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Veliparib With or Without Carboplatin in Treating Patients With Stage III-IV Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01149083
Recruitment Status : Active, not recruiting
First Posted : June 23, 2010
Last Update Posted : March 23, 2018
Information provided by (Responsible Party):
National Cancer Institute (NCI)

June 22, 2010
June 23, 2010
March 23, 2018
June 30, 2010
December 31, 2018   (Final data collection date for primary outcome measure)
Response rate as measured by RECIST version 1.1 [ Time Frame: Up to 4 years ]
Response rate as measured by RECIST
Complete list of historical versions of study NCT01149083 on Archive Site
  • Progression-free survival [ Time Frame: From start of treatment to time of progression or death, whichever occurs first, assessed up to 4 years ]
    Compared between arms using the log-rank test. Analyzed using Kaplan-Meier plots and multivariate Cox regression.
  • Toxicity graded according to the NCI CTCAE version 4.0 [ Time Frame: Up to 4 years ]
    Assessed and summarized with descriptive statistics.
  • Progression-free survival
  • Toxicity
  • Pharmacokinetics
Not Provided
Not Provided
Veliparib With or Without Carboplatin in Treating Patients With Stage III-IV Breast Cancer
Phase II Trial of Single Agent ABT-888 With Post-Progression Therapy of ABT-888 in Combination With Carboplatin in Patients With Stage IV BRCA-Associated Breast Cancer
This phase II trial studies how well veliparib with or without carboplatin works in treating patients with stage III-IV breast cancer. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether veliparib is more effective with or without carboplatin in treating breast cancer.


I. To evaluate the efficacy of single agent ABT-888 (veliparib) (NSC 737664) in breast cancer (BRCA) carriers with metastatic breast cancer based on response rate (Response Evaluation Criteria In Solid Tumors [RECIST] criteria).


I. To conduct subset analysis on BRCA1 vs. BRCA2 and hormone receptor status. II. To evaluate progression-free survival of patients on single-agent ABT-888. III. To further describe the safety and tolerability of ABT-888 (NSC 737664) as a single agent and in combination with carboplatin for BRCA-associated breast cancer.

IV. To evaluate the pharmacokinetics of ABT-888 (NSC 737664) alone and in combination with carboplatin.

V. To assess the relationship between the level of poly adenosine diphosphate (ADP) ribose polymerase (PARP) inhibition by ABT-888 and biomarkers of deoxyribonucleic acid (DNA) damage in peripheral blood mononuclear cell (PBMC's) and in tumor.

VI. To explore the relationship between biomarkers of drug effect and progression-free survival.

VII. To evaluate the efficacy and safety of the combination of carboplatin and ABT-888 in patients who have failed single agent ABT-888.

VIII. To conduct subset analysis on BRCA1 vs. BRCA2 and hormone receptor status.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive veliparib orally (PO) twice daily (BID) on days 1-21.

ARM II: Patients receive carboplatin intravenously (IV) over 30 minutes on day 1 and veliparib as in Arm I.

In both arms, treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3-6 months.

Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • BRCA1 Mutation Carrier
  • BRCA2 Mutation Carrier
  • Recurrent Breast Carcinoma
  • Stage IIIB Breast Cancer AJCC v7
  • Stage IIIC Breast Cancer AJCC v7
  • Stage IV Breast Cancer AJCC v6 and v7
  • Drug: Carboplatin
    Given IV
    Other Names:
    • Blastocarb
    • Carboplat
    • Carboplatin Hexal
    • Carboplatino
    • Carbosin
    • Carbosol
    • Carbotec
    • CBDCA
    • Displata
    • Ercar
    • JM-8
    • Nealorin
    • Novoplatinum
    • Paraplatin
    • Paraplatin AQ
    • Paraplatine
    • Platinwas
    • Ribocarbo
  • Other: Laboratory Biomarker Analysis
    Correlative studies
  • Drug: Veliparib
    Given PO
    Other Names:
    • ABT-888
    • PARP-1 inhibitor ABT-888
  • Experimental: Arm I (veliparib)
    Patients receive veliparib PO BID on days 1-21.
    • Other: Laboratory Biomarker Analysis
    • Drug: Veliparib
  • Experimental: Arm II (veliparib, carboplatin)
    Patients receive carboplatin IV over 30 minutes on day 1 and veliparib as in Arm I.
    • Drug: Carboplatin
    • Other: Laboratory Biomarker Analysis
    • Drug: Veliparib
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Active, not recruiting
Not Provided
December 31, 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients must be female, and must have histologically confirmed breast cancer that is metastatic or locally advanced, unresectable and for which standard curative measures do not exist or are no longer effective
  • Patient must have a known deleterious BRCA mutation confirmed by report from a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory (generally Myriad Genetics Laboratory)
  • Measurable disease by RECIST criteria; (evaluable disease is allowed only for the safety lead-in phase)
  • Prior chemotherapy regimens for metastatic disease are completed, at least 3 weeks prior to starting therapy; prior radiation and hormonal treatment must be completed at least 1 week prior to starting therapy
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Life expectancy greater than four months
  • Absolute neutrophil count (ANC) >= 1,500/mcL
  • Platelet count >= 100,000/mcL
  • Total bilirubin =< 1.5 times institutional upper limit of normal
  • Aspartate aminotransferase (AST) serum glutamic oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT) serum glutamate pyruvate transaminase (SGPT) =< 2.5 times institutional upper limit of normal unless there is evidence of liver metastasis, in which case the AST (SGOT)/ALT (SGPT) must be =< 5 times institutional upper limit of normal
  • Creatinine within normal institutional limits OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
  • If a woman is of child-bearing potential, a negative serum or urine pregnancy test is required; women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; participants should agree to use contraception for at least 3 months after the completion of study therapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  • Prior therapy with platinum agents (adjuvant therapy with platinum agents is allowed, if completed >= 12 months prior to relapse), or PARP inhibitors (prior iniparib, since it is no longer considered a PARP inhibitor, is allowed)
  • Patients may not be receiving any other investigational agents
  • Patients with known central nervous system (CNS) metastases requiring anticonvulsive medications, or steroids or with active symptomatology; patients on anticonvulsant medications prescribed for reasons other than CNS metastases, not on steroids and without active symptomatology are eligible; patients must be off anti-seizure medications and steroids for 3 months or more before enrollment
  • Patients with active seizure or a history of seizure; patients with CNS metastases must be stable after therapy for > 3 months and off steroid treatment prior to study enrollment
  • History of allergic reactions attributed to compounds of similar chemical or biological composition to ABT-888 (NSC 737664) or PARP Inhibitors
  • Patients with contraindications to platinum agents are excluded
  • Prior or current non-breast malignancy within 5 years except non-melanoma skin cancer or resected stage I ovarian cancer
  • Patients with any non-malignant intercurrent illness (e.g., cardiovascular, pulmonary, or central nervous system disease) which is either poorly controlled with currently available treatment or which is of such severity that the investigators deem it unwise to enter the patient on protocol
  • Pregnant women are excluded from this study; breastfeeding should be discontinued
  • Patients unable to swallow the ABT-888 tablets whole are ineligible; (the tablets cannot be crushed or broken)
  • Patients with an active severe infection; known infection with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus; HIV patients on combination antiretroviral therapy are ineligible
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
NCI-2011-01379 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
8264 ( Other Identifier: City of Hope Comprehensive Cancer Center )
8264 ( Other Identifier: CTEP )
N01CM00032 ( U.S. NIH Grant/Contract )
N01CM00038 ( U.S. NIH Grant/Contract )
N01CM00039 ( U.S. NIH Grant/Contract )
N01CM00071 ( U.S. NIH Grant/Contract )
N01CM00099 ( U.S. NIH Grant/Contract )
N01CM62201 ( U.S. NIH Grant/Contract )
N01CM62202 ( U.S. NIH Grant/Contract )
N01CM62203 ( U.S. NIH Grant/Contract )
N01CM62209 ( U.S. NIH Grant/Contract )
P30CA033572 ( U.S. NIH Grant/Contract )
Not Provided
Not Provided
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Not Provided
Principal Investigator: Jeffrey Weitzel City of Hope Comprehensive Cancer Center
National Cancer Institute (NCI)
January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP