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Lead
Medical Research Council
OBJECTIVES: I. Compare the activity and toxicity of epirubicin and cyclophosphamide with that of epirubicin and paclitaxel in patients with metastatic breast cancer.
OUTLINE: Patients are randomized to receive either epirubicin and cyclophosphamide or epirubicin and paclitaxel. Each drug combination is given every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 704 patients will be accrued for this study.
Age
Any age
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
DISEASE CHARACTERISTICS: Histologically proven carcinoma of the breast with metastases No CNS metastases Hormone receptor status: Not specified
PATIENT CHARACTERISTICS: Age: Not specified Menopausal status: Not specified Sex: Female Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 1.25 times upper limit of normal (ULN) SGOT and SGPT no greater than 2 times ULN (no greater than 5 times ULN with liver metastases) Renal: Not specified Cardiovascular: Ejection fraction within normal range No history of cardiac disease including myocardial infarction, cardiac failure and angina Other: Not pregnant No prior or concurrent malignancy that is likely to interfere with protocol treatments or comparisons
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy other than adjuvant No prior high dose adjuvant chemotherapy requiring transplantation Cumulative dose of doxorubicin no greater than 300 mg/m2 permitted Cumulative dose of epirubicin no greater than 400 mg/m2 permitted At least 6 months since prior anthracyclines Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified
Clareo Health | Epirubicin and Cyclophosphamide Compared With Epirubicin and Paclitaxel in Treating Women With Metastatic Breast Cancer
