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
2 other identifiers
interventional
513
34 countries
199
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2014
Longer than P75 for phase_3
199 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 8, 2014
CompletedFirst Submitted
Initial submission to the registry
May 19, 2014
CompletedFirst Posted
Study publicly available on registry
June 16, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 5, 2019
CompletedResults Posted
Study results publicly available
April 4, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 25, 2024
CompletedFebruary 19, 2025
February 1, 2025
5 years
May 19, 2014
March 11, 2022
February 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Overall Survival (OS)
Up to 84.5 and 81.8 months for Placebo and Veliparib, respectively.
Clinical Benefit Rate (CBR)
Through the end of Week 24
Objective Response Rate (ORR)
Approximately 8 years from randomization
Progression-Free Survival on Subsequent Therapy (PFS2)
Approximately 8 years from randomization
Study Arms (2)
Veliparib Placebo with Carboplatin and Paclitaxel
ACTIVE COMPARATORPlacebo 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.
Veliparib with Carboplatin and Paclitaxel
EXPERIMENTALVeliparib 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.
Interventions
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.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
- Suspected deleterious or deleterious Breast Cancer Gene 1 (BRCA1) and/or Breast Cancer Gene 2 (BRCA2) germline mutation.
- Breast cancer must be Human Epidermal Growth Factor Receptor 2 (HER2)-negative.
- 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.
- Eastern Cooperative Oncology Group (ECOG) Performance status of 0 to 2.
- Adequate hematologic, renal, and hepatic function (within 28 days of randomization).
You may not qualify if:
- 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.
- 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).
- Prior therapy with Poly(ADP-ribose)-Polymerase (PARP) inhibitors.
- 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
- 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.
- Active CNS metastases or leptomeningeal disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (219)
Banner MD Anderson Cancer Ctr /ID# 125011
Gilbert, Arizona, 85234, United States
University of Arkansas for Medical Sciences /ID# 124992
Little Rock, Arkansas, 72205, United States
City of Hope /ID# 127117
Duarte, California, 91010, United States
California Cancer Associates for Research & Excellence (cCARE) /ID# 136078
Fresno, California, 93720, United States
Moores Cancer Center at UC San Diego /ID# 124991
La Jolla, California, 92093, United States
Hematology and Oncology Assoc /ID# 130058
Newport Beach, California, 92663, United States
Cancer Research Collaboration /ID# 128860
Santa Ana, California, 92705, United States
Icri /Id# 128520
Whittier, California, 90603, United States
Univ of Colorado Cancer Center /ID# 124983
Aurora, Colorado, 80045, United States
Saint Joseph Hospital /ID# 131768
Denver, Colorado, 80218, United States
Norwalk Hospital /ID# 133509
Norwalk, Connecticut, 06856, United States
Lynn Cancer Institute, Boca /ID# 125013
Boca Raton, Florida, 33486, United States
Holy Cross Hospital /ID# 125012
Fort Lauderdale, Florida, 33308, United States
Sacred Heart Hospital /ID# 128279
Pensacola, Florida, 32504, United States
Moffitt Cancer Center /ID# 124990
Tampa, Florida, 33612-9416, United States
Florida Cancer Specialists - East /ID# 125007
West Palm Beach, Florida, 33401, United States
Emory Midtown Infectious Disease Clinic /ID# 133192
Atlanta, Georgia, 30322, United States
The Cancer Ctr at DeKalb Med C /ID# 125024
Decatur, Georgia, 30033, United States
University of Illinois - Chicago /ID# 127576
Chicago, Illinois, 60607, United States
NorthShore University HealthSystem /ID# 124996
Evanston, Illinois, 60201, United States
Midwestern Regional CTC /ID# 124986
Zion, Illinois, 60099, United States
McFarland Clinic, PC /ID# 129904
Ames, Iowa, 50010, United States
Johns Hopkins University /ID# 125015
Baltimore, Maryland, 21287, United States
Baystate Medical Center /ID# 139461
Springfield, Massachusetts, 01199, United States
UMass Chan Medical School /ID# 129067
Worcester, Massachusetts, 01655, United States
Henry Ford Health System /ID# 134497
Detroit, Michigan, 48202, United States
Spectrum Health Medical Group /ID# 133568
Grand Rapids, Michigan, 49503, United States
Spectrum Health Medical Group /ID# 148471
Grand Rapids, Michigan, 49503, United States
William Beaumont Hospital /ID# 125019
Royal Oak, Michigan, 48073-6710, United States
Univ of Mississippi Med Ctr,US /ID# 131352
Jackson, Mississippi, 39216-4643, United States
St. Lukes Cancer Institute /ID# 125023
Kansas City, Missouri, 64111-5905, United States
Washington University-School of Medicine /ID# 127575
St Louis, Missouri, 63110, United States
Nebraska Hematology Oncology /ID# 132711
Lincoln, Nebraska, 68506, United States
Rutgers Cancer Institute of New Jersey /ID# 125017
New Brunswick, New Jersey, 08901, United States
University of New Mexico /ID# 125349
Albuquerque, New Mexico, 87102-4517, United States
Beth Israel Medical Center /ID# 125001
New York, New York, 10003, United States
Mount Sinai St. Luke's /ID# 125003
New York, New York, 10025, United States
Mission Cancer Center /ID# 134248
Asheville, North Carolina, 28801, United States
Duke Cancer Center /ID# 124999
Durham, North Carolina, 27710-3000, United States
The Ohio State University /ID# 125022
Columbus, Ohio, 43210, United States
University of Toledo /ID# 134849
Toledo, Ohio, 43614, United States
Oregon Health and Science University /ID# 134229
Portland, Oregon, 97239, United States
Lehigh Valley Health Network /ID# 130059
Allentown, Pennsylvania, 18103, United States
Lehigh Valley Hosp/Muhlenberg /ID# 130277
Bethlehem, Pennsylvania, 18017, United States
Penn State University and Milton S. Hershey Medical Center /ID# 124997
Hershey, Pennsylvania, 17033, United States
Allegheny General Hospital /ID# 135094
Pittsburgh, Pennsylvania, 15212, United States
University of Pittsburgh MC /ID# 125005
Pittsburgh, Pennsylvania, 15260, United States
Texas Health Physicians Group /ID# 137740
Arlington, Texas, 76012, United States
University of Texas Southwestern Medical Center /ID# 124989
Dallas, Texas, 75390-7208, United States
University of Texas MD Anderson Cancer Center /ID# 125353
Houston, Texas, 77030, United States
University of Vermont Medical Center /ID# 125350
Burlington, Vermont, 05401-1473, United States
Swedish Cancer Institute - Issaquah /ID# 131534
Issaquah, Washington, 98029-6201, United States
Swedish Cancer Institute - Edmonds /ID# 131549
Seattle, Washington, 98104, United States
Swedish Medical Center /ID# 125021
Seattle, Washington, 98104, United States
Swedish Cancer Insititute - Ballard /ID# 131548
Seattle, Washington, 98107-3932, United States
Northwest Medical Specialties - Tacoma /ID# 125344
Tacoma, Washington, 98405, United States
COIBA Centro de Oncologia e Investigacion de Buenos Aires /ID# 124839
Berazategui, Buenos Aires, 1884, Argentina
Clinica Pergamino /ID# 127158
Pergamino, Buenos Aires, 2700, Argentina
Instituto de Oncoloia de Rosario /ID# 127157
Rosario, Santa Fe Province, 2000, Argentina
Centro Oncologico Riojano Integral /ID# 127938
La Rioja, 5300, Argentina
St George Hospital /ID# 129416
Kogarah, New South Wales, 2217, Australia
Duplicate_The Prince of Wales Hospital /ID# 124845
Randwick, New South Wales, 2031, Australia
Southern Medical Day Care Centre /ID# 124844
Wollongong, New South Wales, 2500, Australia
Townsville University Hospital /ID# 126731
Douglas, Queensland, 4814, Australia
Duplicate_Flinders Centre for Innovation /ID# 127535
Bedford Park, South Australia, 5042, Australia
Royal Hobart Hospital /ID# 124849
Hobart, Tasmania, 7000, Australia
The Royal Melbourne Hospital /ID# 124846
Parkville, Victoria, 3050, Australia
Hollywood Private Hospital /ID# 124843
Nedlands, Western Australia, 6009, Australia
Medizinische Universitaet Graz /ID# 126450
Graz, Styria, 8036, Austria
Ordensklinikum Linz GmbH Elisabethinen /ID# 126185
Linz, Upper Austria, 4010, Austria
Medizinische Universitaet Wien /ID# 126184
Vienna, Vienna, 1090, Austria
Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 126449
Salzburg, 5020, Austria
Bobruysk Interdistrict Onco. /ID# 137729
Babruysk, 213825, Belarus
State Institution Republican Scientific Practical Center of Oncology and Medical /ID# 125223
Minsk, 223040, Belarus
Duplicate_Mogilev Reg Clin Oncology Dis /ID# 137728
Mogilev, 212018, Belarus
Vitebsk Regional Clinical Oncology Dispensary /ID# 125219
Vitebsk, 210603, Belarus
Universitair Ziekenhuis Antwerpen /ID# 124977
Edegem, Antwerpen, 2650, Belgium
UCL Saint-Luc /ID# 124976
Woluwe-Saint-Lambert, Brussels Capital, 1200, Belgium
Grand Hôpital de Charleroi /ID# 124981
Charleroi, Hainaut, 6000, Belgium
Universitair Ziekenhuis Leuven /ID# 124980
Leuven, Vlaams-Brabant, 3000, Belgium
Duplicate_AZ St-Jan Brugge-Oostende AV /ID# 124975
Bruges, West-Vlaanderen, 8000, Belgium
ZNA Middelheim /ID# 124978
Antwerp, 2020, Belgium
CHU UCL Namur - Sainte Elisabeth /ID# 124979
Namur, 5000, Belgium
Duplicate_Sunnybrook Health Sciences Ctr /ID# 124882
Toronto, Ontario, M4N 3M5, Canada
CHUM - Notre-Dame Hospital /ID# 124879
Montreal, Quebec, H2X 0A9, Canada
Duplicate_Jewish General Hospital /ID# 124880
Montreal, Quebec, H3T 1E2, Canada
Duplicate_CHUQ-Hospital St. Sacrement /ID# 124881
Québec, Quebec, G1S 4L8, Canada
Hospital Clinico Vina del Mar /ID# 130100
Viña del Mar, Región de Valparaíso, 2520612, Chile
Hospital Clinico Vina del Mar /ID# 148502
Viña del Mar, Región de Valparaíso, 2520612, Chile
Instituto Nacional del Cancer /ID# 129343
Santiago, 8380455, Chile
ICOS - Inst Clinic Oncology /ID# 125236
Temuco, 4810469, Chile
Hospital Pablo Tobon Uribe /ID# 126657
Medellín, Antioquia, 50034, Colombia
Administradora del Country_S.A-Clinica Del Country /ID# 125255
Bogota, Cundinamarca, 110221, Colombia
Hospital Univ San Ignacio /ID# 126655
Bogota, Cundinamarca, 110231, Colombia
Instituto Medico de Alta Tecnologia Oncomédica S.A /ID# 129211
Montería, Departamento de Córdoba, 230002, Colombia
Centro Medico Imbanaco de Cali /ID# 126656
Cali, Colombia
Fakultni Nemocnice Brno /ID# 128176
Brno, 625 00, Czechia
Masarykuv onkologicky ustav /ID# 124886
Brno, 656 53, Czechia
Duplicate_FN Hradec Kralove /ID# 127080
Hradec Králové, 500 05, Czechia
Fakultni nemocnice Olomouc /ID# 124885
Olomouc, 779 00, Czechia
Vseobecna fakultni nemocnice v Praze /ID# 124887
Prague, 128 08, Czechia
Rigshospitalet /ID# 124891
Copenhagen Ø, Capital Region, 2100, Denmark
Sygehus Lillebælt, Vejle /ID# 124892
Vejle, Region Syddanmark, 7100, Denmark
East Tallinn Central Hospital /ID# 126475
Kesklinn, Harju, 10138, Estonia
Docrates Cancer Center /ID# 124896
Helsinki, 00180, Finland
Duplicate_Helsinki Univ Central Hospital /ID# 124897
Helsinki, 00290, Finland
Duplicate_Tampere University Hospital /ID# 124898
Tampere, 33521, Finland
Vaasa Central Hospital /ID# 132548
Vaasa, 65130, Finland
Institut Paoli-Calmettes /ID# 124903
Marseille, Bouches-du-Rhone, 13009, France
Institut de Cancérologie de l'Ouest René Gauducheau /ID# 137726
Saint-Herblain, Loire-Atlantique, 44805, France
Institut Curie - site CLCC René Huguenin /ID# 124904
Saint-Cloud, 92210, France
Institut Curie /ID# 124902
Paris, Île-de-France Region, 75248, France
Universitaetsklinik Heidelberg /ID# 126664
Heidelberg, Baden-Wurttemberg, 69120, Germany
Universitaetsklinimum Tuebingen /ID# 129968
Tübingen, Baden-Wurttemberg, 72076, Germany
Universitaetsklinikum Ulm /ID# 135230
Ulm, Baden-Wurttemberg, 89081, Germany
Universitaetsklinikum Koeln /ID# 126905
Cologne, North Rhine-Westphalia, 50937, Germany
Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 127180
Dresden, 01307, Germany
Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 125256
Munich, 81675, Germany
Sana Klinikum Offenbach /ID# 126733
Offenbach, 63069, Germany
Semmelweis Egyetem /ID# 132485
Budapest, 1085, Hungary
Pecsi Tudomanyegyetem Klinikai Kozpont /ID# 125259
Pécs, 7624, Hungary
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz /ID# 124911
Szolnok, 5000, Hungary
Duplicate_Zala Megyei Korhaz /ID# 131341
Zalaegerszeg, 8900, Hungary
The Chaim Sheba Medical Center /ID# 124918
Ramat Gan, Tel Aviv, 5265601, Israel
Tel Aviv Sourasky Medical Center /ID# 130276
Tel Aviv, Tel Aviv, 6423906, Israel
Duplicate_Soroka University Medical Center /ID# 124917
Beersheba, 8457101, Israel
Assaf Harofeh Medical Center /ID# 124915
Be’er Ya‘aqov, 70300, Israel
Rambam Health Care Campus /ID# 124916
Haifa, 3109601, Israel
Shaare Zedek Medical Center /ID# 130275
Jerusalem, 91031, Israel
Gastroenterology Institute, Division of Medicine /ID# 124919
Jerusalem, 91120, Israel
Kaplan Medical Center /ID# 124914
Rehovot, 7661041, Israel
Ospedale San Raffaele IRCCS /ID# 125261
Milan, Lombardy, 20132, Italy
IEO -Istituto Europeo di Oncologia /ID# 125260
Milan, Milano, 20141, Italy
IRCCS Ospedale Sacro Cuore Don Calabria /ID# 125262
Negrar, Verona, 37024, Italy
Centro di Riferimento Oncologico /ID# 126738
Aviano, 33081, Italy
Grande Ospedale Metropolitano Bianchi Melacrino Morelli /ID# 125263
Reggio Calabria, 89124, Italy
Pauls Stradins Clinical University Hospital /ID# 125264
Riga, 1002, Latvia
Riga East Clinical University Hospital /ID# 125265
Riga, LV-1079, Latvia
Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 125266
Kaunas, 50161, Lithuania
National Cancer Institute /ID# 125267
Vilnius, 08660, Lithuania
Centro de Estudios Clínicos Especializados /ID# 128680
Mérida, Yucatán, 97133, Mexico
Centro Oncologico de Chihuahua /ID# 128679
Chihuahua City, 31217, Mexico
Instituto Nacional de Cancerología INCAN /ID# 128676
Mexico City, 14080, Mexico
Erasmus Medisch Centrum /ID# 124935
Rotterdam, South Holland, 3015 GD, Netherlands
Universitair Medisch Centrum Groningen /ID# 129069
Groningen, 9713 GZ, Netherlands
Maastricht Universitair Medisch Centrum /ID# 129068
Maastricht, 6229 HX, Netherlands
Haukeland University Hospital /ID# 150177
Bergen, Hordaland, 5021, Norway
Centrum Onkologii Lukaszczyka /ID# 124938
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796, Poland
Wojewodzki Szpital Specjalistyczny /ID# 127258
Wroclaw, Lower Silesian Voivodeship, 51-124, Poland
MRUK-MED I Spolka z ograniczona odpowiedzialnoscia /ID# 124939
Rzeszów, Podkarpackie Voivodeship, 35-021, Poland
Wojewodzki Szpital Zespolony /ID# 126998
Elblag, Warmian-Masurian Voivodeship, 82-300, Poland
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopern /ID# 126999
Lodz, Łódź Voivodeship, 93-513, Poland
Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE /ID# 126510
Vila Nova de Gaia, Porto District, 4434-502, Portugal
Centro Hospitalar Universitário do Algarve, EPE - Hospital Faro /ID# 125298
Faro, 8000-386, Portugal
Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 125299
Lisbon, 1649-035, Portugal
Unidade Local de Saúde de Matosinhos, EPE /ID# 126511
Matosinhos Municipality, 4464-513, Portugal
IPO Porto FG, EPE /ID# 125297
Porto, 4200-072, Portugal
Centro Hospitalar Universitario de Sao Joao, EPE /ID# 126508
Porto, 4200-319, Portugal
Ad-Vance Medical Research, LLC /ID# 126043
Ponce, 00717, Puerto Rico
San Juan Municipal Hospital /ID# 124695
San Juan, 00935, Puerto Rico
S.C. Centrul de Oncologie Sf. Nectarie S.R.L. /ID# 124948
Craiova, Dolj, 200347, Romania
Duplicate_lnstitutul Oncologic Prof Dr Alexandru Trestioreanu /ID# 124943
Bucharest, 022328, Romania
Spitalul Clinic Judetean de Urgenta Cluj -Napoca /ID# 124945
Cluj-Napoca, 400006, Romania
Oncomed SRL /ID# 127598
Timișoara, 300239, Romania
Sverdlovsk Regional Oncology Dispensary /ID# 130950
Yekaterinburg, Sverdlovsk Oblast, 620043, Russia
Regional Oncology Dispensary /ID# 125936
Kursk, Tatarstan, Respublika, 305035, Russia
Duplicate_archangel Clinical Oncology /ID# 126031
Arkhangelsk, 163045, Russia
Altay Regional Oncological Dispesary /ID# 127160
Barnaul, 656049, Russia
Belgorod Oncology Dispensary /ID# 129315
Belgorod, 308010, Russia
LLC BioEq Ltd. /ID# 134529
Saint Petersburg, 197342, Russia
Duplicate_Saratov State Medical University n.s. Chernyshevskiy /ID# 139395
Saratov, 410012, Russia
Siberian State Medical University /ID# 127161
Tomsk, 634050, Russia
Volgograd Regional Clinical Oncology Dispensary /ID# 124952
Volzhsky, 404130, Russia
National University Hospital /ID# 125315
Singapore, 119074, Singapore
Johns Hopkins Singapore IMC /ID# 125316
Singapore, 308433, Singapore
GVI Oncology /ID# 125321
Port Elizabeth, Eastern Cape, 6006, South Africa
University of Free State, Universitas Annex (National Hospital Grounds) /ID# 128499
Bloemfontein, Free State, 9301, South Africa
Wits Clinical Research Site /ID# 125317
Johannesburg, Gauteng, 2193, South Africa
Medical Oncology Ctr Rosebank /ID# 125322
Johannesburg, Gauteng, 2196, South Africa
Sandton Oncology Medical Group PTY Ltd /ID# 125323
Johannesburg, Gauteng, 2196, South Africa
Mary Potter Oncology Centre /ID# 133269
Pretoria, Gauteng, 0181, South Africa
The Oncology Centre /ID# 126104
Durban, KwaZulu-Natal, 4091, South Africa
Netcare Oncology Intervent Ctr /ID# 125320
Cape Town, Western Cape, 7460, South Africa
Cancercare Outeniqua Oncology Centre /ID# 125319
George, Western Cape, 6530, South Africa
National Cancer Center /ID# 125602
Goyang, Gyeonggido, 10408, South Korea
Yonsei University Health System Severance Hospital /ID# 125599
Seoul, Seoul Teugbyeolsi, 03722, South Korea
Korea University Anam Hospital /ID# 128968
Seoul, 02841, South Korea
Seoul National University Hospital /ID# 125600
Seoul, 03080, South Korea
Asan Medical Center /ID# 125601
Seoul, 05505, South Korea
Samsung Medical Center /ID# 125598
Seoul, 06351, South Korea
Hospital Santa Creu i Sant Pau /ID# 124963
Barcelona, 08041, Spain
Hospital General Universitario Gregorio Maranon /ID# 124962
Madrid, 28007, Spain
Hospital Universitario HM Sanchinarro /ID# 124960
Madrid, 28050, Spain
Hospital Universitario Virgen de la Victoria /ID# 124961
Málaga, 29010, Spain
Hospital Clinico Universitario de Valencia /ID# 124959
Valencia, 46010, Spain
Skane University hospital /ID# 124966
Malmo, Skåne County, 214 28, Sweden
Norrlands University hospital /ID# 124967
Umeå, Västerbotten County, 581 85, Sweden
Sahlgrenska University Hospital /ID# 124965
Gothenburg, Västra Götaland County, 413 45, Sweden
Linkoping University Hospital /ID# 126795
Linköping, 581 85, Sweden
Duplicate_Karolinska Univ Sjukhuset /ID# 124964
Solna, 171 64, Sweden
Uppsala University Hospital /ID# 126512
Uppsala, 75185, Sweden
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 125575
Kaohsiung City, 807, Taiwan
National Taiwan University Hospital /ID# 125324
Taipei, 100, Taiwan
Hacettepe University Faculty of Medicine /ID# 125336
Ankara, 06100, Turkey (Türkiye)
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi /ID# 125337
Ankara, 06200, Turkey (Türkiye)
Duplicate_Akdeniz University Medical Fac /ID# 125339
Antalya, 07059, Turkey (Türkiye)
Bezmi Alem Univ Med Fac Hosp /ID# 127901
Istanbul, 34093, Turkey (Türkiye)
Istanbul University Istanbul Medical Faculty /ID# 145144
Istanbul, 34093, Turkey (Türkiye)
Municipal Non-Profit Enterprise City Clinical Hospital No.4 of Dnipro City Counc /ID# 124968
Dnipro, 49102, Ukraine
Donetsk Regional Antitumor Ctr /ID# 124970
Donetsk, 83092, Ukraine
Communal non-profit enterprise Regional Center of Oncology /ID# 124972
Kharkiv, 61070, Ukraine
ME Kryviy Rih Oncology Dispensary /ID# 129806
Kryvyi Rih, 50048, Ukraine
Lviv Oncological Regional Therapeutical and Diagnostic Centre /ID# 124974
Lviv, 79031, Ukraine
Poltava Regional Clinical Oncology Centre of Poltava Regional Council /ID# 124969
Poltava, 36011, Ukraine
Zaporizhzhia Med. Academy MOH /ID# 129800
Zaporizhia, 69040, Ukraine
University Hospitals Bristol /ID# 128343
Bristol, Bristol, City of, BS2 8ED, United Kingdom
Hull University Teaching Hospitals NHS Trust /ID# 133030
Hull, East Riding Of Yorkshire, HU3 2JZ, United Kingdom
Nottingham University Hospitals NHS Trust /ID# 125340
Nottingham, Nottinghamshire, NG5 1PB, United Kingdom
University Hospitals Birmingham NHS Foundation Trust /ID# 125342
Birmingham, B15 2TH, United Kingdom
Related Publications (5)
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.
PMID: 35403245DERIVEDAyoub 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.
PMID: 34917174DERIVEDArun 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.
PMID: 34243076DERIVEDPuhalla 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.
PMID: 34131001DERIVEDDieras 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.
PMID: 32861273DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Medical Services
- Organization
- AbbVie
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 19, 2014
First Posted
June 16, 2014
Study Start
April 8, 2014
Primary Completion
April 5, 2019
Study Completion
January 25, 2024
Last Updated
February 19, 2025
Results First Posted
April 4, 2022
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- For details on when studies are available for sharing, please refer to the link below.
- 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.
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.