Bevacizumab Plus Vinorelbine in Treating Patients With Stage IV Breast Cancer

Completed · Phase 2

Conditions studied: Male Breast Cancer, Recurrent Breast Cancer, Stage IV Breast Cancer

In brief

Phase II trial to study the effectiveness of bevacizumab combined with vinorelbine in treating patients who have stage IV breast cancer. Monoclonal antibodies such as bevacizumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining monoclonal antibody with chemotherapy may kill more cancer cells

Key facts

Study ID

NCT00017394

Run by

National Cancer Institute (NCI)

People needed

56

Starts

2001-03-01

Last updated by the study team

2013-01-17

Who can join

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

You may qualify if…

• Histologically or cytologically confirmed stage IV breast cancer
• Patients without pathologic or cytologic confirmation of metastatic disease must have unequivocal evidence of metastasis by physical exam or radiologic study
• Must meet 1 of the following criteria:
• Received 1 or 2 prior conventional chemotherapy regimens for metastatic disease
• Relapsed within 1 year after adjuvant chemotherapy and no prior chemotherapy for metastatic disease
• At least 1 unidimensionally measurable lesion, meeting 1 of the following criteria:
• At least 20 mm by conventional techniques
• At least 10 mm by spiral CT scan
• No CNS metastases by CT scan or MRI within the past 6 weeks
• No prior or concurrent primary CNS tumor on physical exam
• Disease progression after bone marrow or peripheral blood stem cell transplantation allowed
• HER2-positive tumors allowed if previously treated with trastuzumab (Herceptin)
• Hormone receptor status:
• Not specified
• Male or female
• Performance status - ECOG 0-2
• Performance status - Karnofsky 60-100%
• More than 3 months
• Absolute neutrophil count at least 1,500/mm\^3
• Hemoglobin at least 9 g/dL
• Platelet count at least 100,000/mm\^3
• No prior bleeding diathesis or coagulopathy
• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• AST/ALT no greater than 2.5 times ULN
• INR no greater than 1.5

Where it is running

• Dana-Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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