Mitoxantrone With or Without Docetaxel in Treating Women With Metastatic Breast Cancer

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically proven metastatic breast cancer of poor prognosis, defined by any of the following characteristics:
• •* Patient aged 35 or under
• •* Liver metastases
• •* Lung metastases combined with other disease manifestations
• •* Lung metastases without other disease manifestations but with a disease free interval of no more than 18 months
• •Indication for chemotherapy documented by either:
• •* Hormone receptor negativity OR
• •* Hormone resistant disease
• •Measurable metastatic disease required
• •* Nonmeasurable disease includes:
• •* Metastases verified only histologically
• •* Tumor parameters not precisely measurable (e.g., bone marrow involvement, lymphangitic disease)
• •No CNS metastasis or bone marrow carcinomatosis
• •Hormone receptor status:
• •* Receptor status known
• •PATIENT CHARACTERISTICS:
• •Age:
• •80 and under
• •Sex:
• •Female
• •Menopausal status:
• •Not specified
• •Performance status:
• •WHO 0-2
• •Life expectancy:
• •At least 3 months
• •Hematopoietic:
• •WBC greater than 4,000/mm\^3
• •Absolute granulocyte count greater than 2,000/mm\^3
• •Platelet count greater than 100,000/mm\^3
• •Hepatic:
• •Bilirubin no greater than 1.25 times upper limit of normal (ULN)
• •Alkaline phosphatase no greater than 6 times ULN
• •SGOT and/or SGPT no greater than 3 times ULN
• •Renal:
• •Creatinine no greater than 1.15 times ULN
• •Cardiovascular:
• •No uncontrolled hypertension
• •No congestive heart failure within the past 6 months
• •No myocardial infarction within the past 6 months
• •Other:
• •Fertile patients must use effective contraception
• •No acute or chronic infection
• •No second primary tumor
• •No other serious illness
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy:
• •No concurrent biologic therapy
• •Chemotherapy:
• •No prior chemotherapy for metastatic disease
• •Greater than 1 year since prior adjuvant chemotherapy
• •No prior anthracycline or anthraquinone
• •Endocrine therapy:
• •Hormone resistant disease required of receptor positive patients
• •No concurrent endocrine therapy
• •Radiotherapy:
• •No prior mediastinal irradiation
• •Adjuvant irradiation of parasternal nodes eligible
• •No prior irradiation to more than 25% of bone marrow
• •No concurrent irradiation of sole measurable lesion
• •Surgery:
• •Not specified
• •Other:
• •No concurrent anticoagulant therapy