Conditions: Metastatic Breast Cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 136
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine the ORR associated with Doxil in combination with carboplatin in HER2- (negative) MBC (and with Herceptin in HER2+ MBC).

Detailed description:

Arms:
arm 1: Patients will receive IV Doxil 30 mg/m2 and carboplatin AUC=5 on Day 1 of each cycle. A cycle consists of 28 days. In addition, HER2+ (IHC3+ and FISH+) patients only will receive a one-time loading dose of Herceptin 8 mg/kg IV on Day 1 of Cycle 1 and 4 mg/kg on Day 1 and Day 15 of every cycle thereafter.

Interventions: intervention 1: Pegylated liposomal doxorubicin intervention 2: Carboplatin intervention 3: trastuzumab
Intervention descriptions: intervention 1: 30 mg/m2 IV on Day 1 of each 28 day cycle intervention 2: AUC=5 on Day 1 of each 28 day cycle intervention 3: 4 mg/kg on Days 1 and 15 of each cycle(loading dose of 8 mg/kg on Day 1 of Cycle 1 only)

Protocol document: