Breast Cancer Clinical Trial
Official title:
Study Of The Survival Without Degradation To The Quality Of Life During Chemotherapy For Metastatic Breast Cancer In Women
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 combination chemotherapy in treating
older women who have metastatic breast cancer.
OBJECTIVES:
- Determine the survival without degradation of quality of life in elderly women with
metastatic breast cancer treated with leucovorin calcium, fluorouracil, and
mitoxantrone.
- Determine the efficacy of this regimen, in terms of response and survival without
progression, in these patients.
- Determine the tolerance of these patients to this regimen.
OUTLINE: This is a multicenter study.
Patients receive mitoxantrone IV and leucovorin calcium IV over 2 hours on day 1. Patients
then receive fluorouracil IV over 46 hours on days 1-2. Treatment repeats every 21 days for
a maximum of 8 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, after 3 courses, and at treatment completion.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 39 patients will be accrued for this study.
;
Primary Purpose: Treatment
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