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CompletedNCT02163694Updated Feb 19, 2025Results posted

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

A Phase 3 interventional study of Veliparib Placebo and Veliparib in Metastatic Breast Cancer, sponsored by AbbVie. Completed at 219 sites in 37 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-19.

Sponsored by AbbVie · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
513
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Metastatic Breast Cancer

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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
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 513 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

AbbVie is the lead sponsor of 953 studies on the registry; 136 are open to participants now.

Of its 350 completed or terminated interventional studies of FDA-regulated products, 210 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
513 participants (actual)

Study arms

  • Active comparator
    Veliparib Placebo with Carboplatin and Paclitaxel

    Placebo capsules for veliparib (120 mg) administered by mouth twice daily (BID) on Days -2 through 5 of a 21-day cycle. Carboplatin administered intravenously over approximately 15 to 30 minutes at AUC 6 mg/ml/min immediately following paclitaxel infusion on Day 1 of every cycle. Paclitaxel administered intravenously over approximately 1 hour at a dose of 80 mg/m² on Days 1, 8, and 15 of every cycle.

    Drug: Veliparib Placebo · Drug: Carboplatin · Drug: Paclitaxel

  • Experimental
    Veliparib with Carboplatin and Paclitaxel

    Veliparib capsules (120 mg) administered by mouth twice daily (BID) on Days -2 through 5 of a 21-day cycle. Carboplatin administered intravenously over approximately 15 to 30 minutes at AUC 6 mg/ml/min immediately following paclitaxel infusion on Day 1 of every cycle. Paclitaxel administered intravenously over approximately 1 hour at a dose of 80 mg/m² on Days 1, 8, and 15 of every cycle.

    Drug: Veliparib · Drug: Carboplatin · Drug: Paclitaxel

Interventions

  • DrugVeliparib Placebo

    Supplied as 40 mg, 50 mg, or 100 mg capsules for oral administration twice daily (BID) on Days -2 through 5 of a 21-day cycle.

  • DrugVeliparib

    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.

    Also known as: ABT-888

  • DrugCarboplatin

    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.

  • DrugPaclitaxel

    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.

06

What researchers measure

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.

    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 outcomes

  1. 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.

    Time frame: Up to 84.5 and 81.8 months for Placebo and Veliparib, respectively.

  2. Clinical Benefit Rate (CBR)

    The clinical benefit rate (CBR) is defined as the progression-free rate at 24 weeks (168 days), estimated using Kaplan Meier methodology. All events of disease progression in the primary progression free survival analysis database were to be included, regardless of whether the event occurred while the participant was still taking, or had previously discontinued, study drug. If the participant had not yet progressed then their data was to be censored at the date of the last evaluable disease progression assessment. Participants without post-baseline assessments were to be censored at the date of randomization.

    Time frame: Through the end of Week 24

  3. 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.

    Time frame: Approximately 8 years from randomization

  4. 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.

    Time frame: Approximately 8 years from randomization

07

Results

Posted Apr 4, 2022

Participant flow

A total of 513 subjects enrolled in the study (N=174 to the placebo + C/P arm, and N=339 to the veliparib + C/P arm). Two subjects form each arm (N= 4) were determined not to have a suspected deleterious or deleterious mutation in BRCA1/2 and were excluded from the ITT population \[ITT Population (N=509); Placebo + C/P arm (N=172), and Veliparib + C/P arm (N=337)\]. Of the 4 subjects, 3 subjects received treatment and later discontinued due to disease progression.

Participant flow — Overall Study
MilestonePlacebo + C/PVeliparib + C/P
Started174339
Itt population172337
Completed00
Not completed174339
Withdrew: Adverse event- related to progression410
Withdrew: Adverse event- not related to progression722
Withdrew: Withdrew consent1328
Withdrew: Lost to follow-up22
Withdrew: Sponsor discontinued study329
Withdrew: Progressive disease per protocol125224
Withdrew: Other, not specified1722
Withdrew: Randomized but not treated10
Withdrew: Determined not to have a suspected deleterious or deleterious mutation in brca1/222

Outcome measures

PrimaryProgression-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.

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
Reported as:
Median · months
Progression-Free Survival (PFS)
monthsPlacebo + C/PVeliparib + C/P
Progression-Free Survival (PFS)12.6 (10.6 to 14.4)14.6 (12.5 to 17.7)
Statistical analysis
  • Placebo + C/P vs Veliparib + C/P · Log-rank test · p = 0.003
  • Placebo + C/P vs Veliparib + C/P · Stratified Cox proportional hazards · p = 0.003 · Stratified cox proportional hazards: 0.728 · 95% CI 0.590 to 0.900
SecondaryOverall 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.

Time frame:
Up to 84.5 and 81.8 months for Placebo and Veliparib, respectively.
Reported as:
Median · months
Overall Survival (OS)
monthsPlacebo + C/PVeliparib + C/P
Overall Survival (OS)28.2 (24.7 to 32.8)32.4 (27.4 to 38.1)
Statistical analysis
  • Placebo + C/P vs Veliparib + C/P · Log Rank · p = 0.410
  • Placebo + C/P vs Veliparib + C/P · Stratified Cox proportional hazards · p = 0.410 · Stratified cox proportional hazards: 0.914 · 95% CI 0.737 to 1.333
SecondaryClinical Benefit Rate (CBR)

The clinical benefit rate (CBR) is defined as the progression-free rate at 24 weeks (168 days), estimated using Kaplan Meier methodology. All events of disease progression in the primary progression free survival analysis database were to be included, regardless of whether the event occurred while the participant was still taking, or had previously discontinued, study drug. If the participant had not yet progressed then their data was to be censored at the date of the last evaluable disease progression assessment. Participants without post-baseline assessments were to be censored at the date of randomization.

Time frame:
Through the end of Week 24
Reported as:
Number · percentage of participants
Clinical Benefit Rate (CBR)
percentage of participantsPlacebo + C/PVeliparib + C/P
Clinical Benefit Rate (CBR)93.2 (89.5 to 95.7)90.7 (87.9 to 92.9)
Statistical analysis
  • Placebo + C/P vs Veliparib + C/P · Cochran-Mantel-Haenszel · p = 0.202 (Nominal P value is from Cochran-Mantel-Haenszel test stratified by ER/PgR status and prior platinum therapy use.)
SecondaryObjective 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.

Time frame:
Approximately 8 years from randomization
Reported as:
Number · percentage of participants
Objective Response Rate (ORR)
percentage of participantsPlacebo + C/PVeliparib + C/P
Objective Response Rate (ORR)74.1 (66.1 to 81.1)75.8 (70.4 to 80.6)
Statistical analysis
  • Placebo + C/P vs Veliparib + C/P · Cochran-Mantel-Haenszel · p = 0.715 (Nominal P value is from Cochran-Mantel-Haenszel test stratified by ER/PgR status and prior platinum therapy use.)
SecondaryProgression-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.

Time frame:
Approximately 8 years from randomization
Reported as:
Median · months
Progression-Free Survival on Subsequent Therapy (PFS2)
monthsPlacebo + C/PVeliparib + C/P
Progression-Free Survival on Subsequent Therapy (PFS2)17.4 (16.0 to 20.7)21.5 (19.9 to 25.3)
Statistical analysis
  • Placebo + C/P vs Veliparib + C/P · Log Rank · p = 0.004
  • Placebo + C/P vs Veliparib + C/P · Stratified Cox proportional hazards · p = 0.004 · Stratified cox proportional hazards: 0.737 · 95% CI 0.597 to 0.908Stratified by prior platinum therapy (yes vs no) and receptor status (ER and/or PgR positive vs ER/PgR negative).

Adverse events

Collected over All-cause mortality were reported from enrollment to the end of study, median time on follow up was 84.5 and 81.8 months for Placebo + C/P and Veliparib + C/P, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 115.0 and 117.5 days for Placebo + C/P and Veliparib + C/P, respectively.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo + C/P129/174 (74.1%)68/174 (39.1%)169/174 (97.1%)
Veliparib + C/P244/339 (72%)135/339 (39.8%)332/339 (97.9%)
Most frequent serious events
Showing 10 of 155
Most frequent serious events
EventPlacebo + C/PVeliparib + C/P
MALIGNANT NEOPLASM PROGRESSIONNeoplasms benign, malignant and unspecified (incl cysts and polyps)11/17419/339
ANAEMIABlood and lymphatic system disorders5/17416/339
THROMBOCYTOPENIABlood and lymphatic system disorders5/17414/339
FEBRILE NEUTROPENIABlood and lymphatic system disorders3/17411/339
PYREXIAGeneral disorders4/1749/339
NEUTROPENIABlood and lymphatic system disorders0/1748/339
SEPSISInfections and infestations4/1744/339
METASTASES TO CENTRAL NERVOUS SYSTEMNeoplasms benign, malignant and unspecified (incl cysts and polyps)4/1741/339
PNEUMONIAInfections and infestations2/1747/339
NAUSEAGastrointestinal disorders2/1746/339
Most frequent other events
Showing 10 of 89
Most frequent other events
EventPlacebo + C/PVeliparib + C/P
NEUTROPENIABlood and lymphatic system disorders156/174292/339
THROMBOCYTOPENIABlood and lymphatic system disorders118/174257/339
ANAEMIABlood and lymphatic system disorders117/174256/339
NAUSEAGastrointestinal disorders118/174240/339
ALOPECIASkin and subcutaneous tissue disorders87/174182/339
FATIGUEGeneral disorders90/174168/339
PERIPHERAL SENSORY NEUROPATHYNervous system disorders89/174158/339
DIARRHOEAGastrointestinal disorders69/174151/339
VOMITINGGastrointestinal disorders72/174118/339
LEUKOPENIABlood and lymphatic system disorders65/174133/339

Baseline characteristics

Age, Continuous
Age, Continuous(years)Placebo + C/PVeliparib + C/PTotal
Mean46.8 ± 10.8146.8 ± 10.7346.8 ± 10.75
Sex: Female, Male
Sex: Female, Male(Participants)Placebo + C/PVeliparib + C/PTotal
Female169333502
Male347
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Placebo + C/PVeliparib + C/PTotal
White153294447
Black or African American61420
Asian122436
American Indian or Alaska Native033
Native Hawaiian or Pacific Islander000
Multiple123
08

Study locations

219 sites
  • 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
    Saint 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 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
  • Ordensklinikum Linz GmbH Elisabethinen /ID# 126185
    Linz, Oberoesterreich 4010, Austria
  • Medizinische Universitaet Graz /ID# 126450
    Graz, Steiermark 8036, Austria
  • Medizinische Universitaet Wien /ID# 126184
    Vienna, Wien 1090, Austria
  • Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 126449
    Salzburg, 5020, Austria
  • Bobruysk Interdistrict Onco. /ID# 137729
    Bobruisk, 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, Bruxelles-Capitale 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
    Brugge, 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
  • Duplicate_Jewish General Hospital /ID# 124880
    Montreal, Quebec H3T 1E2, Canada
  • CHUM - Notre-Dame Hospital /ID# 124879
    Montréal, Quebec H2X 0A9, Canada
  • Duplicate_CHUQ-Hospital St. Sacrement /ID# 124881
    Quebec City, Quebec G1S 4L8, Canada
  • Hospital Clinico Vina del Mar /ID# 130100
    Vina Del Mar, Valparaíso 2520612, Chile
  • Hospital Clinico Vina del Mar /ID# 148502
    Vina Del Mar, 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
  • Instituto Medico de Alta Tecnologia Oncomédica S.A /ID# 129211
    Monteria, Cordoba 230002, 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
  • 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 Kralove, 500 05, Czechia
  • Fakultni nemocnice Olomouc /ID# 124885
    Olomouc, 779 00, Czechia

Showing the first 100 of 219 sites across 37 countries.

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References and documents

Publications

  • Stodtmann S, Eckert D, Joshi R, Nuthalapati S, Ratajczak CK, Menon R, Mensing S, Xiong H. Exposure-Response Model With Time-Varying Predictors to Estimate the Effects of Veliparib in Combination With Carboplatin/Paclitaxel and as Monotherapy: Veliparib Phase 3 Study in BRCA-Mutated Advanced Breast Cancer (BROCADE3) Trial. J Clin Pharmacol. 2022 Oct;62(10):1236-1246. doi: 10.1002/jcph.2061. Epub 2022 May 5. PubMed 35403245 ↗
  • 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. PubMed 34917174 ↗
  • 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. PubMed 34243076 ↗
  • 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. PubMed 34131001 ↗
  • 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. PubMed 32861273 ↗

Study documents

  • Study protocol · Jul 23, 2020
  • Statistical analysis plan · May 30, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Sap, Csr

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02163694
Lead sponsor
AbbVie
Responsible party
Sponsor
First posted
Jun 16, 2014
Start date
Apr 8, 2014
Primary completion
Apr 5, 2019
Completion
Jan 25, 2024
Results posted
Apr 4, 2022
Last update
Feb 19, 2025

Study contacts

ABBVIE INC.
study director · AbbVie

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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