This study is for patients with Triple Negative Breast Cancer, or patients that are ER/PR +, HER2- and have known BRAC1/2 mutations. PF-01367338, the investigational drug in this study, is a PARP inhibitor. PARP is an enzyme that plays a role in telling DNA to repair a damaged cell. A PARP inhibitor blocks this action so the cancerous cell has less of a chance to repair itself after receiving treatment with chemotherapy.
This study will have a safety run-in portion for the first twelve subjects. These subjects will receive the combination of Cisplatin and PF-01367338 and will be monitored for at least 6 weeks for toxicity (side effects) that may limit the dose of the combination of these drugs. There will be two dose levels of the PF-01367338, 16mg and 24mg with six subjects enrolled in each. Once the dose has been determined the study will move on to a randomized study of single treatment with cisplatin compared to combination cisplatin with PF-01367338. To be eligible for this study subjects must have completed definitive resection of primary tumor and adjuvant radiation therapy.
The Primary Objective of this study is to evaluate 2-year disease-free survival (DFS), in patients with confirmed TNBC or ER/PR + HER2-, known BRCA1/2 mutations treated with single agent cisplatin and patients treated with cisplatin in combination with PF-01367338 following preoperative chemotherapy.