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

PHASE3CompletedINTERVENTIONAL
Enrollment

513

Participants

Timeline

Start Date

April 8, 2014

Primary Completion Date

April 5, 2019

Study Completion Date

January 25, 2024

Conditions
Metastatic Breast Cancer
Interventions
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

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.

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.

Trial Locations (219)

100

National Taiwan University Hospital /ID# 125324, Taipei

807

Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 125575, Kaohsiung City

1002

Pauls Stradins Clinical University Hospital /ID# 125264, Riga

1085

Semmelweis Egyetem /ID# 132485, Budapest

1090

Medizinische Universitaet Wien /ID# 126184, Vienna

1200

UCL Saint-Luc /ID# 124976, Woluwe-Saint-Lambert

1884

COIBA Centro de Oncologia e Investigacion de Buenos Aires /ID# 124839, Berazategui

2000

Instituto de Oncoloia de Rosario /ID# 127157, Rosario

2020

ZNA Middelheim /ID# 124978, Antwerp

2031

Duplicate_The Prince of Wales Hospital /ID# 124845, Randwick

2100

Rigshospitalet /ID# 124891, Copenhagen Ø

2193

Wits Clinical Research Site /ID# 125317, Johannesburg

2196

Medical Oncology Ctr Rosebank /ID# 125322, Johannesburg

Sandton Oncology Medical Group PTY Ltd /ID# 125323, Johannesburg

2217

St George Hospital /ID# 129416, Kogarah

2500

Southern Medical Day Care Centre /ID# 124844, Wollongong

2650

Universitair Ziekenhuis Antwerpen /ID# 124977, Edegem

2700

Clinica Pergamino /ID# 127158, Pergamino

3000

Universitair Ziekenhuis Leuven /ID# 124980, Leuven

3050

The Royal Melbourne Hospital /ID# 124846, Parkville

4010

Ordensklinikum Linz GmbH Elisabethinen /ID# 126185, Linz

4091

The Oncology Centre /ID# 126104, Durban

4814

Townsville University Hospital /ID# 126731, Douglas

5000

CHU UCL Namur - Sainte Elisabeth /ID# 124979, Namur

Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz /ID# 124911, Szolnok

5020

Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 126449, Salzburg

5021

Haukeland University Hospital /ID# 150177, Bergen

5042

Duplicate_Flinders Centre for Innovation /ID# 127535, Bedford Park

5300

Centro Oncologico Riojano Integral /ID# 127938, La Rioja

6000

Grand Hôpital de Charleroi /ID# 124981, Charleroi

6006

GVI Oncology /ID# 125321, Port Elizabeth

6009

Hollywood Private Hospital /ID# 124843, Nedlands

6530

Cancercare Outeniqua Oncology Centre /ID# 125319, George

7000

Royal Hobart Hospital /ID# 124849, Hobart

7100

Sygehus Lillebælt, Vejle /ID# 124892, Vejle

7460

Netcare Oncology Intervent Ctr /ID# 125320, Cape Town

7624

Pecsi Tudomanyegyetem Klinikai Kozpont /ID# 125259, Pécs

8000

Duplicate_AZ St-Jan Brugge-Oostende AV /ID# 124975, Bruges

8036

Medizinische Universitaet Graz /ID# 126450, Graz

8900

Duplicate_Zala Megyei Korhaz /ID# 131341, Zalaegerszeg

9301

University of Free State, Universitas Annex (National Hospital Grounds) /ID# 128499, Bloemfontein

10003

Beth Israel Medical Center /ID# 125001, New York

10025

Mount Sinai St. Luke's /ID# 125003, New York

10138

East Tallinn Central Hospital /ID# 126475, Kesklinn

10408

National Cancer Center /ID# 125602, Goyang

13009

Institut Paoli-Calmettes /ID# 124903, Marseille

14080

Instituto Nacional de Cancerología INCAN /ID# 128676, Mexico City

15212

Allegheny General Hospital /ID# 135094, Pittsburgh

15260

University of Pittsburgh MC /ID# 125005, Pittsburgh

17033

Penn State University and Milton S. Hershey Medical Center /ID# 124997, Hershey

18017

Lehigh Valley Hosp/Muhlenberg /ID# 130277, Bethlehem

18103

Lehigh Valley Health Network /ID# 130059, Allentown

20132

Ospedale San Raffaele IRCCS /ID# 125261, Milan

20141

IEO -Istituto Europeo di Oncologia /ID# 125260, Milan

21287

Johns Hopkins University /ID# 125015, Baltimore

28007

Hospital General Universitario Gregorio Maranon /ID# 124962, Madrid

28050

Hospital Universitario HM Sanchinarro /ID# 124960, Madrid

28801

Mission Cancer Center /ID# 134248, Asheville

29010

Hospital Universitario Virgen de la Victoria /ID# 124961, Málaga

30033

The Cancer Ctr at DeKalb Med C /ID# 125024, Decatur

30322

Emory Midtown Infectious Disease Clinic /ID# 133192, Atlanta

31217

Centro Oncologico de Chihuahua /ID# 128679, Chihuahua City

32504

Sacred Heart Hospital /ID# 128279, Pensacola

33081

Centro di Riferimento Oncologico /ID# 126738, Aviano

33308

Holy Cross Hospital /ID# 125012, Fort Lauderdale

33401

Florida Cancer Specialists - East /ID# 125007, West Palm Beach

33486

Lynn Cancer Institute, Boca /ID# 125013, Boca Raton

33521

Duplicate_Tampere University Hospital /ID# 124898, Tampere

34093

Bezmi Alem Univ Med Fac Hosp /ID# 127901, Istanbul

Istanbul University Istanbul Medical Faculty /ID# 145144, Istanbul

36011

Poltava Regional Clinical Oncology Centre of Poltava Regional Council /ID# 124969, Poltava

37024

IRCCS Ospedale Sacro Cuore Don Calabria /ID# 125262, Negrar

43210

The Ohio State University /ID# 125022, Columbus

43614

University of Toledo /ID# 134849, Toledo

44805

Institut de Cancérologie de l'Ouest René Gauducheau /ID# 137726, Saint-Herblain

46010

Hospital Clinico Universitario de Valencia /ID# 124959, Valencia

48202

Henry Ford Health System /ID# 134497, Detroit

49102

Municipal Non-Profit Enterprise City Clinical Hospital No.4 of Dnipro City Counc /ID# 124968, Dnipro

49503

Spectrum Health Medical Group /ID# 133568, Grand Rapids

Spectrum Health Medical Group /ID# 148471, Grand Rapids

50010

McFarland Clinic, PC /ID# 129904, Ames

50034

Hospital Pablo Tobon Uribe /ID# 126657, Medellín

50048

ME Kryviy Rih Oncology Dispensary /ID# 129806, Kryvyi Rih

50161

Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 125266, Kaunas

50937

Universitaetsklinikum Koeln /ID# 126905, Cologne

60099

Midwestern Regional CTC /ID# 124986, Zion

60201

NorthShore University HealthSystem /ID# 124996, Evanston

60607

University of Illinois - Chicago /ID# 127576, Chicago

61070

Communal non-profit enterprise Regional Center of Oncology /ID# 124972, Kharkiv

63069

Sana Klinikum Offenbach /ID# 126733, Offenbach

63110

Washington University-School of Medicine /ID# 127575, St Louis

65130

Vaasa Central Hospital /ID# 132548, Vaasa

68506

Nebraska Hematology Oncology /ID# 132711, Lincoln

69040

Zaporizhzhia Med. Academy MOH /ID# 129800, Zaporizhia

69120

Universitaetsklinik Heidelberg /ID# 126664, Heidelberg

70300

Assaf Harofeh Medical Center /ID# 124915, Be’er Ya‘aqov

72076

Universitaetsklinimum Tuebingen /ID# 129968, Tübingen

72205

University of Arkansas for Medical Sciences /ID# 124992, Little Rock

75185

Uppsala University Hospital /ID# 126512, Uppsala

75248

Institut Curie /ID# 124902, Paris

76012

Texas Health Physicians Group /ID# 137740, Arlington

77030

University of Texas MD Anderson Cancer Center /ID# 125353, Houston

79031

Lviv Oncological Regional Therapeutical and Diagnostic Centre /ID# 124974, Lviv

80045

Univ of Colorado Cancer Center /ID# 124983, Aurora

80218

Saint Joseph Hospital /ID# 131768, Denver

81675

Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 125256, Munich

83092

Donetsk Regional Antitumor Ctr /ID# 124970, Donetsk

85234

Banner MD Anderson Cancer Ctr /ID# 125011, Gilbert

89081

Universitaetsklinikum Ulm /ID# 135230, Ulm

89124

Grande Ospedale Metropolitano Bianchi Melacrino Morelli /ID# 125263, Reggio Calabria

90603

Icri /Id# 128520, Whittier

91010

City of Hope /ID# 127117, Duarte

91031

Shaare Zedek Medical Center /ID# 130275, Jerusalem

91120

Gastroenterology Institute, Division of Medicine /ID# 124919, Jerusalem

92093

Moores Cancer Center at UC San Diego /ID# 124991, La Jolla

92210

Institut Curie - site CLCC René Huguenin /ID# 124904, Saint-Cloud

92663

Hematology and Oncology Assoc /ID# 130058, Newport Beach

92705

Cancer Research Collaboration /ID# 128860, Santa Ana

93720

California Cancer Associates for Research & Excellence (cCARE) /ID# 136078, Fresno

97133

Centro de Estudios Clínicos Especializados /ID# 128680, Mérida

97239

Oregon Health and Science University /ID# 134229, Portland

98104

Swedish Cancer Institute - Edmonds /ID# 131549, Seattle

Swedish Medical Center /ID# 125021, Seattle

98405

Northwest Medical Specialties - Tacoma /ID# 125344, Tacoma

110221

Administradora del Country_S.A-Clinica Del Country /ID# 125255, Bogota

110231

Hospital Univ San Ignacio /ID# 126655, Bogota

119074

National University Hospital /ID# 125315, Singapore

163045

Duplicate_archangel Clinical Oncology /ID# 126031, Arkhangelsk

197342

LLC BioEq Ltd. /ID# 134529, Saint Petersburg

200347

S.C. Centrul de Oncologie Sf. Nectarie S.R.L. /ID# 124948, Craiova

210603

Vitebsk Regional Clinical Oncology Dispensary /ID# 125219, Vitebsk

212018

Duplicate_Mogilev Reg Clin Oncology Dis /ID# 137728, Mogilev

213825

Bobruysk Interdistrict Onco. /ID# 137729, Babruysk

223040

State Institution Republican Scientific Practical Center of Oncology and Medical /ID# 125223, Minsk

230002

Instituto Medico de Alta Tecnologia Oncomédica S.A /ID# 129211, Montería

300239

Oncomed SRL /ID# 127598, Timișoara

305035

Regional Oncology Dispensary /ID# 125936, Kursk

308010

Belgorod Oncology Dispensary /ID# 129315, Belgorod

308433

Johns Hopkins Singapore IMC /ID# 125316, Singapore

400006

Spitalul Clinic Judetean de Urgenta Cluj -Napoca /ID# 124945, Cluj-Napoca

404130

Volgograd Regional Clinical Oncology Dispensary /ID# 124952, Volzhsky

410012

Duplicate_Saratov State Medical University n.s. Chernyshevskiy /ID# 139395, Saratov

620043

Sverdlovsk Regional Oncology Dispensary /ID# 130950, Yekaterinburg

634050

Siberian State Medical University /ID# 127161, Tomsk

656049

Altay Regional Oncological Dispesary /ID# 127160, Barnaul

2520612

Hospital Clinico Vina del Mar /ID# 130100, Viña del Mar

Hospital Clinico Vina del Mar /ID# 148502, Viña del Mar

3109601

Rambam Health Care Campus /ID# 124916, Haifa

4810469

ICOS - Inst Clinic Oncology /ID# 125236, Temuco

5265601

The Chaim Sheba Medical Center /ID# 124918, Ramat Gan

6423906

Tel Aviv Sourasky Medical Center /ID# 130276, Tel Aviv

7661041

Kaplan Medical Center /ID# 124914, Rehovot

8380455

Instituto Nacional del Cancer /ID# 129343, Santiago

8457101

Duplicate_Soroka University Medical Center /ID# 124917, Beersheba

06856

Norwalk Hospital /ID# 133509, Norwalk

33612-9416

Moffitt Cancer Center /ID# 124990, Tampa

01199

Baystate Medical Center /ID# 139461, Springfield

01655

UMass Chan Medical School /ID# 129067, Worcester

48073-6710

William Beaumont Hospital /ID# 125019, Royal Oak

39216-4643

Univ of Mississippi Med Ctr,US /ID# 131352, Jackson

64111-5905

St. Lukes Cancer Institute /ID# 125023, Kansas City

08901

Rutgers Cancer Institute of New Jersey /ID# 125017, New Brunswick

87102-4517

University of New Mexico /ID# 125349, Albuquerque

27710-3000

Duke Cancer Center /ID# 124999, Durham

75390-7208

University of Texas Southwestern Medical Center /ID# 124989, Dallas

05401-1473

University of Vermont Medical Center /ID# 125350, Burlington

98029-6201

Swedish Cancer Institute - Issaquah /ID# 131534, Issaquah

98107-3932

Swedish Cancer Insititute - Ballard /ID# 131548, Seattle

M4N 3M5

Duplicate_Sunnybrook Health Sciences Ctr /ID# 124882, Toronto

H2X 0A9

CHUM - Notre-Dame Hospital /ID# 124879, Montreal

H3T 1E2

Duplicate_Jewish General Hospital /ID# 124880, Montreal

G1S 4L8

Duplicate_CHUQ-Hospital St. Sacrement /ID# 124881, Québec

Unknown

Centro Medico Imbanaco de Cali /ID# 126656, Santiago de Cali

625 00

Fakultni Nemocnice Brno /ID# 128176, Brno

656 53

Masarykuv onkologicky ustav /ID# 124886, Brno

500 05

Duplicate_FN Hradec Kralove /ID# 127080, Hradec Králové

779 00

Fakultni nemocnice Olomouc /ID# 124885, Olomouc

128 08

Vseobecna fakultni nemocnice v Praze /ID# 124887, Prague

00180

Docrates Cancer Center /ID# 124896, Helsinki

00290

Duplicate_Helsinki Univ Central Hospital /ID# 124897, Helsinki

01307

Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 127180, Dresden

LV-1079

Riga East Clinical University Hospital /ID# 125265, Riga

08660

National Cancer Institute /ID# 125267, Vilnius

3015 GD

Erasmus Medisch Centrum /ID# 124935, Rotterdam

9713 GZ

Universitair Medisch Centrum Groningen /ID# 129069, Groningen

6229 HX

Maastricht Universitair Medisch Centrum /ID# 129068, Maastricht

85-796

Centrum Onkologii Lukaszczyka /ID# 124938, Bydgoszcz

51-124

Wojewodzki Szpital Specjalistyczny /ID# 127258, Wroclaw

35-021

MRUK-MED I Spolka z ograniczona odpowiedzialnoscia /ID# 124939, Rzeszów

82-300

Wojewodzki Szpital Zespolony /ID# 126998, Elblag

93-513

Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopern /ID# 126999, Lodz

4434-502

Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE /ID# 126510, Vila Nova de Gaia

8000-386

Centro Hospitalar Universitário do Algarve, EPE - Hospital Faro /ID# 125298, Faro

1649-035

Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 125299, Lisbon

4464-513

Unidade Local de Saúde de Matosinhos, EPE /ID# 126511, Matosinhos Municipality

4200-072

IPO Porto FG, EPE /ID# 125297, Porto

4200-319

Centro Hospitalar Universitario de Sao Joao, EPE /ID# 126508, Porto

00717

Ad-Vance Medical Research, LLC /ID# 126043, Ponce

00935

San Juan Municipal Hospital /ID# 124695, San Juan

022328

Duplicate_lnstitutul Oncologic Prof Dr Alexandru Trestioreanu /ID# 124943, Bucharest

0181

Mary Potter Oncology Centre /ID# 133269, Pretoria

03722

Yonsei University Health System Severance Hospital /ID# 125599, Seoul

02841

Korea University Anam Hospital /ID# 128968, Seoul

03080

Seoul National University Hospital /ID# 125600, Seoul

05505

Asan Medical Center /ID# 125601, Seoul

06351

Samsung Medical Center /ID# 125598, Seoul

08041

Hospital Santa Creu i Sant Pau /ID# 124963, Barcelona

214 28

Skane University hospital /ID# 124966, Malmo

581 85

Norrlands University hospital /ID# 124967, Umeå

Linkoping University Hospital /ID# 126795, Linköping

413 45

Sahlgrenska University Hospital /ID# 124965, Gothenburg

171 64

Duplicate_Karolinska Univ Sjukhuset /ID# 124964, Solna

06100

Hacettepe University Faculty of Medicine /ID# 125336, Ankara

06200

Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi /ID# 125337, Ankara

07059

Duplicate_Akdeniz University Medical Fac /ID# 125339, Antalya

BS2 8ED

University Hospitals Bristol /ID# 128343, Bristol

HU3 2JZ

Hull University Teaching Hospitals NHS Trust /ID# 133030, Hull

NG5 1PB

Nottingham University Hospitals NHS Trust /ID# 125340, Nottingham

B15 2TH

University Hospitals Birmingham NHS Foundation Trust /ID# 125342, Birmingham

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