Breast Cancer Clinical Trial
Official title:
Phase II Trial of Docetaxel and Carboplatin as First-Line Therapy for Metastatic 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 chemotherapy drug may kill more tumor
cells.
PURPOSE: Phase II trial to study the effectiveness of combining docetaxel and carboplatin in
treating women who have metastatic breast cancer.
OBJECTIVES: I. Determine the anti-tumor activity of docetaxel and carboplatin in women with
metastatic adenocarcinoma of the breast. II. Determine the objective response rate, time to
progression, and survival in patients treated with this regimen. III. Determine the toxic
effects of this regimen in these patients. IV. Assess the common functional polymorphisms in
genes involved in chemotherapeutic response to improve prediction of clinical outcomes and
provide insight into the potential for genotype-specific drug dosage.
OUTLINE: This is a multicenter study. Patients receive docetaxel IV over 1 hour and
carboplatin IV over 30 minutes on day 1. Treatment repeats every 3 weeks in the absence of
disease progression or unacceptable toxicity. Patients who achieve stable disease (SD),
partial response (PR), or complete response (CR) may receive 4 additional courses past SD,
PR, or CR. Patients are followed every 6 months for 2 years and then annually for 3 years.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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