Conditions: Neoplasms, Breast
Keywords: neo-adjuvant trastuzumab early breast cancer lapatinib
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 121
Healthy volunteers: no

Brief summary:
Evaluate the activity of Trastuzumab, Lapatinib, and a combination of both agents with chemotherapy in the preoperative (neoadjuvant) treatment of early breast cancer.

Detailed description:

Arms:
arm 1: Chemotherapy plus trastuzumab arm 2: Chemotherapy plus lapatinib arm 3: Chemotherapy plus trastuzumab plus lapatinib

Interventions: intervention 1: lapatinib intervention 2: trastuzumab intervention 3: paclitaxel intervention 4: fluorouracil intervention 5: epidoxorubicin intervention 6: cyclophosphamide
Intervention descriptions: intervention 1: Arm B 1250mg/d PO Arm C 750mg/d PO intervention 2: First dose 4mg/kg in 60mins, then weekly 2mg/kg in 30 mins intervention 3: 80mg/sqm 1 hour infusion for 12 weeks intervention 4: 600mg/sqm iv day 1 q21 days for four coursess intervention 5: 75mg/sqm iv day 1 q21 days for four courses intervention 6: 600mg/sqm day 1 q21 days for four courses

Protocol document: