A Study of Avastin (Bevacizumab) in Patients With Inflammatory or Locally Advanced Breast Cancer

• Status: Completed
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

This single arm study will assess the efficacy and safety of sequential neoadjuvant chemotherapy and bevacizumab (Avastin), before surgery and/or radiotherapy, in participants with inflammatory or locally advanced operable breast cancer. Participants will receive 5-fluorouracil, epidoxorubicin and cyclophosphamide (FEC), followed by paclitaxel, given concomitantly with bevacizumab. 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; Cyclophosphamide; Epirubicin; Fluorouracil; Paclitaxel

Criteria

Inclusion Criteria:

• female participants, >=18 years of age;

• stage III, or inflammatory breast cancer;

• estrogen receptor/progesterone receptor (ER/PgR) positive or negative and human epidermal growth factor receptor 2 (HER-2) negative;

• normal left ventricular ejection fraction (LVEF).

Exclusion Criteria:

• previous chemotherapy/endocrine therapy;

• evidence of distant metastatic disease;

• other primary tumors in last 5 years (except for adequately treated cancer in situ of the cervix, or basal cell skin cancer);

• chronic daily treatment with >325 milligram per day (mg/day) aspirin, or >75mg/day clopidogrel.