Patients receive carboplatin IV over 1 hour on day 1 and veliparib PO BID on days 1-7 or 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients may undergo fluorothymidine PET scan and peripheral blood cell and tumor tissue collection periodically for correlative studies.

BRCA1 Gene Mutation

BRCA2 Gene Mutation

Estrogen Receptor Negative

Estrogen Receptor Positive

HER2/Neu Negative

Progesterone Receptor Negative

Progesterone Receptor Positive

Recurrent Breast Carcinoma

Stage IIIB Breast Cancer AJCC v7

Stage IIIC Breast Cancer AJCC v7

Stage IV Breast Cancer AJCC v6 and v7

Triple-Negative Breast Carcinoma

Carboplatin

Fluorothymidine F-18

Laboratory Biomarker Analysis

Pharmacological Study

Positron Emission Tomography

Veliparib

Montefiore Medical Center-Einstein Campus

Montefiore Medical Center - Moses Campus

Ohio State University Comprehensive Cancer Center

Veliparib and Carboplatin in Treating Patients With HER2-Negative Metastatic Breast Cancer

A Phase 1 Dose-Escalation Study of ABT-888 (Veliparib) in Combination With Carboplatin in HER2 Negative Metastatic Breast Cancer

Number and severity of toxicity incidents will be tabulated. Non-hematologic toxicities will be evaluated via the ordinal Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 standard toxicity grading. Hematologic toxicity measures of thrombocytopenia, neutropenia and leukopenia will be assessed using continuous variables as the outcome measures (primarily nadir and percent change from baseline values) as well as categorization via CTCAE standard toxicity grading. Frequency distributions and other descriptive measures will form the basis of the analysis of these variables.

Responses will be summarized by simple descriptive summary statistics delineating complete and partial responses as well as stable and progressive disease. Response and progression will be evaluated in this study using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors guideline (version 1.1).

Analysis will be descriptive and exploratory in nature. Potential relationships and differences will be explored using graphical analyses and quantitative summaries of this marker.

National Cancer Institute (NCI)

HRD positive tumors; irrespective of response; - a fourth course of AC followed by Peripheral Blood Progenitor Cell (PBPC) harvest and tandem intermediate-dose alkylating therapy (miniCTC, carboplatin 800 mg/m2, thiotepa 250 mg/m2, and cyclophosphamide 3000 mg/m2) with PBPC-reinfusion.

HRD tumors; any response to 3x ddAC; 3 courses of CP

non-HRD tumors; unfavourable response to 3x ddAC; 3 courses of Carboplatin and Paclitaxel

non-HRD tumors; favourable response to 3x ddAC; 3 more courses of ddAC

non-HRD tumors; favourable response to 3x ddAC; 3 courses of Carboplatin and Paclitaxel

Breast Cancer

Carboplatin AUC = 6, Q 3 weeks, 3 courses Paclitaxel 80 mg/m2, weekly, 9 administrations

Carboplatin and Paclitaxel

Two-weekly administrations of 600 mg/m2 cyclophosphamide and 60 mg/m2 doxorubicin PEG-filgrastim (Neulasta(r)) will be administered on the day following chemotherapy.

Doxorubicin, cyclophosphamide

One course of of 600 mg/m2 cyclophosphamide and 60 mg/m2 doxorubicin. PEG-filgrastim (Neulasta(r)) will be administered on the day following chemotherapy.
This course is followed by Peripheral Blood Progenitor Cell (PBPC) harvest and tandem intermediate-dose alkylating therapy (miniCTC, carboplatin 800 mg/m2, thiotepa 250 mg/m2, and cyclophosphamide 3000 mg/m2) with PBPC-reinfusion.

fanconi anemia/progesterone

Veliparib and Carboplatin in Treating Patients With HER2-Negative Metastatic Breast Cancer

Neo Adjuvant Chemotherapy in Triple Negative Breast Cancer

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