A Study of Pertuzumab in Combination With Herceptin in Patients With HER2 Positive Breast Cancer.
Status:
Completed
Trial end date:
2014-09-22
Target enrollment:
Participant gender:
Summary
This 4 arm study will evaluate the efficacy and safety of 4 neoadjuvant treatment regimens in
female patients with locally advanced, inflammatory or early stage HER2 positive breast
cancer. Before surgery, patients will be randomized to one of 4 treatment arms, to receive 4
cycles of a)Herceptin + docetaxel b)Herceptin + docetaxel + pertuzumab c)Herceptin +
pertuzumab or 4)pertuzumab + docetaxel. Pertuzumab will be administered at a loading dose of
840mg iv, then 420mg iv 3-weekly, Herceptin at a loading dose of 8mg/kg iv then 6mg/kg
3-weekly, and docetaxel at a dose of 75mg/m2 escalating to 100mg/m2 3-weekly. During the
entire pre- and post-surgery period all patients will receive adequate chemotherapy as per
standard of care, as well as any surgery and/or radiotherapy as required. The anticipated
time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.