Status:
ACTIVE_NOT_RECRUITING
Veliparib and Carboplatin in Treating Patients With HER2-Negative Metastatic Breast Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Recurrent Breast Carcinoma
Stage IIIB Breast Cancer AJCC v7
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This phase I trial studies the side effects and best dose of veliparib when given together with carboplatin and to see how well they work in treating patients with human epidermal growth factor 2 (HER...
Detailed Description
PRIMARY OBJECTIVES: I. To determine the recommended phase II dose of veliparib along with carboplatin on a 14-day and 21-day schedule in patients with Her2 negative metastatic breast cancer that are ...
Eligibility Criteria
Inclusion
- Patients must have histologically or cytologically proven metastatic or locally advanced inoperable breast cancer that fulfills one of the following two criteria:
- Triple-negative breast cancer
- ER and/or PR positive, HER2 negative if their tumors have been shown to be deficient for the FA pathway, based on FA triple stain immunofluorescence (FATSI) screening
- HER negative with a known germline BRCA1/2 mutation
- Patients with ER- and/or PR-positive breast cancer will be consented to have their existing, or to be obtained, paraffin-embedded tumor tissue screened for FA deficiency
- No more than 3 prior chemotherapy regimens for metastatic disease will be allowed; any number of prior hormone therapies will be allowed; however, at least 4 weeks should have elapsed since prior chemotherapy (6 weeks for mitomycin C and nitrosoureas and 2 weeks for hormone therapy) or radiation therapy (2 weeks for limited field palliative radiation to the bone)
- Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 60%)
- Patients with treated brain metastases and life expectancy of greater than 3 months
- Patients with known Gilbert syndrome with abnormal unconjugated bilirubin will be eligible
- Absolute neutrophil count \>= 1,500/mcL
- Platelets \>= 100,000/mcL
- Total bilirubin within normal institutional limits
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic acid transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 X 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
- No prior therapy with veliparib for metastatic disease will be allowed
- 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; 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
- Patients must be able to swallow pills
Exclusion
- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
- Patients may not be receiving any other investigational agents
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to veliparib or other agents used in study
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with veliparib
- Known human immunodeficiency virus (HIV)-infected patients on protease inhibitors are ineligible; HIV-infected patients with adequate cluster of differentiation (CD)4 counts (\> 500) and not on protease inhibitors are eligible
- Patients with active seizure or a history of seizures are not eligible
- Patients with uncontrolled central nervous system (CNS) metastasis are not eligible; patients with CNS metastases must be stable after therapy for \> 3 months and off steroid treatment prior to study enrollment
Key Trial Info
Start Date :
November 22 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 19 2026
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT01251874
Start Date
November 22 2010
End Date
November 19 2026
Last Update
November 21 2025
Active Locations (3)
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1
Montefiore Medical Center-Einstein Campus
The Bronx, New York, United States, 10461
2
Montefiore Medical Center - Moses Campus
The Bronx, New York, United States, 10467
3
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210