Sorafenib in Treating Patients With Metastatic Breast Cancer

Completed · Phase 2

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

In brief

This phase II trial is studying how well sorafenib works in treating patients with metastatic breast cancer. Sorafenib may stop the growth of tumor cells by blocking the enzymes necessary for their growth and by stopping blood flow to the tumor.

Key facts

Study ID

NCT00096434

Run by

National Cancer Institute (NCI)

People needed

23

Starts

2004-09-01

Last updated by the study team

2024-03-07

Who can join

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

You may qualify if…

• Histologically or cytologically confirmed breast cancer
• Clinical evidence of metastatic disease
• Measurable disease
• HER2-positive or -negative disease
• If HER2 gene amplified or strongly positive for HER2 by immunohistochemistry, patient must have had prior treatment containing trastuzumab (Herceptin®) unless contraindicated
• Previously treated with anthracycline- and/or taxane-containing regimen in the neoadjuvant, adjuvant, or metastatic setting
• Candidate for first- or second-line chemotherapy for metastatic disease
• Core block or tumor slides of the primary or metastatic tumor available
• No known brain metastases
• Hormone receptor status:
• Not specified
• Male or female
• Performance status - ECOG 0-1
• At least 3 months
• WBC ≥ 3,000/mm\^3
• Absolute neutrophil count ≥ 1,500/mm\^3
• Platelet count ≥ 100,000/mm\^3
• Hemoglobin ≥ 8.5 g/dL
• No evidence of bleeding diathesis
• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• AST ≤ 3 times ULN
• Alkaline phosphatase ≤ 3 times ULN
• PT normal
• PTT normal
• INR normal

Where it is running

• North Central Cancer Treatment Group — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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