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CompletedNCT01506609Updated Oct 25, 2021Results posted

Study Evaluating Efficacy And Tolerability Of Veliparib in Combination With Temozolomide (TMZ) or In Combination With Carboplatin and Paclitaxel Versus Placebo in Participants With Breast Cancer Gene (BRCA)1 and BRCA2 Mutation and Metastatic Breast Cancer

A Phase 2 interventional study of Placebo and Veliparib in Metastatic Breast Cancer, sponsored by AbbVie. Completed at 120 sites in 20 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-25.

Sponsored by AbbVie · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
294
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 oral veliparib in combination with TMZ or in combination with carboplatin and paclitaxel compared to placebo plus carboplatin and paclitaxel in subjects with BRCA1 or BRCA2 mutation and locally recurrent or metastatic breast cancer.

02

Conditions studied

  • Metastatic Breast Cancer

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Keywords

  • PARP
  • TMZ
  • Temodal
  • Carboplatin
  • veliparib
  • BRCA2 mutation carrier
  • Breast cancer
  • Metastatic breast cancer
  • temozolomide
  • BRCA1 mutation carrier
  • ABT-888
  • Paclitaxel
  • Recurrent breast cancer
  • Temodar
  • Locally recurrent
03

In context

Breast Neoplasms

12,543 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 294 is above the median of 72 across 9,302 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

  • Histologically or cytologically confirmed breast cancer that is either locally recurrent or metastatic.
  • Locally recurrent disease must not be amenable to surgical resection or radiation with curative intent.
  • Must have a documented deleterious Breast Cancer Gene BRCA1 or BRCA2 germline mutation.
  • If Human Epidermal Growth Factor Receptor (HER2) positive, subjects must have received and progressed on at least one prior standard HER2 directed therapy or the subject must be ineligible to receive anti-HER2 therapy.
  • Measurable or non-measurable (but radiologically evaluable) disease by RECIST (Response Evaluation Criteria in Solid Tumors) criteria 1.1.
  • Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-2.
  • Subject must have adequate bone marrow, renal and hepatic function.
  • Subject must not be pregnant or plan to conceive a child.

Exclusion criteria

Exclusion Criteria:

  • Received anticancer agent(s) or an investigational agent within 21 days prior to C1D1, or radiotherapy within 28 days prior Cycle 1 Day 1.
  • More than 2 prior lines of cytotoxic chemotherapy.
  • Prior treatment of breast cancer with temozolomide, a platinum agent, or a Poly (ADP ribose) Polymerase (PARP) inhibitor.
  • Prior taxane therapy for metastatic breast cancer.
  • A history of or evidence of brain metastases or leptomeningeal disease.
  • A history of uncontrolled seizure disorder.
  • Pre-existing neuropathy from any cause in excess of Grade 1.
  • Known history of allergic reaction to cremophor/paclitaxel.
  • Clinical significant uncontrolled conditions, active infection, myocardial infarction, stroke, or transient ischemic attack, psychiatric illness/social situations that would limit compliance.
  • Pregnant or breastfeeding.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
294 participants (actual)

Study arms

  • Experimental
    Veliparib with Temozolomide

    Veliparib 40 mg twice daily (BID) Days 1 through 7 plus TMZ 150 to 200 mg/m\^2 QD Days 1 through 5 in each 28-day cycle.

    Drug: Veliparib · Drug: Temozolomide

  • Placebo comparator
    Placebo with Carboplatin and Paclitaxel

    Placebo BID Days 1 through 7 plus carboplatin target area under the curve (mg•min/mL) (AUC) 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m\^2 administered on Day 3 of each 21-day cycle.

    Drug: Placebo · Drug: Carboplatin · Drug: Paclitaxel

  • Experimental
    Veliparib with Carboplatin and Paclitaxel

    Veliparib 80 mg BID Days 1 through 7 plus carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m\^2 administered on Day 3 of each 21-day cycle.

    Drug: Veliparib · Drug: Carboplatin · Drug: Paclitaxel

Interventions

  • DrugPlacebo
  • DrugVeliparib

    Also known as: ABT-888

  • DrugCarboplatin
  • DrugTemozolomide

    Also known as: Temodal

  • DrugPaclitaxel

    Also known as: Taxol

06

What researchers measure

Primary outcomes

  1. Progression-Free Survival (PFS)

    PFS is defined as the number of months from the date the participant was randomized to the date of radiographic progression as determined by the central imaging center, or to the date of all cause deaths within 63 days of last tumor assessment if disease progression was not reached.

    Time frame: Radiographic evaluation every 9 weeks, clinical evaluation every cycle (data cutoff date: 04 March 2016); maximum duration of follow up for PFS was 34 months.

Secondary outcomes

  1. Overall Survival (OS)

    Time to death for a given participant was defined as the number of months from the day the participant is randomized to the date of the participant's death. All events of death were included, regardless of whether the event occurs while the participant was still taking study drug, or after the participant discontinued study drug. If a participant had not died, then the data will be censored at the date when the participant was last known to be alive.

    Time frame: From Cycle 1 Day 1 until participant's death or 3 years post discontinuation (data cutoff date: 04 March 2016); maximum duration of follow up for OS was 72 months.

  2. Clinical Benefit Rate (CBR) at Week 18

    CBR: percentage of participants who were progression-free at 18 weeks, defined as complete response (CR), partial response (PR), stable disease (SD) or non-CR/non-disease progression (PD) per Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1. CR: The disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 0 mm. PR: \>= 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters (SOD). PD: \>= 20% increase in the SOD of target lesions, taking as reference the smallest SOD recorded since the treatment started (baseline or after) or the appearance of \>=1 new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SOD since the treatment started (baseline or after).

    Time frame: Week 18

  3. Objective Response Rate (ORR)

    The objective response rate, defined as percentage of participants with a confirmed CR or PR based on RECIST 1.1 criteria. CR: The disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 0 mm. PR: \>= 30% decrease in the sum of diameters of target lesions, taking as reference the baseline SODs.

    Time frame: Radiographic evaluation every 9 weeks, clinical evaluation every cycle (data cutoff date: 04 March 2016); maximum duration of follow up for ORR was 34 months.

  4. Change From Baseline at Week 18 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Chemotherapy-Induced Peripheral Neuropathy Module (EORTC QLQ-CIPN20) Sensory Subscale Score

    EORTC QLQ-CIPN20 sensory subscale score was calculated following the standard scoring algorithm, transformed to a 0 (low quality of life) to 100 (best quality of life) scale. A positive change from baseline indicates improvement.

    Time frame: Baseline, Week 18

07

Results

Posted Oct 25, 2021

Participant flow

Under the original protocol, approximately 4 participants were randomized in a 1:1:1 ratio (Group 1) to 1 of the 3 treatment arms (1 participant in veliparib 40 mg twice daily (BID)+temozolomide (TMZ) arm and a total of 3 participants in either the veliparib 80 mg BID+carboplatin+paclitaxel or the placebo BID+carboplatin+paclitaxel arms) at approximately 3 research sites. Participants randomized under the original protocol were in Group 1, and were not included in the primary efficacy analyses.

Participant flow — Overall Study
MilestoneGroup 1 Placebo + Carboplatin/PaclitaxelGroup 1 Veliparib + Carboplatin/PaclitaxelGroup 1 Veliparib + TMZGroup 2 Placebo + Carboplatin/PaclitaxelGroup 2 Veliparib + Carboplatin/PaclitaxelGroup 2 Veliparib + TMZ
Started211999794
Completed000010
Not completed211999694
Withdrew: Adverse event related to progression000373
Withdrew: Adverse event not related to progression0106105
Withdrew: Withdrawal by subject000977
Withdrew: Lost to follow-up000120
Withdrew: Sponsor discontinued study000220
Withdrew: Progressive disease per protocol100645774
Withdrew: Other, not specified0001073
Withdrew: Missing / unknown reason101442

Outcome measures

PrimaryProgression-Free Survival (PFS)

PFS is defined as the number of months from the date the participant was randomized to the date of radiographic progression as determined by the central imaging center, or to the date of all cause deaths within 63 days of last tumor assessment if disease progression was not reached.

Time frame:
Radiographic evaluation every 9 weeks, clinical evaluation every cycle (data cutoff date: 04 March 2016); maximum duration of follow up for PFS was 34 months.
Reported as:
Median · months
Progression-Free Survival (PFS)
monthsGroup 2 Placebo + Carboplatin/PaclitaxelGroup 2 Veliparib + Carboplatin/PaclitaxelGroup 2 Veliparib + TMZ
Progression-Free Survival (PFS)12.3 (9.3 to 14.5)14.1 (11.5 to 16.2)7.4 (5.9 to 8.5)
Statistical analysis
  • Group 2 Placebo + Carboplatin/Paclitaxel vs Group 2 Veliparib + Carboplatin/Paclitaxel · Log Rank · p = 0.227 · Hazard ratio (hr): 0.789 · 95% CI 0.536 to 1.162
  • Group 2 Placebo + Carboplatin/Paclitaxel vs Group 2 Veliparib + TMZ · Log Rank · p = 0.001 · Hazard ratio (hr): 1.858 · 95% CI 1.278 to 2.702
SecondaryOverall Survival (OS)

Time to death for a given participant was defined as the number of months from the day the participant is randomized to the date of the participant's death. All events of death were included, regardless of whether the event occurs while the participant was still taking study drug, or after the participant discontinued study drug. If a participant had not died, then the data will be censored at the date when the participant was last known to be alive.

Time frame:
From Cycle 1 Day 1 until participant's death or 3 years post discontinuation (data cutoff date: 04 March 2016); maximum duration of follow up for OS was 72 months.
Reported as:
Median · months
Overall Survival (OS)
monthsGroup 2 Placebo + Carboplatin/PaclitaxelGroup 2 Veliparib + Carboplatin/PaclitaxelGroup 2 Veliparib + TMZ
Overall Survival (OS)25.4 (18.3 to 32.1)28.3 (24.9 to 33.4)19.1 (14.3 to 21.3)
Statistical analysis
  • Group 2 Placebo + Carboplatin/Paclitaxel vs Group 2 Veliparib + Carboplatin/Paclitaxel · Log Rank · p = 0.368 · Hazard ratio (hr): 0.848 · 95% CI 0.590 to 1.218
  • Group 2 Placebo + Carboplatin/Paclitaxel vs Group 2 Veliparib + TMZ · Log Rank · p = 0.017 · Hazard ratio (hr): 1.512 · 95% CI 1.074 to 2.127
SecondaryClinical Benefit Rate (CBR) at Week 18

CBR: percentage of participants who were progression-free at 18 weeks, defined as complete response (CR), partial response (PR), stable disease (SD) or non-CR/non-disease progression (PD) per Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1. CR: The disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 0 mm. PR: \>= 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters (SOD). PD: \>= 20% increase in the SOD of target lesions, taking as reference the smallest SOD recorded since the treatment started (baseline or after) or the appearance of \>=1 new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SOD since the treatment started (baseline or after).

Time frame:
Week 18
Reported as:
Number · percentage of participants
Clinical Benefit Rate (CBR) at Week 18
percentage of participantsGroup 2 Placebo + Carboplatin/PaclitaxelGroup 2 Veliparib + Carboplatin/PaclitaxelGroup 2 Veliparib + TMZ
Clinical Benefit Rate (CBR) at Week 1887.0 (78.3 to 92.4)90.7 (82.2 to 95.2)73.0 (62.2 to 81.2)
Statistical analysis
  • Group 2 Placebo + Carboplatin/Paclitaxel vs Group 2 Veliparib + Carboplatin/Paclitaxel · Cochran-Mantel-Haenszel · p = 0.434 (P-value is from Cochran-Mantel-Haenszel test stratified by estrogen receptor/progesterone receptor status and prior cytotoxic therapy use.)
  • Group 2 Placebo + Carboplatin/Paclitaxel vs Group 2 Veliparib + TMZ · Cochran-Mantel-Haenszel · p = 0.019 (P-value is from Cochran-Mantel-Haenszel test stratified by estrogen receptor/progesterone receptor status and prior cytotoxic therapy use.)
SecondaryObjective Response Rate (ORR)

The objective response rate, defined as percentage of participants with a confirmed CR or PR based on RECIST 1.1 criteria. CR: The disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 0 mm. PR: \>= 30% decrease in the sum of diameters of target lesions, taking as reference the baseline SODs.

Time frame:
Radiographic evaluation every 9 weeks, clinical evaluation every cycle (data cutoff date: 04 March 2016); maximum duration of follow up for ORR was 34 months.
Reported as:
Number · percentage of participants
Objective Response Rate (ORR)
percentage of participantsGroup 2 Placebo + Carboplatin/PaclitaxelGroup 2 Veliparib + Carboplatin/PaclitaxelGroup 2 Veliparib + TMZ
Objective Response Rate (ORR)61.3 (49.7 to 71.9)77.8 (66.4 to 86.7)28.6 (18.4 to 40.6)
Statistical analysis
  • Group 2 Placebo + Carboplatin/Paclitaxel vs Group 2 Veliparib + Carboplatin/Paclitaxel · Cochran-Mantel-Haenszel · p = 0.027 (P-value is from Cochran-Mantel-Haenszel test stratified by estrogen receptor/progesterone receptor status and prior cytotoxic therapy use.)
  • Group 2 Placebo + Carboplatin/Paclitaxel vs Group 2 Veliparib + TMZ · Cochran-Mantel-Haenszel · p = < 0.001 (P-value is from Cochran-Mantel-Haenszel test stratified by estrogen receptor/progesterone receptor status and prior cytotoxic therapy use.)
SecondaryChange From Baseline at Week 18 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Chemotherapy-Induced Peripheral Neuropathy Module (EORTC QLQ-CIPN20) Sensory Subscale Score

EORTC QLQ-CIPN20 sensory subscale score was calculated following the standard scoring algorithm, transformed to a 0 (low quality of life) to 100 (best quality of life) scale. A positive change from baseline indicates improvement.

Time frame:
Baseline, Week 18
Reported as:
Mean · score on a scale
Change From Baseline at Week 18 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Chemotherapy-Induced Peripheral Neuropathy Module (EORTC QLQ-CIPN20) Sensory Subscale Score
score on a scaleGroup 2 Placebo + Carboplatin/PaclitaxelGroup 2 Veliparib + Carboplatin/Paclitaxel
Change From Baseline at Week 18 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Chemotherapy-Induced Peripheral Neuropathy Module (EORTC QLQ-CIPN20) Sensory Subscale Score13.94 ± 14.12311.24 ± 13.954
Statistical analysis
  • Group 2 Placebo + Carboplatin/Paclitaxel vs Group 2 Veliparib + Carboplatin/Paclitaxel · ANCOVA · p = 0.354 (ANCOVA with treatment arm and baseline value as covariate.) · Least squares (ls) mean of difference: -2.302 · 95% CI -7.20 to 2.60

Adverse events

Collected over All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Group 1 Placebo + Carboplatin/Paclitaxel2/2 (100%)0/2 (0%)2/2 (100%)
Group 1 Veliparib + Carboplatin/Paclitaxel1/1 (100%)0/1 (0%)1/1 (100%)
Group 1 Veliparib + TMZ1/1 (100%)0/1 (0%)1/1 (100%)
Group 2 Placebo + Carboplatin/Paclitaxel65/96 (67.7%)26/96 (27.1%)93/96 (96.9%)
Group 2 Veliparib + Carboplatin/Paclitaxel59/93 (63.4%)32/93 (34.4%)93/93 (100%)
Group 2 Veliparib + TMZ76/93 (81.7%)16/93 (17.2%)91/93 (97.8%)
Most frequent serious events
Showing 10 of 69
Most frequent serious events
EventGroup 1 Placebo + Carboplatin/PaclitaxelGroup 1 Veliparib + Carboplatin/PaclitaxelGroup 1 Veliparib + TMZGroup 2 Placebo + Carboplatin/PaclitaxelGroup 2 Veliparib + Carboplatin/PaclitaxelGroup 2 Veliparib + TMZ
FEBRILE NEUTROPENIABlood and lymphatic system disorders0/20/10/12/967/931/93
MALIGNANT NEOPLASM PROGRESSIONNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/20/10/10/965/934/93
PYREXIAGeneral disorders0/20/10/12/964/930/93
ABDOMINAL PAINGastrointestinal disorders0/20/10/10/963/931/93
ANAEMIABlood and lymphatic system disorders0/20/10/10/962/930/93
THROMBOCYTOPENIABlood and lymphatic system disorders0/20/10/12/962/931/93
BREAST CELLULITISInfections and infestations0/20/10/10/962/930/93
DIARRHOEAGastrointestinal disorders0/20/10/12/961/930/93
DEVICE RELATED INFECTIONInfections and infestations0/20/10/12/960/930/93
BREAST CANCER METASTATICNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/20/10/12/960/930/93
Most frequent other events
Showing 10 of 95
Most frequent other events
EventGroup 1 Placebo + Carboplatin/PaclitaxelGroup 1 Veliparib + Carboplatin/PaclitaxelGroup 1 Veliparib + TMZGroup 2 Placebo + Carboplatin/PaclitaxelGroup 2 Veliparib + Carboplatin/PaclitaxelGroup 2 Veliparib + TMZ
ANAEMIABlood and lymphatic system disorders2/21/10/149/9653/9326/93
LEUKOPENIABlood and lymphatic system disorders1/21/10/127/9628/9316/93
NEUTROPENIABlood and lymphatic system disorders2/21/10/170/9668/9346/93
THROMBOCYTOPENIABlood and lymphatic system disorders1/21/11/165/9666/9372/93
CONSTIPATIONGastrointestinal disorders0/21/10/128/9638/9338/93
DIARRHOEAGastrointestinal disorders0/21/11/125/9637/9319/93
DYSPEPSIAGastrointestinal disorders1/21/10/115/969/935/93
MELAENAGastrointestinal disorders0/20/11/10/961/931/93
NAUSEAGastrointestinal disorders1/21/11/156/9666/9369/93
STOMATITISGastrointestinal disorders0/21/10/111/9611/935/93

Baseline characteristics

Age, Customized
Age, Customized(Participants)Group 1 Placebo + Carboplatin/PaclitaxelGroup 1 Veliparib + Carboplatin/PaclitaxelGroup 1 Veliparib + TMZGroup 2 Placebo + Carboplatin/PaclitaxelGroup 2 Veliparib + Carboplatin/PaclitaxelGroup 2 Veliparib + TMZTotal
< 45 years210474941140
45 to 64 years001494746143
>= 65 years00031711
Sex: Female, Male
Sex: Female, Male(Participants)Group 1 Placebo + Carboplatin/PaclitaxelGroup 1 Veliparib + Carboplatin/PaclitaxelGroup 1 Veliparib + TMZGroup 2 Placebo + Carboplatin/PaclitaxelGroup 2 Veliparib + Carboplatin/PaclitaxelGroup 2 Veliparib + TMZTotal
Female211979592288
Male0002226
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Group 1 Placebo + Carboplatin/PaclitaxelGroup 1 Veliparib + Carboplatin/PaclitaxelGroup 1 Veliparib + TMZGroup 2 Placebo + Carboplatin/PaclitaxelGroup 2 Veliparib + Carboplatin/PaclitaxelGroup 2 Veliparib + TMZTotal
Hispanic or Latino00067518
No Ethnicity211939089276
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Group 1 Placebo + Carboplatin/PaclitaxelGroup 1 Veliparib + Carboplatin/PaclitaxelGroup 1 Veliparib + TMZGroup 2 Placebo + Carboplatin/PaclitaxelGroup 2 Veliparib + Carboplatin/PaclitaxelGroup 2 Veliparib + TMZTotal
White211939283272
Black000431017
Asian0000112
Native Hawaiian or Other Pacific Islander0000101
Other, Not Specified0002002
08

Study locations

120 sites
  • University of Alabama at Birmingham - Main /ID# 62994
    Birmingham, Alabama 35233, United States
  • Banner MD Anderson Cancer Ctr /ID# 118695
    Gilbert, Arizona 85234, United States
  • University of Arkansas for Medical Sciences /ID# 60750
    Little Rock, Arkansas 72205, United States
  • Moore UC San Diego Cancer Center /ID# 60754
    La Jolla, California 92093, United States
  • The Angeles Clinic and Researc /ID# 60743
    Los Angeles, California 90025, United States
  • Stanford University School of Med /ID# 65488
    Stanford, California 94305-2200, United States
  • Cedars-Sinai Medical Center - West Hollywood /ID# 60760
    West Hollywood, California 90048, United States
  • Univ of Colorado Cancer Center /ID# 60751
    Aurora, Colorado 80045, United States
  • Lynn Cancer Institute, Boca /ID# 60749
    Boca Raton, Florida 33486, United States
  • Holy Cross Hospital /ID# 62995
    Fort Lauderdale, Florida 33308, United States
  • Moffitt Cancer Center /ID# 60746
    Tampa, Florida 33612-9416, United States
  • Florida Cancer Specialists - East /ID# 60762
    West Palm Beach, Florida 33401, United States
  • University of Illinois - Chicago /ID# 106175
    Chicago, Illinois 60607, United States
  • Northwestern University Feinberg School of Medicine /ID# 60755
    Chicago, Illinois 60611-2927, United States
  • Rush University Medical Center /ID# 65489
    Chicago, Illinois 60612, United States
  • Midwestern Regional CTC /ID# 60744
    Zion, Illinois 60099, United States
  • Johns Hopkins University /ID# 60759
    Baltimore, Maryland 21287, United States
  • Massachusetts General Hospital /ID# 64582
    Boston, Massachusetts 02114, United States
  • Dana-Farber Cancer Institute /ID# 93833
    Boston, Massachusetts 02215, United States
  • William Beaumont Hospital /ID# 95417
    Royal Oak, Michigan 48073-6710, United States
  • Washington University-School of Medicine /ID# 62724
    Saint Louis, Missouri 63110, United States
  • Beth Israel Medical Center /ID# 87993
    New York, New York 10003, United States
  • Memorial Sloan Kettering Cancer Center-Koch Center /ID# 63222
    New York, New York 10065-6007, United States
  • Duke University Medical Center /ID# 60747
    Durham, North Carolina 27710-3000, United States
  • Penn State University and Milton S. Hershey Medical Center /ID# 62723
    Hershey, Pennsylvania 17033, United States
  • University of Pennsylvania /ID# 60753
    Philadelphia, Pennsylvania 19104-5502, United States
  • University of Pittsburgh MC /ID# 60758
    Pittsburgh, Pennsylvania 15260, United States
  • University of Pittsburgh MC /ID# 65486
    Pittsburgh, Pennsylvania 15260, United States
  • Medical University of South Carolina /ID# 60752
    Charleston, South Carolina 29425, United States
  • The West Clinic /ID# 65487
    Memphis, Tennessee 38120, United States
  • The West Clinic /ID# 94599
    Memphis, Tennessee 38120, United States
  • The West Clinic /ID# 94600
    Memphis, Tennessee 38120, United States
  • UT Southwestern Medical Center /ID# 60745
    Dallas, Texas 75390-7208, United States
  • Houston Methodist Hospital - Scurlock Tower /ID# 60742
    Houston, Texas 77030, United States
  • Coiba /Id# 65219
    Berazategui, Buenos Aires, 1884, Argentina
  • ISIS Centro Especializado /ID# 65226
    Santa Fe, 3000, Argentina
  • The Prince of Wales Hospital /ID# 63271
    Randwick, New South Wales 2031, Australia
  • Southern Medical Day Care Ctr /ID# 63274
    Wollongong, New South Wales 2500, Australia
  • Mater Misericordiae Limited /ID# 63276
    South Brisbane, Queensland 4101, Australia
  • Royal Adelaide Hospital /ID# 63280
    Adelaide, South Australia 5000, Australia
  • Royal Hobart Hospital /ID# 63279
    Hobart, Tasmania 7000, Australia
  • Peter MacCallum Cancer Ctr /ID# 63272
    Melbourne, Victoria 3000, Australia
  • Royal Melbourne Hospital /ID# 63278
    Parkville, Victoria 3050, Australia
  • Mount Hospital /ID# 65262
    Perth, Western Australia 6000, Australia
  • Cliniques Universitaires Saint Luc /ID# 96135
    Woluwe-Saint-Lambert, Bruxelles-Capitale 1200, Belgium
  • Grand Hôpital de Charleroi /ID# 96136
    Charleroi, Hainaut 6000, Belgium
  • AZ St-Jan Brugge-Oostende AV /ID# 107315
    Brugge, West-Vlaanderen 8000, Belgium
  • UZ Antwerp /ID# 96945
    Edegem, 2650, Belgium
  • UZ Leuven /ID# 96138
    Leuven, 3000, Belgium
  • CHU UCL Namur /ID# 110595
    Namur, 5000, Belgium
  • Hospital Bruno Born / Sociedade Beneficencia e Caridade de Lajeado /ID# 65247
    Lajeado, Rio Grande Do Sul 95900-000, Brazil
  • Irmandade da Santa Casa de /ID# 65244
    Porto Alegre, Rio Grande Do Sul 90020-090, Brazil
  • Hospital de Clinicas de Porto Alegre /ID# 65242
    Porto Alegre, Rio Grande Do Sul 90035-903, Brazil
  • Sunnybrook Health Sciences Ctr /ID# 77373
    Toronto, Ontario M4N 3M5, Canada
  • Jewish General Hospital /ID# 69893
    Montreal, Quebec H3T 1E2, Canada
  • CHUM - Notre-Dame Hospital /ID# 67862
    Montréal, Quebec H2X 0A9, Canada
  • CHUQ-Hospital St. Sacrement /ID# 68902
    Quebec City, Quebec G1S 4L8, Canada
  • Masarykuv onkologicky ustav /ID# 65170
    Brno, 656 53, Czechia
  • Palacky University /ID# 63923
    Olomouc, 779 00, Czechia
  • Vseobecna Fakultni Nemocnice /ID# 65172
    Prague, 128 08, Czechia
  • Vejle Sygehus /ID# 65173
    Vejle, Syddanmark 7100, Denmark
  • Rigshospitalet, Finsen Centre /ID# 67822
    Copenhagen, 2100, Denmark
  • Docrates Cancer Center /ID# 63924
    Helsinki, 00180, Finland
  • Tampere University Hospital /ID# 102417
    Tampere, 33521, Finland
  • Hopital Universitaire Purpan /ID# 98815
    Toulouse, Haute-Garonne 31059, France
  • Institut Curie /ID# 63926
    Paris CEDEX 05, Ile-de-France 75248, France
  • Institut de Cancer de l'Ouest /ID# 63927
    St Herblain CEDEX, Loire-Atlantique 44805, France
  • Centre Leon Berard /ID# 106675
    Lyon CEDEX 08, Rhone 69373, France
  • Pays-Basque Ctr Oncology/Radio /ID# 65176
    Bayonne, 64100, France
  • Institut Paoli-Calmettes /ID# 65175
    Marseille, 13273, France
  • Hopital Rene Huguenin /ID# 65177
    Saint-cloud, 92210, France
  • Centre Paul Strauss /ID# 100275
    Strasbourg, 67065, France
  • Bajcsy-Zsilinszky Korhaz /ID# 65179
    Budapest, 1106, Hungary
  • Debreceni Egyetem Klinikai Kozpont /ID# 65178
    Debrecen, 4032, Hungary
  • Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz /ID# 63928
    Szolnok, 5004, Hungary
  • Rabin Medical Center /ID# 63929
    Petakh Tikva, Tel-Aviv 4941492, Israel
  • Soroka University Medical Center /ID# 65180
    Be'er Sheva, 84101, Israel
  • Assaf Harofeh Medical Center /ID# 65181
    Be'er Ya'akov, 70300, Israel
  • Rambam Health Care Campus /ID# 63930
    Haifa, 3109601, Israel
  • Shaare Zedek Medical Center /ID# 116575
    Jerusalem, 91031, Israel
  • Gastroenterology Institute, Division of Medicine /ID# 63931
    Jerusalem, 91120, Israel
  • Sheba Medical Center /ID# 63932
    Ramat Gan, 5239424, Israel
  • Kaplan Medical Center /ID# 63933
    Rehovot, 76100, Israel
  • Erasmus Medisch Centrum /ID# 96275
    Rotterdam, 3015 CE, Netherlands
  • Haukeland University Hospital /ID# 67982
    Bergen, Hordaland 5021, Norway
  • Mrukmed. Lekarz Beata Madej Mruk i Partner /ID# 94975
    Rzeszów, Podkarpackie 35-021, Poland
  • Centrum Onkologii Lukaszczyka /ID# 73393
    Bydgoszcz, 85-796, Poland
  • Olsztynski Osrodek Onkologi /ID# 71060
    Olsztyn, 10-513, Poland
  • NZOZ Centrum Medyczne HCP /ID# 68102
    Poznan, 61-485, Poland
  • Wielkopolskie Centrum Onkologi /ID# 71061
    Poznan, 61-866, Poland
  • S.C. lanuli Med Consult SRL /ID# 106955
    Bucharest, 020962, Romania
  • lnstitutul Oncologic Trestiore /ID# 96742
    Bucharest, 022328, Romania
  • Spitalul Clinic Judetean de Urgenta /ID# 96741
    Cluj, 400006, Romania
  • Inst Oncology Prof. Chiricuta /ID# 96740
    Cluj, 400010, Romania
  • Sc Oncolab Srl /Id# 96745
    Craiova, 200385, Romania
  • Federal State Budgetary Scientific Institution N.N. Blokhin Russian Cancer Resea /ID# 65263
    Moscow, Moskva 115478, Russian Federation
  • Chelyabinsk Reg Clin Oncology /ID# 63938
    Chelyabinsk, 454087, Russian Federation
  • State Regional Budgetary Healthcare Institution " Murmansk Regional Oncology Dis /ID# 102415
    Murmansk, 183047, Russian Federation
  • City Clinical Hospital 1 /ID# 102416
    Novosibirsk, 630075, Russian Federation
  • Pyatigorsk Oncology Dispensary /ID# 65264
    Pyatigorsk, 357502, Russian Federation

Showing the first 100 of 120 sites across 20 countries.

09

References and documents

Publications

  • Han HS, Dieras V, Robson M, Palacova M, Marcom PK, Jager A, Bondarenko I, Citrin D, Campone M, Telli ML, Domchek SM, Friedlander M, Kaufman B, Garber JE, Shparyk Y, Chmielowska E, Jakobsen EH, Kaklamani V, Gradishar W, Ratajczak CK, Nickner C, Qin Q, Qian J, Shepherd SP, Isakoff SJ, Puhalla S. Veliparib with temozolomide or carboplatin/paclitaxel versus placebo with carboplatin/paclitaxel in patients with BRCA1/2 locally recurrent/metastatic breast cancer: randomized phase II study. Ann Oncol. 2018 Jan 1;29(1):154-161. doi: 10.1093/annonc/mdx505. PubMed 29045554 ↗
  • Isakoff SJ, Puhalla S, Domchek SM, Friedlander M, Kaufman B, Robson M, Telli ML, Dieras V, Han HS, Garber JE, Johnson EF, Maag D, Qin Q, Giranda VL, Shepherd SP. A randomized Phase II study of veliparib with temozolomide or carboplatin/paclitaxel versus placebo with carboplatin/paclitaxel in BRCA1/2 metastatic breast cancer: design and rationale. Future Oncol. 2017 Feb;13(4):307-320. doi: 10.2217/fon-2016-0412. Epub 2016 Oct 14. PubMed 27739325 ↗

Study documents

  • Study protocol · Jun 7, 2019
  • Statistical analysis plan · Apr 7, 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 Oct 25, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01506609
Lead sponsor
AbbVie
Responsible party
Sponsor
First posted
Jan 10, 2012
Start date
Jan 23, 2012
Primary completion
Dec 13, 2018
Completion
Sep 2, 2020
Results posted
Oct 25, 2021
Last update
Oct 25, 2021

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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