RAD001-carboplatin combination in triple-negative metastatic breast cancer (TNMBC): A phase II trial.

1042 Background: Triple negative breast cancer cells often show genetic instability and inability to repair DNA damage rendering them sensitive to platinum agents. Rapamycin enhances platinum- induced apoptosis in breast cancer cell lines. We sought to explore the activity/toxicity of the of carboplatin with RAD001 in TNMBC. Methods: The primary objective of this study was to estimate clinical benefit rate/CBR (complete remission (CR) + partial remission (PR) + stable disease (SD) lasting >6 months) and the toxicity of this combination in women with TNMBC who have had 0-3 prior chemoregimens for MBC. 25 subjects were recruited. This design had > 80% power to test the null hypothesis that the CBR is ≤10% vs. alternative hypothesis that CBR is ≥ 30% (≥6 would need to achieve a clinical benefit). Prior Carboplatin was allowed. Women with treated brain metastasis were eligible. Originally, Carboplatin AUC 6 was administered q3 weeks with daily 5mg of RAD001 with a 3 patient run-in, then 10 mg daily. Due to ex...