Veliparib With or Without Carboplatin in Treating Patients With Stage III or IV Breast Cancer
NCT ID: NCT01149083
Last Updated: 2025-08-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
77 participants
INTERVENTIONAL
2010-06-30
2024-09-30
Brief Summary
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Detailed Description
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I. To evaluate the efficacy of single agent veliparib (ABT-888) (NSC 737664) in breast cancer (BRCA) carriers with metastatic breast cancer based on response rate (Response Evaluation Criteria In Solid Tumors \[RECIST\] criteria).
SECONDARY OBJECTIVES:
I. To conduct subset analysis on BRCA1 versus (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: This is a dose-escalation study of veliparib. Patients are assigned to 1 of 2 phases.
SAFETY LEAD-IN PHASE: Patients receive veliparib orally (PO) twice daily (BID) on days 1-21 of each cycle and carboplatin intravenously (IV) over 30 minutes on day 1 of each cycle. Cycles repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo computed tomography (CT) or magnetic resonance imaging (MRI) and may optionally undergo biopsies throughout the study. Patients undergo blood sample collection during screening and on study.
PHASE II: Patients receive veliparib PO BID on days 1-21 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Upon progression, patients are taken off treatment for 1 week and may then continue to recieve veliparib along with carboplatin IV over 30 minutes on day 1 of each cycle. Cycles repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI and may optionally undergo biopsies throughout the study. Patients undergo blood sample collection during screening and on study.
\* As of the November 9, 2023 amendment, the pharmaceutical collaborator has discontinued the ABT-888 development program with the National Cancer Institute Cancer Therapy Evaluation Program (CTEP). Clinical supply will no longer be available after December 31, 2024. Patients will discontinue treatment by December 31, 2024, or earlier.
After completion of study treatment, patients are followed up every 6 months.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Phase II (veliparib, carboplatin)
Patients receive veliparib PO BID on days 1-21 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Upon progression, patients are taken off treatment for 1 week and may then continue to recieve veliparib along with carboplatin IV over 30 minutes on day 1 of each cycle. Cycles repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI and may optionally undergo biopsies throughout the study. Patients undergo blood sample collection during screening and on study.
Biopsy
Undergo biopsy
Biospecimen Collection
Undergo blood sample collection
Carboplatin
Given IV
Computed Tomography
Undergo CT
Magnetic Resonance Imaging
Undergo MRI
Veliparib
Given PO
Safety Lead-In Phase (veliparib, carboplatin)
Patients receive veliparib PO BID twice daily on days 1-21 of each cycle and carboplatin IV over 30 minutes on day 1 of each cycle. Cycles repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI and may optionally undergo biopsies throughout the study. Patients undergo blood sample collection during screening and on study.
Biopsy
Undergo biopsy
Biospecimen Collection
Undergo blood sample collection
Carboplatin
Given IV
Computed Tomography
Undergo CT
Magnetic Resonance Imaging
Undergo MRI
Veliparib
Given PO
Interventions
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Biopsy
Undergo biopsy
Biospecimen Collection
Undergo blood sample collection
Carboplatin
Given IV
Computed Tomography
Undergo CT
Magnetic Resonance Imaging
Undergo MRI
Veliparib
Given PO
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients must have a known deleterious BRCA mutation confirmed by report from a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory (generally Myriad Genetics Laboratory). It is expected that BRCA testing will be covered as medically necessary care by the patient's insurance carrier
* 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
* Female, age \>= 18 years. Because no dosing or adverse event data are currently available on the use of ABT-888 in patients \< 18 years of age, children are excluded from this study
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Life expectancy of greater than four months
* Absolute neutrophil count (ANC) \>= 1,500/mcL
* Platelets \>= 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; (The effects of ABT-888 \[NSC 737664\] on the developing human fetus are unknown; for this reason and because PARP Inhibitor agents are known to be teratogenic, 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
* 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 because ABT-888 (NSC 737664) has the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ABT-888 (NSC 737664), 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-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with ABT-888 (NSC 737664); in addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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Joanne Mortimer
Role: PRINCIPAL_INVESTIGATOR
City of Hope Comprehensive Cancer Center
Locations
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City of Hope Comprehensive Cancer Center
Duarte, California, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States
UCHealth University of Colorado Hospital
Aurora, Colorado, United States
Mayo Clinic in Florida
Jacksonville, Florida, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Siteman Cancer Center at Washington University
St Louis, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
NYP/Weill Cornell Medical Center
New York, New York, United States
Montefiore Medical Center-Einstein Campus
The Bronx, New York, United States
Montefiore Medical Center - Moses Campus
The Bronx, New York, United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, United States
UPMC-Magee Womens Hospital
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States
M D Anderson Cancer Center
Houston, Texas, United States
University Health Network-Princess Margaret Hospital
Toronto, Ontario, Canada
Countries
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References
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Egger SJ, Chan MMK, Luo Q, Wilcken N. Platinum-containing regimens for triple-negative metastatic breast cancer. Cochrane Database Syst Rev. 2020 Oct 21;10(10):CD013750. doi: 10.1002/14651858.CD013750.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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NCI-2011-01379
Identifier Type: REGISTRY
Identifier Source: secondary_id
PHII-96
Identifier Type: -
Identifier Source: secondary_id
CHNMC-PHII-96
Identifier Type: -
Identifier Source: secondary_id
CDR0000674384
Identifier Type: -
Identifier Source: secondary_id
8264
Identifier Type: OTHER
Identifier Source: secondary_id
8264
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2011-01379
Identifier Type: -
Identifier Source: org_study_id
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