Breast Cancer Clinical Trial
Official title:
Phase II Study of Gemcitabine (GEMZAR) and Cisplatin (CDDP) in Advanced Breast Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of gemcitabine and cisplatin in treating
patients with metastatic breast cancer that has not responded to systemic therapy.
OBJECTIVES: I. Assess the response rate of gemcitabine and cisplatin in the treatment of
metastatic breast cancer in patients who have failed one or two systemic regimens. II.
Determine time to progression and survival in these patients. III. Define further the
toxicity of this two-drug combination in these patients.
OUTLINE: This is a nonrandomized study. Patients receive gemcitabine IV over 30 minutes and
cisplatin IV over 1 hour on days 1, 8, and 15 every 28 days. Patients with complete response
may receive an additional 2 courses after attainment of complete response status. Treatment
continues in the absence of disease progression or unacceptable toxicities for a maximum of
8 courses. Patients are followed every 3 months for 2 years and then at 3 years after
treatment.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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