A Phase II Safety and Tolerability Study of Bevacizumab When Added to Single-agent Chemotherapy to Treat Patient With Breast Cancer Metastatic to Brain

• Status: Terminated
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

Our hypothesis is that this study design, in which bevacizumab is added to one of six single agent chemotherapies with proven activity in metastatic breast cancer, will result in regression or stabilization of this disease in a safe and tolerable manner.

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

Details

• Lead Sponsor: Duke University
• Collaborator: Genentech, Inc.
• Treatments: Albumin-Bound Paclitaxel; Bevacizumab; Capecitabine; Docetaxel; Gemcitabine; Irinotecan; Paclitaxel; Vinblastine; Vinorelbine

Criteria

Inclusion Criteria:

• Female, 18+, with evaluable metastatic breast cancer and stable brain metastases

• Must have received definitive radiotherapy

• No evidence, or history of, central nervous system hemorrhage

• Adequate organ and hematological function

Exclusion Criteria:

• Active infection, non-healing wound, or history of any bleeding diathesis or coagulopathy

• Uncontrolled hypertension, congestive heart failure, peripheral vascular disease