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Clinical Trials

Topic   Cancer - Breast Cancer
Title   S1416: Phase II Randomized Placebo-Controlled Trial of Cisplatin with or without ABT-888 (Veliparib) in Metastatic Triple Negative Breast Cancer and/or BRCA Mutation-Associated Breast Cancer
Summary   The aim of the study is to compare any good and bad effects of using ABT-888 (Veliparib), a PARP inhibitor, with Cisplatin to using Cisplatin. Cisplatin is currently standard of care. ABT-888 (Veliparib) is investigational as it has not been approved for use by the Food and Drug Administration (FDA). This study will allow researchers to know whether ABT-888 (Veliparib) in combination with Cisplatin is better, the same, or worse than Cisplatin alone.
Description   Patients will be randomized to one of two possible treatment regimens. Patients will receive ABT-888 (Veliparib) and Cisplatin or placebo and Cisplatin. Veliparib or placebo will be taken orally twice a day in a 3 week cycle with 14 days on and 7 days off. Cisplatin will be given intravenously every 3 weeks.
IRB Number   939787
Inclusion/Notes   To be eligible to participate in this study, patients must meet several criteria including but not limited to the following: 18 years of age or older; triple negative metastatic breast cancer and/or BRCA mutation-associated breast cancer; received one or more prior cytotoxic regimen for metastatic disease; must not have received prior Cisplatin or PARP inhibitors.
Status   Open
Start Date   09/08/2016
Principal Name   Nina D’Abreo, MD
Contact Name   Johanna Lee, RN
Fax   516-663-1871
Current Trial Type   Interventional
Phone   516-663-1237
Alternate Phone   516-663-8391