Breast Cancer Clinical Trial
Official title:
CMF AND MITOXANTRONE IN ELDERLY PATIENTS WITH ADVANCED BREAST CANCER, A RANDOMIZED PHASE II STUDY
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Giving drugs in different combinations may kill more tumor
cells.
PURPOSE: Randomized phase II trial to compare the effectiveness of cyclophosphamide,
methotrexate, and fluorouracil with mitoxantrone in treating older patients with recurrent
or metastatic breast cancer.
OBJECTIVES: I. Determine the response rate and duration of response of elderly patients with
advanced breast cancer treated with first-line chemotherapy with mitigated "classical" CMF
(cyclophosphamide/methotrexate/fluorouracil) vs. mitoxantrone (DHAD). II. Define the
morbidity of CMF and DHAD in elderly patients. III. Determine quality of life in these
patients.
OUTLINE: This is a randomized study. Patients are stratified by participating institution.
The first group receives oral cyclophosphamide on days 1 through 14 and intravenous
methotrexate and fluorouracil on days 1 and 8. Courses repeat every 4 weeks for a maximum of
6 courses. The second group receives intravenous mitoxantrone every 3 weeks for a maximum of
8 courses. Concomitant therapy with hepatotoxic or nephrotoxic drugs (e.g., NSAIDs) or
corticosteroids (even as antiemetics) is not permitted in either group. Radiotherapy is
allowed provided no more than 50% of the bone marrow is irradiated and at least 1 indicator
lesion is unirradiated. Patients who complete therapy are followed every 3 months until
disease progression.
PROJECTED ACCRUAL: 60 patients will be accrued over approximately 1 year. If extreme
differences between arms exist after entry of 30 patients, accrual may be stopped early.
;
Primary Purpose: Treatment
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