607
      • University of Illinois - Chicago /ID# 127576
    • Evanston, Illinois, United States, 60201
      • NorthShore University HealthSystem /ID# 124996
    • Zion, Illinois, United States, 60099
      • Midwestern Regional CTC /ID# 124986
  • Iowa
    • Ames, Iowa, United States, 50010
      • McFarland Clinic, PC /ID# 129904
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University /ID# 125015
  • Massachusetts
    • Springfield, Massachusetts, United States, 01199
      • Baystate Medical Center /ID# 139461
    • Worcester, Massachusetts, United States, 01655
      • UMass Chan Medical School /ID# 129067
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System /ID# 134497
    • Grand Rapids, Michigan, United States, 49503
      • Spectrum Health Medical Group /ID# 133568
    • Grand Rapids, Michigan, United States, 49503
      • Spectrum Health Medical Group /ID# 148471
    • Royal Oak, Michigan, United States, 48073-6710
      • William Beaumont Hospital /ID# 125019
  • Mississippi
    • Jackson, Mississippi, United States, 39216-4643
      • Univ of Mississippi Med Ctr,US /ID# 131352
  • Missouri
    • Kansas City, Missouri, United States, 64111-5905
      • St. Lukes Cancer Institute /ID# 125023
    • Saint Louis, Missouri, United States, 63110
      • Washington University-School of Medicine /ID# 127575
  • Nebraska
    • Lincoln, Nebraska, United States, 68506
      • Nebraska Hematology Oncology /ID# 132711
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Rutgers Cancer Institute of New Jersey /ID# 125017
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102-4517
      • University of New Mexico /ID# 125349
  • New York
    • New York, New York, United States, 10003
      • Beth Israel Medical Center /ID# 125001
    • New York, New York, United States, 10025
      • Mount Sinai St. Luke's /ID# 125003
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • Mission Cancer Center /ID# 134248
    • Durham, North Carolina, United States, 27710-3000
      • Duke Cancer Center /ID# 124999
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University /ID# 125022
    • Toledo, Ohio, United States, 43614
      • University of Toledo /ID# 134849
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University /ID# 134229
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • Lehigh Valley Health Network /ID# 130059
    • Bethlehem, Pennsylvania, United States, 18017
      • Lehigh Valley Hosp/Muhlenberg /ID# 130277
    • Hershey, Pennsylvania, United States, 17033
      • Penn State University and Milton S. Hershey Medical Center /ID# 124997
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny General Hospital /ID# 135094
    • Pittsburgh, Pennsylvania, United States, 15260
      • University of Pittsburgh MC /ID# 125005
  • Texas
    • Arlington, Texas, United States, 76012
      • Texas Health Physicians Group /ID# 137740
    • Dallas, Texas, United States, 75390-7208
      • University of Texas Southwestern Medical Center /ID# 124989
    • Houston, Texas, United States, 77030
      • University of Texas MD Anderson Cancer Center /ID# 125353
  • Vermont
    • Burlington, Vermont, United States, 05401-1473
      • University of Vermont Medical Center /ID# 125350
  • Washington
    • Issaquah, Washington, United States, 98029-6201
      • Swedish Cancer Institute - Issaquah /ID# 131534
    • Seattle, Washington, United States, 98104
      • Swedish Cancer Institute - Edmonds /ID# 131549
    • Seattle, Washington, United States, 98104
      • Swedish Medical Center /ID# 125021
    • Seattle, Washington, United States, 98107-3932
      • Swedish Cancer Insititute - Ballard /ID# 131548
    • Tacoma, Washington, United States, 98405
      • Northwest Medical Specialties - Tacoma /ID# 125344

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Histologically or cytologically confirmed breast cancer that is either locally advanced or metastatic. Locally advanced breast cancer must not be amenable to surgical resection or radiation with curative intent.
2. Suspected deleterious or deleterious Breast Cancer Gene 1 (BRCA1) and/or Breast Cancer Gene 2 (BRCA2) germline mutation.
3. Breast cancer must be Human Epidermal Growth Factor Receptor 2 (HER2)-negative.
4. Measurable or non-measurable (but radiologically evaluable) disease per Response Evaluation Criteria In Solid Tumors (RECIST), version 1.1 on computed tomography (CT) scan (within 28 days of randomization) with at least one lesion outside previously irradiated areas.
5. Eastern Cooperative Oncology Group (ECOG) Performance status of 0 to 2.
6. Adequate hematologic, renal, and hepatic function (within 28 days of randomization).

Exclusion Criteria:

1. More than two prior lines of cytotoxic chemotherapy (e.g., gemcitabine, doxorubicin, capecitabine) for metastatic disease.

   • Regimens received in the adjuvant/neoadjuvant setting or for locally advanced breast cancer within the past 6 months will also be considered toward the maximum of 2 prior lines of therapy. Adjuvant/neoadjuvant chemotherapy for one cancer event will count as one prior line of therapy, if received within the past 6 months.
   • Previous treatments with hormonal therapy (tamoxifen, aromatase inhibitors) and signal transduction agents (e.g., erlotinib, gefitinib, everolimus, bevacizumab) are allowed and are not counted towards the prior line of therapy.
2. Progressed or recurred within 12 months of completing platinum therapy or received > 1 prior line of platinum therapy for breast cancer in any setting (adjuvant, neoadjuvant, or metastatic).
3. Prior therapy with Poly(ADP-ribose)-Polymerase (PARP) inhibitors.

4. Prior taxane therapy administered for the treatment of metastatic breast cancer with the below exceptions.

   • Prior taxane therapy for metastatic breast cancer is allowed if the patient received ≤ 1 full cycle (i.e., therapy discontinued within 4 weeks for subjects receiving weekly paclitaxel or Abraxane; therapy discontinued within 3 weeks for subjects receiving paclitaxel or docetaxel every 3 weeks) in the absence of progression or if taxane therapy for metastatic disease was > 12 months prior to Cycle 1 Day-2 (C1D-2).
   • Use of taxanes as adjuvant therapy or to treat locally advanced disease is permitted, if given more than 6 months prior to C1D-2
5. Known history of allergic reaction to cremophor-paclitaxel, carboplatin, Azo-Colourant Tartrazine (also known as FD&C Yellow 5 or E102), Azo-Colourant Orange Yellow-S (also known as FD&C Yellow 6 or E110) or known contraindications to any study supplied drug.
6. Active CNS metastases or leptomeningeal disease.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Veliparib Placebo with Carboplatin and Paclitaxel; Placebo capsules for veliparib (120 mg) administered by mouth twice daily (BID) on Days -2 through 5 of a 21-day cycle. Carboplatin administered intravenously over approximately 15 to 30 minutes at AUC 6 mg/ml/min immediately following paclitaxel infusion on Day 1 of every cycle. Paclitaxel administered intravenously over approximately 1 hour at a dose of 80 mg/m² on Days 1, 8, and 15 of every cycle.	Drug: Veliparib Placebo; Supplied as 40 mg, 50 mg, or 100 mg capsules for oral administration twice daily (BID) on Days -2 through 5 of a 21-day cycle.; Drug: Carboplatin; Administered intravenously over approximately 15 to 30 minutes at an area under the curve (AUC) of 6 mg/mL/min immediately following paclitaxel infusion on Day 1 of every cycle. The duration of carboplatin infusion may be lengthened according to institutional guidelines.; Drug: Paclitaxel; Administered by intravenous infusion over approximately 1 hour at a dose of 80 mg/m² of body-surface area (BSA) on Days 1, 8, and 15 of each 21-day cycle. Paclitaxel is to be infused prior to carboplatin on Day 1. Dosing of veliparib/placebo is to be completed before the carboplatin or paclitaxel infusions.
Experimental: Veliparib with Carboplatin and Paclitaxel; Veliparib capsules (120 mg) administered by mouth twice daily (BID) on Days -2 through 5 of a 21-day cycle. Carboplatin administered intravenously over approximately 15 to 30 minutes at AUC 6 mg/ml/min immediately following paclitaxel infusion on Day 1 of every cycle. Paclitaxel administered intravenously over approximately 1 hour at a dose of 80 mg/m² on Days 1, 8, and 15 of every cycle.	Drug: Carboplatin; Administered intravenously over approximately 15 to 30 minutes at an area under the curve (AUC) of 6 mg/mL/min immediately following paclitaxel infusion on Day 1 of every cycle. The duration of carboplatin infusion may be lengthened according to institutional guidelines.; Drug: Paclitaxel; Administered by intravenous infusion over approximately 1 hour at a dose of 80 mg/m² of body-surface area (BSA) on Days 1, 8, and 15 of each 21-day cycle. Paclitaxel is to be infused prior to carboplatin on Day 1. Dosing of veliparib/placebo is to be completed before the carboplatin or paclitaxel infusions.; Drug: Veliparib; Supplied as 40 mg, 50 mg, or 100 mg capsules for oral administration twice daily (BID) on Days -2 through 5 of a 21-day cycle.; Other Names: ABT-888

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival (PFS)	Time to PFS is defined as the number of days from the date the participant was randomized to the date the participant experiences radiographic disease progression (as determined by the investigators), or to the date of death (all causes of mortality) if disease progression is not reached. All events of disease progression occurring on or before the Primary Analysis Cutoff date of 05 April 2019 were to be included, regardless of whether the event occurred while the participant was still taking study drug or had previously discontinued study drug. PFS was estimated for each treatment group using Kaplan-Meier methodology.	From randomization until the primary analysis data cut-off date of 05 April 2019; the median duration of follow-up was 35.5 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR)	The objective response rate (ORR) is calculated as the percentage of participants who have a confirmed partial response (PR) or complete response (CR) based on assessment by the investigators per Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1. All participants who had at least one measurable lesion at baseline were to be included in the ORR calculation. The final analysis of ORR will occur when the pre-specified number of Overall Survival events have occurred in the ITT population, per the fixed sequence testing procedure.	Approximately 8 years from randomization
Progression-Free Survival on Subsequent Therapy (PFS2)	PFS2 is defined as the number of days from the date of randomization to the time of disease progression on subsequent therapy or death from any cause. The distribution of PFS2 was to be estimated for each treatment group using Kaplan-Meier methodology. The final analysis of PFS2 will occur when the pre-specified number of Overall Survival events have occurred in the ITT population, per the fixed sequence testing procedure.	Approximately 8 years from randomization
Overall Survival (OS)	Time to death (overall survival) is defined as the number of days from the date the participant was randomized to the date of the participant's death. All events of death which occur up to the analysis cutoff date are to be included, regardless of whether the event occurred while the participant was still taking study drug or after the participant discontinued study drug. If a participant has not died, the data for the participant is to be censored at the date last known to be alive or at the analysis cutoff date if that is earlier. The final analysis of OS will occur when the pre-specified number of events has occurred in the ITT population.	Up to 84.5 and 81.8 months for Placebo and Veliparib, respectively.
Clinical Benefit Rate (CBR)	The clinical benefit rate (CBR) is defined as the progression-free rate at 24 weeks (168 days), estimated using Kaplan Meier methodology. All events of disease progression in the primary progression free survival analysis database were to be included, regardless of whether the event occurred while the participant was still taking, or had previously discontinued, study drug. If the participant had not yet progressed then their data was to be censored at the date of the last evaluable disease progression assessment. Participants without post-baseline assessments were to be censored at the date of randomization.	Through the end of Week 24

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

General Publications

• Stodtmann S, Eckert D, Joshi R, Nuthalapati S, Ratajczak CK, Menon R, Mensing S, Xiong H. Exposure-Response Model With Time-Varying Predictors to Estimate the Effects of Veliparib in Combination With Carboplatin/Paclitaxel and as Monotherapy: Veliparib Phase 3 Study in BRCA-Mutated Advanced Breast Cancer (BROCADE3) Trial. J Clin Pharmacol. 2022 Oct;62(10):1236-1246. doi: 10.1002/jcph.2061. Epub 2022 May 5.
• Ayoub JP, Wildiers H, Friedlander M, Arun BK, Han HS, Puhalla S, Shparyk Y, Jakobsen EH, Wu M, Bach BA, Feng D, Ratajczak CK, Maag D, Dieras V. Safety and efficacy of veliparib plus carboplatin/paclitaxel in patients with HER2-negative metastatic or locally advanced breast cancer: subgroup analyses by germline BRCA1/2 mutations and hormone receptor status from the phase-3 BROCADE3 trial. Ther Adv Med Oncol. 2021 Dec 9;13:17588359211059601. doi: 10.1177/17588359211059601. eCollection 2021.
• Arun BK, Han HS, Kaufman B, Wildiers H, Friedlander M, Ayoub JP, Puhalla SL, Bell-McGuinn KM, Bach BA, Kundu MG, Ratajczak CK, Maag D, Dieras V. Efficacy and safety of first-line veliparib and carboplatin-paclitaxel in patients with HER2- advanced germline BRCA+ breast cancer: Subgroup analysis of a randomised clinical trial. Eur J Cancer. 2021 Sep;154:35-45. doi: 10.1016/j.ejca.2021.05.037. Epub 2021 Jul 6.
• Puhalla SL, Dieras V, Arun BK, Kaufman B, Wildiers H, Han HS, Ayoub JP, Stearns V, Yuan Y, Helsten T, Riley-Gillis B, Murphy E, Kundu MG, Wu M, Maag D, Ratajczak CK, Ramathal CY, Friedlander M. Relevance of Platinum-free Interval and BRCA Reversion Mutations for Veliparib Monotherapy after Progression on Carboplatin/Paclitaxel for gBRCA Advanced Breast Cancer (BROCADE3 Crossover). Clin Cancer Res. 2021 Sep 15;27(18):4983-4993. doi: 10.1158/1078-0432.CCR-21-0748. Epub 2021 Jun 15.
• Dieras V, Han HS, Kaufman B, Wildiers H, Friedlander M, Ayoub JP, Puhalla SL, Bondarenko I, Campone M, Jakobsen EH, Jalving M, Oprean C, Palacova M, Park YH, Shparyk Y, Yanez E, Khandelwal N, Kundu MG, Dudley M, Ratajczak CK, Maag D, Arun BK. Veliparib with carboplatin and paclitaxel in BRCA-mutated advanced breast cancer (BROCADE3): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2020 Oct;21(10):1269-1282. doi: 10.1016/S1470-2045(20)30447-2. Epub 2020 Aug 27.

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2014
• Primary Completion (Actual): April 5, 2019
• Study Completion (Actual): January 25, 2024

Study Registration Dates

• First Submitted: May 19, 2014
• First Submitted That Met QC Criteria: June 12, 2014
• First Posted (Estimated): June 16, 2014

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 18, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Breast Cancer; ABT-888; PARP Inhibitor; Carboplatin; BRCA2; Metastatic Breast Cancer; Paclitaxel; BRCA1; PARP; Locally recurrent; HER2-negative; Veliparib; BRCA Mutation; Genetic breast cancer; BROCADE3
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms; Poly(ADP-ribose) Polymerase Inhibitors; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Carboplatin; Paclitaxel; Veliparib
• Other Study ID Numbers: M12-914; 2014-000345-70 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
• IPD Sharing Time Frame: For details on when studies are available for sharing, please refer to the link below.
• IPD Sharing Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No