Recurrent Breast Carcinoma Clinical Trial
Official title:
A Phase 1 Dose-Escalation Study of ABT-888 (Veliparib) in Combination With Carboplatin in HER2 Negative Metastatic Breast Cancer
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 (HER2)-negative breast cancer that has spread to other parts of the body. Carboplatin kills cancer cells by damaging the deoxyribonucleic acid (DNA) that lets the cancer cell survive and reproduce. The body has proteins that try to repair the damaged DNA. Veliparib may prevent these proteins from repairing the DNA so that carboplatin may be able to kill more tumor cells. Giving veliparib with carboplatin may kill more tumor cells than carboplatin alone.
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 estrogen
receptor (ER)/progesterone receptor(PR) negative or ER and/or PR positive with defects in
Fanconi Anemia (FA) pathway repair genes.
II. To determine the safety and tolerability of combining veliparib on a 14-day and 21-day
schedule with carboplatin in this patient population.
III. To determine the preliminary efficacy of this combination in this patient population.
SECONDARY OBJECTIVES:
I. To determine the pharmacodynamic endpoints of poly(ADP-ribose) polymerase (PARP)
inhibition in the tumor by using, A) 3'-[F-18]fluoro-3'-deoxythymidine positron emission
tomography (FLT-PET) of the target lesions, B) circulating tumor cells to detect the
induction of the histone variant gamma H2AX, and C) peripheral blood mononuclear cells to
assess poly ADP-Ribose (PAR) levels.
II. To determine biomarkers in the primary tumor that may predict antitumor responses to PARP
inhibition such as breast cancer 1/2, early onset (BRCA)1/2 protein, Fanconi anemia,
complementation group D2 (FANCD2) nuclear foci formation and expression of micro-ribonucleic
acid (RNA) 155 (miR 155).
OUTLINE: This is a dose-escalation study of veliparib.
Patients receive carboplatin intravenously (IV) over 1 hour on day 1 and veliparib orally
(PO) twice daily (BID) on days 1-7 or 1-14. Courses repeat every 21 days in the absence of
disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 12 weeks.
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