Bevacizumab and Docetaxel in Treating Women With Locally Advanced or Metastatic Breast Cancer

Completed · Phase 2

Conditions studied: Recurrent Breast Cancer, Stage IV Breast Cancer

In brief

This phase II trial is to see if combining bevacizumab with docetaxel works in treating women who have locally advanced or metastatic breast cancer. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells.

Key facts

Study ID

NCT00055861

Run by

National Cancer Institute (NCI)

People needed

27

Starts

2002-07-01

Last updated by the study team

2013-06-04

Who can join

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

You may qualify if…

• Histologically or cytologically confirmed breast cancer
• Local-regional recurrences or metastatic disease
• At least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
• No history or evidence of CNS disease (e.g., primary brain tumor or any brain metastases)
• Hormone receptor status:
• Not specified
• Female
• Performance status - ECOG 0-2
• Performance status - Karnofsky 60-100%
• More than 3 months
• WBC at least 3,000/mm\^3
• Absolute neutrophil count at least 1,500/mm\^3
• Platelet count at least 100,000/mm\^3
• No bleeding diathesis or coagulopathy
• Bilirubin normal
• AST/ALT no greater than 2.5 times upper limit of normal
• INR less than 1.5 (patients receiving warfarin)
• Creatinine normal
• Creatinine clearance at least 60 mL/min
• No baseline proteinuria
• Patients with proteinuria of 1+ or greater at baseline are allowed provided 24-hour urinary protein is less than 500 mg
• No symptomatic congestive heart failure
• No cardiac arrhythmia
• No uncontrolled hypertension
• No history of stroke

Where it is running

• University of Colorado Cancer Center - Anschutz Cancer Pavilion — Aurora, Colorado, United States
• Ohio State University Medical Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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