Conditions: Breast Cancer
Keywords: stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer stage II breast cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 74
Healthy volunteers: no

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as trastuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether docetaxel and carboplatin are more effective with or without trastuzumab in treating breast cancer.

PURPOSE: This randomized phase II trial is studying how well giving docetaxel together with carboplatin and trastuzumab before surgery works compared to docetaxel and carboplatin alone before surgery in treating women with locally advanced breast cancer.

Detailed description:

Arms:
arm 1: see intervention description arm 2: please see intervention description arm 3: please see intervention description

Interventions: intervention 1: trastuzumab intervention 2: carboplatin intervention 3: docetaxel intervention 4: trastuzumab
Intervention descriptions: intervention 1: Cycle 5-7 post-op only Day 1 4mg/kg IV Day 8, 15 2mg/kg IV Cycle 8 Cycle 8 Day 1, 8, 15 2mg/kg IV Day 22 6mg/kg IV intervention 2: Cycle 1-8 Day 1 or 2 AUC = 6 IV intervention 3: Cycle 1-8 Day 1 or 2: 75 mg/m2 IV intervention 4: Cycle 1-4 pre-op Day 1 4mg/kg IV Day 8, 15 2mg/kg IV

Cycle 5-7 post-op Day 1 4mg/kg IV Day 8, 15 2mg/kg IV

Cycle 8 Day 1, 8, 15 2mg/kg IV Day 22 6mg/kg IV

Protocol document: