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: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Docetaxel; Pertuzumab; Trastuzumab

Criteria

Inclusion Criteria:

• female patients, >=18 years of age;

• locally advanced, inflammatory or early stage invasive breast cancer;

• HER2 positive (HER2+++ by IHC or FISH/CISH+).

Exclusion Criteria:

• metastatic disease (Stage IV) or bilateral breast cancer;

• previous anticancer therapy or radiotherapy for any malignancy;

• other malignancy, other than cancer in situ of the cervix, or basal cell cancer;

• insulin-dependent diabetes;

• clinically relevant cardiovascular disease.