Summary
This randomized phase II trial studies how well cisplatin works with or without veliparib in treating patients with triple-negative breast cancer and/or BRCA mutation-associated breast cancer that has come back (recurrent) or has or has not spread to the brain (brain metastases). Drugs used in chemotherapy, such as cisplatin, 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. PARPs are proteins that help repair DNA mutations. PARP inhibitors, such as veliparib, can keep PARP from working, so tumor cells can't repair themselves, and they may stop growing. It is not yet known if cisplatin is more effective with or without veliparib in treating patients with triple-negative and/or BRCA mutation-associated breast cancer.
Description
PRIMARY OBJECTIVES:
I. To compare the efficacy of cisplatin with or without ABT-888 (veliparib) on progression-free survival (PFS) in each of the following groups:
Ia. Patients with germline BRCA (gBRCA) mutation-associated breast cancer. Ib. Patients with germline BRCA wild-type breast cancer who have evidence of BRCAness phenotype.
Ic. Patients with germline BRCA wild-type breast cancer who do not have evidence of BRCAness phenotype.
II. To compare the efficacy of cisplatin with or without ABT-888 on PFS in patients with triple negative and/or gBRCA mutation-associated breast cancer and brain metastases. (Brain Metastases Cohort)
SECONDARY OBJECTIVES:
I. For patients with gBRCA mutation associated breast cancer (group "i" above) or triple-negative breast cancer (TNBC) with (group "ii") or without (group "iii") BRCAness phenotype, to compare the efficacy of cisplatin with or without ABT-888 on overall survival (OS), response rate, and clinical benefit rate.
II. To compare the differential benefit of ABT-888 across the three groups using both PFS and OS as outcomes.
III. For patients in the brain metastases cohort, to compare the efficacy of cisplatin with or without ABT-888 on OS.
IV. For patients in the brain metastases cohort, to compare the efficacy of cisplatin with or without ABT-888 on intracranial and extracranial response rates (intracranial by Response Assessment Neuro-Oncology Criteria [RANO] and extracranial by Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST 1.1]).
V. To compare toxicities of ABT-888 to placebo in each of the four groups separately.
Principal Investigator
Study Coordinator
Research Contact
Megan Ware - megan.ware@vandaliahealth.org