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

Stopped early · Phase 2

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT00476827

Run by

Duke University

People needed

16

Starts

2007-05-01

Expected to finish

2011-05-01

Last updated by the study team

2013-07-17

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Active infection, non-healing wound, or history of any bleeding diathesis or coagulopathy
• Uncontrolled hypertension, congestive heart failure, peripheral vascular disease

Where it is running

• Palm Beach Cancer Center Institute — West Palm Beach, Florida, United States
• Presbyterian Health Care — Charlotte, North Carolina, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Virginia Oncology Associates — Newport News, Virginia, United States

Full record on ClinicalTrials.gov

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