A Study of Pertuzumab in Combination With Herceptin and Chemotherapy in Participants With HER2-Positive Breast Cancer
Status:
Completed
Trial end date:
2016-01-01
Target enrollment:
Participant gender:
Summary
This 3 arm study will assess the tolerability, safety and efficacy of 3 neoadjuvant treatment
regimens in participants with locally advanced, inflammatory or early stage human epidermal
growth factor receptor 2 (HER2)-positive breast cancer. Before surgery, participants will be
randomized to receive either A) 6 cycles of pertuzumab plus trastuzumab (Herceptin), with
5-fluorouracil/epirubicin/cyclophosphamide (FEC) for cycles 1-3 and docetaxel for cycles 4-6,
or B) FEC for cycles 1-3 followed by pertuzumab plus trastuzumab with docetaxel for cycles
4-6, or C) 6 cycles of pertuzumab plus trastuzumab with docetaxel and carboplatin. Pertuzumab
will be administered at a loading dose of 840 mg intravenously (iv), then 420 mg iv 3-weekly,
trastuzumab at a loading dose of 8 mg/kg iv, then 6 mg/kg iv 3-weekly, docetaxel at 75 mg/m^2
iv, increased to 100 mg/m^2 iv 3-weekly, and FEC and carboplatin iv 3-weekly at standard
doses. Following surgery participants will receive trastuzumab 6 mg/kg iv 3-weekly for a
total of 1 year, as well as adequate chemo-, radio- and hormone therapy. Anticipated time on
study treatment is 4-12 months, and target sample size is 200-300.