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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

Primary Purpose

Metastatic Breast Cancer

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Veliparib Placebo
Veliparib
Carboplatin
Paclitaxel
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Breast Cancer focused on measuring PARP Inhibitor, Veliparib, BRCA1, BRCA2, HER2-negative, Locally recurrent, Breast Cancer, Metastatic Breast Cancer, ABT-888, Genetic breast cancer, Paclitaxel, BRCA Mutation, PARP, Carboplatin, BROCADE3

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Banner MD Anderson Cancer Ctr /ID# 125011
  • University of Arkansas for Medical Sciences /ID# 124992
  • City of Hope /ID# 127117
  • California Cancer Associates for Research & Excellence (cCARE) /ID# 136078
  • Moores Cancer Center at UC San Diego /ID# 124991
  • Hematology and Oncology Assoc /ID# 130058
  • Cancer Research Collaboration /ID# 128860
  • Icri /Id# 128520
  • Univ of Colorado Cancer Center /ID# 124983
  • Saint Joseph Hospital /ID# 131768
  • Norwalk Hospital /ID# 133509
  • Lynn Cancer Institute, Boca /ID# 125013
  • Holy Cross Hospital /ID# 125012
  • Sacred Heart Hospital /ID# 128279
  • Moffitt Cancer Center /ID# 124990
  • Florida Cancer Specialists - East /ID# 125007
  • Emory Midtown Infectious Disease Clinic /ID# 133192
  • The Cancer Ctr at DeKalb Med C /ID# 125024
  • University of Illinois - Chicago /ID# 127576
  • NorthShore University HealthSystem /ID# 124996
  • Midwestern Regional CTC /ID# 124986
  • McFarland Clinic, PC /ID# 129904
  • Johns Hopkins University /ID# 125015
  • Baystate Medical Center /ID# 139461
  • UMass Chan Medical School /ID# 129067
  • Henry Ford Health System /ID# 134497
  • Spectrum Health Medical Group /ID# 133568
  • Spectrum Health Medical Group /ID# 148471
  • William Beaumont Hospital /ID# 125019
  • Univ of Mississippi Med Ctr,US /ID# 131352
  • St. Lukes Cancer Institute /ID# 125023
  • Washington University-School of Medicine /ID# 127575
  • Nebraska Hematology Oncology /ID# 132711
  • Rutgers Cancer Institute of New Jersey /ID# 125017
  • University of New Mexico /ID# 125349
  • Beth Israel Medical Center /ID# 125001
  • Mount Sinai St. Luke's /ID# 125003
  • Mission Cancer Center /ID# 134248
  • Duke Cancer Center /ID# 124999
  • The Ohio State University /ID# 125022
  • University of Toledo /ID# 134849
  • Oregon Health and Science University /ID# 134229
  • Lehigh Valley Health Network /ID# 130059
  • Lehigh Valley Hosp/Muhlenberg /ID# 130277
  • Penn State University and Milton S. Hershey Medical Center /ID# 124997
  • Allegheny General Hospital /ID# 135094
  • University of Pittsburgh MC /ID# 125005
  • Texas Health Physicians Group /ID# 137740
  • University of Texas Southwestern Medical Center /ID# 124989
  • University of Texas MD Anderson Cancer Center /ID# 125353
  • University of Vermont Medical Center /ID# 125350
  • Swedish Cancer Institute - Issaquah /ID# 131534
  • Swedish Cancer Institute - Edmonds /ID# 131549
  • Swedish Medical Center /ID# 125021
  • Swedish Cancer Insititute - Ballard /ID# 131548
  • Northwest Medical Specialties - Tacoma /ID# 125344
  • COIBA Centro de Oncologia e Investigacion de Buenos Aires /ID# 124839
  • Clinica Pergamino /ID# 127158
  • Instituto de Oncoloia de Rosario /ID# 127157
  • Centro Oncologico Riojano Integral /ID# 127938
  • St George Hospital /ID# 129416
  • Duplicate_The Prince of Wales Hospital /ID# 124845
  • Southern Medical Day Care Centre /ID# 124844
  • Townsville University Hospital /ID# 126731
  • Duplicate_Flinders Centre for Innovation /ID# 127535
  • Royal Hobart Hospital /ID# 124849
  • The Royal Melbourne Hospital /ID# 124846
  • Hollywood Private Hospital /ID# 124843
  • Ordensklinikum Linz GmbH Elisabethinen /ID# 126185
  • Medizinische Universitaet Graz /ID# 126450
  • Medizinische Universitaet Wien /ID# 126184
  • Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 126449
  • Bobruysk Interdistrict Onco. /ID# 137729
  • State Institution Republican Scientific Practical Center of Oncology and Medical /ID# 125223
  • Duplicate_Mogilev Reg Clin Oncology Dis /ID# 137728
  • Vitebsk Regional Clinical Oncology Dispensary /ID# 125219
  • Universitair Ziekenhuis Antwerpen /ID# 124977
  • UCL Saint-Luc /ID# 124976
  • Grand Hôpital de Charleroi /ID# 124981
  • Universitair Ziekenhuis Leuven /ID# 124980
  • Duplicate_AZ St-Jan Brugge-Oostende AV /ID# 124975
  • ZNA Middelheim /ID# 124978
  • CHU UCL Namur - Sainte Elisabeth /ID# 124979
  • Duplicate_Sunnybrook Health Sciences Ctr /ID# 124882
  • Duplicate_Jewish General Hospital /ID# 124880
  • CHUM - Notre-Dame Hospital /ID# 124879
  • Duplicate_CHUQ-Hospital St. Sacrement /ID# 124881
  • Hospital Clinico Vina del Mar /ID# 130100
  • Hospital Clinico Vina del Mar /ID# 148502
  • Instituto Nacional del Cancer /ID# 129343
  • ICOS - Inst Clinic Oncology /ID# 125236
  • Hospital Pablo Tobon Uribe /ID# 126657
  • Instituto Medico de Alta Tecnologia Oncomédica S.A /ID# 129211
  • Administradora del Country_S.A-Clinica Del Country /ID# 125255
  • Hospital Univ San Ignacio /ID# 126655
  • Centro Medico Imbanaco de Cali /ID# 126656
  • Fakultni Nemocnice Brno /ID# 128176
  • Masarykuv onkologicky ustav /ID# 124886
  • Duplicate_FN Hradec Kralove /ID# 127080
  • Fakultni nemocnice Olomouc /ID# 124885
  • Vseobecna fakultni nemocnice v Praze /ID# 124887
  • Rigshospitalet /ID# 124891
  • Sygehus Lillebælt, Vejle /ID# 124892
  • East Tallinn Central Hospital /ID# 126475
  • Docrates Cancer Center /ID# 124896
  • Duplicate_Helsinki Univ Central Hospital /ID# 124897
  • Duplicate_Tampere University Hospital /ID# 124898
  • Vaasa Central Hospital /ID# 132548
  • Institut Paoli-Calmettes /ID# 124903
  • Institut Curie /ID# 124902
  • Institut de Cancérologie de l'Ouest René Gauducheau /ID# 137726
  • Institut Curie - site CLCC René Huguenin /ID# 124904
  • Universitaetsklinik Heidelberg /ID# 126664
  • Universitaetsklinimum Tuebingen /ID# 129968
  • Universitaetsklinikum Ulm /ID# 135230
  • Universitaetsklinikum Koeln /ID# 126905
  • Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 127180
  • Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 125256
  • Sana Klinikum Offenbach /ID# 126733
  • Semmelweis Egyetem /ID# 132485
  • Pecsi Tudomanyegyetem Klinikai Kozpont /ID# 125259
  • Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz /ID# 124911
  • Duplicate_Zala Megyei Korhaz /ID# 131341
  • The Chaim Sheba Medical Center /ID# 124918
  • Tel Aviv Sourasky Medical Center /ID# 130276
  • Duplicate_Soroka University Medical Center /ID# 124917
  • Assaf Harofeh Medical Center /ID# 124915
  • Rambam Health Care Campus /ID# 124916
  • Shaare Zedek Medical Center /ID# 130275
  • Gastroenterology Institute, Division of Medicine /ID# 124919
  • Kaplan Medical Center /ID# 124914
  • Ospedale San Raffaele IRCCS /ID# 125261
  • IEO -Istituto Europeo di Oncologia /ID# 125260
  • IRCCS Ospedale Sacro Cuore Don Calabria /ID# 125262
  • Centro di Riferimento Oncologico /ID# 126738
  • Grande Ospedale Metropolitano Bianchi Melacrino Morelli /ID# 125263
  • National Cancer Center /ID# 125602
  • Yonsei University Health System Severance Hospital /ID# 125599
  • Korea University Anam Hospital /ID# 128968
  • Seoul National University Hospital /ID# 125600
  • Asan Medical Center /ID# 125601
  • Samsung Medical Center /ID# 125598
  • Pauls Stradins Clinical University Hospital /ID# 125264
  • Riga East Clinical University Hospital /ID# 125265
  • Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 125266
  • National Cancer Institute /ID# 125267
  • Centro de Estudios Clínicos Especializados /ID# 128680
  • Centro Oncologico de Chihuahua /ID# 128679
  • Instituto Nacional de Cancerología INCAN /ID# 128676
  • Erasmus Medisch Centrum /ID# 124935
  • Universitair Medisch Centrum Groningen /ID# 129069
  • Maastricht Universitair Medisch Centrum /ID# 129068
  • Haukeland University Hospital /ID# 150177
  • Wojewodzki Szpital Specjalistyczny /ID# 127258
  • Centrum Onkologii Lukaszczyka /ID# 124938
  • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopern /ID# 126999
  • MRUK-MED I Spolka z ograniczona odpowiedzialnoscia /ID# 124939
  • Wojewodzki Szpital Zespolony /ID# 126998
  • Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE /ID# 126510
  • Centro Hospitalar Universitário do Algarve, EPE - Hospital Faro /ID# 125298
  • Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 125299
  • Unidade Local de Saúde de Matosinhos, EPE /ID# 126511
  • IPO Porto FG, EPE /ID# 125297
  • Centro Hospitalar Universitario de Sao Joao, EPE /ID# 126508
  • Ad-Vance Medical Research, LLC /ID# 126043
  • San Juan Municipal Hospital /ID# 124695
  • S.C. Centrul de Oncologie Sf. Nectarie S.R.L. /ID# 124948
  • Duplicate_lnstitutul Oncologic Prof Dr Alexandru Trestioreanu /ID# 124943
  • Spitalul Clinic Judetean de Urgenta Cluj -Napoca /ID# 124945
  • Oncomed SRL /ID# 127598
  • Sverdlovsk Regional Oncology Dispensary /ID# 130950
  • Regional Oncology Dispensary /ID# 125936
  • Duplicate_archangel Clinical Oncology /ID# 126031
  • Altay Regional Oncological Dispesary /ID# 127160
  • Belgorod Oncology Dispensary /ID# 129315
  • Duplicate_Saratov State Medical University n.s. Chernyshevskiy /ID# 139395
  • LLC BioEq Ltd. /ID# 134529
  • Siberian State Medical University /ID# 127161
  • Volgograd Regional Clinical Oncology Dispensary /ID# 124952
  • National University Hospital /ID# 125315
  • Johns Hopkins Singapore IMC /ID# 125316
  • GVI Oncology /ID# 125321
  • University of Free State, Universitas Annex (National Hospital Grounds) /ID# 128499
  • Wits Clinical Research Site /ID# 125317
  • Medical Oncology Ctr Rosebank /ID# 125322
  • Sandton Oncology Medical Group PTY Ltd /ID# 125323
  • Mary Potter Oncology Centre /ID# 133269
  • The Oncology Centre /ID# 126104
  • Netcare Oncology Intervent Ctr /ID# 125320
  • Cancercare Outeniqua Oncology Centre /ID# 125319
  • Hospital Santa Creu i Sant Pau /ID# 124963
  • Hospital General Universitario Gregorio Maranon /ID# 124962
  • Hospital Universitario HM Sanchinarro /ID# 124960
  • Hospital Universitario Virgen de la Victoria /ID# 124961
  • Hospital Clinico Universitario de Valencia /ID# 124959
  • Skane University hospital /ID# 124966
  • Norrlands University hospital /ID# 124967
  • Sahlgrenska University Hospital /ID# 124965
  • Linkoping University Hospital /ID# 126795
  • Duplicate_Karolinska Univ Sjukhuset /ID# 124964
  • Uppsala University Hospital /ID# 126512
  • Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 125575
  • National Taiwan University Hospital /ID# 125324
  • Hacettepe University Faculty of Medicine /ID# 125336
  • Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi /ID# 125337
  • Duplicate_Akdeniz University Medical Fac /ID# 125339
  • Bezmi Alem Univ Med Fac Hosp /ID# 127901
  • Istanbul University Istanbul Medical Faculty /ID# 145144
  • Municipal Non-Profit Enterprise City Clinical Hospital No.4 of Dnipro City Counc /ID# 124968
  • Donetsk Regional Antitumor Ctr /ID# 124970
  • Communal non-profit enterprise Regional Center of Oncology /ID# 124972
  • Lviv Oncological Regional Therapeutical and Diagnostic Centre /ID# 124974
  • Poltava Regional Clinical Oncology Centre of Poltava Regional Council /ID# 124969
  • Zaporizhzhia Med. Academy MOH /ID# 129800
  • ME Kryviy Rih Oncology Dispensary /ID# 129806
  • University Hospitals Bristol /ID# 128343
  • Hull University Teaching Hospitals NHS Trust /ID# 133030
  • Nottingham University Hospitals NHS Trust /ID# 125340
  • University Hospitals Birmingham NHS Foundation Trust /ID# 125342

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Veliparib Placebo with Carboplatin and Paclitaxel

Veliparib with Carboplatin and Paclitaxel

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Clinical Benefit Rate (CBR)
The clinical benefit rate (CBR) for each treatment group was to be obtained from a time-to-event analysis of radiographic disease progression per the investigator. CBR is defined as the progression-free rate at 24 weeks (168 days), estimated for each treatment arm 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. The final analysis of CBR will occur when the pre-specified number of Overall Survival events have occurred in the ITT population, per the fixed sequence testing procedure.
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.
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.

Full Information

First Posted
May 19, 2014
Last Updated
February 14, 2023
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT02163694
Brief Title
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
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 17, 2014 (Actual)
Primary Completion Date
April 5, 2019 (Actual)
Study Completion Date
January 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Breast Cancer
Keywords
PARP Inhibitor, Veliparib, BRCA1, BRCA2, HER2-negative, Locally recurrent, Breast Cancer, Metastatic Breast Cancer, ABT-888, Genetic breast cancer, Paclitaxel, BRCA Mutation, PARP, Carboplatin, BROCADE3

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
509 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Veliparib Placebo with Carboplatin and Paclitaxel
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Veliparib with Carboplatin and Paclitaxel
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Veliparib Placebo
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Veliparib
Other Intervention Name(s)
ABT-888
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
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.
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS)
Description
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.
Time Frame
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 Measure Information:
Title
Overall Survival (OS)
Description
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.
Time Frame
Approximately 8 years from randomization
Title
Clinical Benefit Rate (CBR)
Description
The clinical benefit rate (CBR) for each treatment group was to be obtained from a time-to-event analysis of radiographic disease progression per the investigator. CBR is defined as the progression-free rate at 24 weeks (168 days), estimated for each treatment arm 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. The final analysis of CBR will occur when the pre-specified number of Overall Survival events have occurred in the ITT population, per the fixed sequence testing procedure.
Time Frame
Through the end of Week 24
Title
Objective Response Rate (ORR)
Description
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.
Time Frame
Approximately 8 years from randomization
Title
Progression-Free Survival on Subsequent Therapy (PFS2)
Description
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.
Time Frame
Approximately 8 years from randomization

10. Eligibility

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

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://vivli.org/ourmember/abbvie/
Citations:
PubMed Identifier
35403245
Citation
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.
Results Reference
derived
PubMed Identifier
34917174
Citation
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.
Results Reference
derived
PubMed Identifier
34243076
Citation
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.
Results Reference
derived
PubMed Identifier
34131001
Citation
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.
Results Reference
derived
PubMed Identifier
32861273
Citation
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.
Results Reference
derived

Learn more about this trial

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

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