Conditions: Breast Cancer
Keywords: metastatic breast cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 25
Healthy volunteers: no

Brief summary:
This study investigates the effectiveness of combination of carboplatin and investigational agent RAD001 in triple-negative breast cancer.

Detailed description:
The primary objective of this study was to determine clinical benefit rate (CBR) i.e.complete remission (CR) + partial remission (PR) + stable disease (SD) lasting ≥ 6 months, and the toxicity of RAD001 /carboplatin in women with metastatic triple-negative breast cancer. Treatment consisted of intravenous carboplatin at area under the plasma concentration-time curve (AUC) 6, later decreased to AUC 5, and subsequently to AUC 4 every 3 weeks with daily 5mg RAD001.

Arms:
arm 1: Carboplatin (starting dose was initially AUC 6, later decreased to AUC 5, then AUC 4) every 3 weeks as IV infusion and RAD001 as 5 mg pill each day until disease progression or unacceptable toxicity.

Interventions: intervention 1: RAD001 intervention 2: Carboplatin
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: