A Study of Avastin (Bevacizumab) Plus Herceptin (Trastuzumab) in Patients With Primary Inflammatory HER2-Positive Breast Cancer.

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

This single arm study will assess the efficacy and safety of preoperative treatment with Avastin combined with Herceptin-based chemotherapy in patients with primary inflammatory HER2-positive breast cancer. Patients will be treated with a total of 8 cycles of pre-operative chemotherapy + Avastin + Herceptin. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.

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

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Bevacizumab; Trastuzumab

Criteria

Inclusion Criteria:

• adult females, >=18 years of age;

• inflammatory breast cancer;

• HER2-positive tumors;

• performance status 0-2.

Exclusion Criteria:

• metastases;

• previous treatment with chemotherapy, radiation therapy or hormone therapy for a breast tumor;

• clinically significant cardiovascular disease, or history of thrombotic disorders.