Conditions: Neoplasms, Breast
Keywords: ErbB2 Overexpressing ErbB2 Positive Lapatinib Invasive Breast Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 100
Healthy volunteers: no

Brief summary:
This study will examine safety and efficacy of Lapatinib in combination with a standard neoadjuvant chemotherapy including 5FU, Epirubicin, Cyclophosphamide and Paclitaxel. Tumor tissue will be obtained at 3 timepoints (optional 4th) to evaluate tumor response to treatment.

Detailed description:

Arms:
arm 1: Trastuzumab alone for 2 weeks then in combination with FEC75 for 4 (21 Day) cycles and Paclitaxel for 4 (21 day) cycles then continued trastuzumab until time of definitive surgery arm 2: Lapatinib alone for 2 weeks then in combination with FEC75 for 4 (21 Day) cycles followed by Paclitaxel for 4 (21 day) cycles then continued lapatinib until time of definitive surgery arm 3: Trastuzumab + Lapatinib for 2 weeks then added FEC75 for 4 (21 Day) cycles followed by Paclitaxel for 4 (21 day) cycles then continued trastuzumab + lapatinib until time of definitive surgery

Interventions: intervention 1: Trastuzumab intervention 2: Paclitaxel intervention 3: FEC75 intervention 4: Lapatinib
Intervention descriptions: intervention 1: 4mg/kg IV loading dose followed by 2mg/kg IV weekly intervention 2: 80mg/m2 IV weekly for 4 (21 day) cycles intervention 3: 5FU 500mg/m2 + Epirubicin 75 mg/m2 + cyclophosphamide 500 mg/m2 IV on day 1 of 4 (21 day) cycles intervention 4: 1250 mg oral daily dose in arm 2, 750 mg oral daily dose for FEC cycles and then 1000 mg oral daily dose during the Paclitaxel cycles in arm 3

Protocol document: