OBJECTIVES: Primary * Determine the antitumor activity of irinotecan and docetaxel, in terms of response rate, in patients with refractory metastatic breast cancer. Secondary * Determine the toxicity profile of this regimen in these patients. * Determine the progression-free and overall survival of patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive docetaxel IV over 1 hour followed by irinotecan IV over 1 hour on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 2 additional courses beyond CR. Patients are followed every 2 months until disease progression and then every 6 months thereafter.
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the breast * Metastatic disease * Previously treated with chemotherapy in the adjuvant setting and/or for metastatic disease * At least one unidimensionally measurable lesion * At least 20 mm by CT scan or MRI OR at least 10 mm by spiral CT scan * Superficial clinical lesions (e.g., skin nodules or palpable lymph nodes) are allowed * Lesions on chest x-ray are allowed provided they are clearly defined and surrounded by aerated lung * The following are not considered measurable: * Bone lesions * Ascites * Leptomeningeal disease * Pleural/pericardial effusion * Inflammatory breast disease * Lymphangitis cutis/pulmonis * Cystic lesions * No known CNS metastases unless controlled by prior surgery and/or radiotherapy * Hormone receptor status: * Estrogen receptor (ER) and/or progesterone receptor (PR) status known PATIENT CHARACTERISTICS: Age * 18 and over Sex * Male or female Menopausal status * Not specified Performance status * ECOG 0-2 Life expectancy * At least 3 months Hematopoietic * Granulocyte count ≥ 1,500/mm\^3 * Hemoglobin ≥ 8.0 g/dL * Platelet count ≥ 100,000/mm\^3 Hepatic * Bilirubin ≤ upper limit of normal (ULN) * Meets 1 of the following criteria: * AST or ALT ≤ ULN AND alkaline phosphatase ≤ 5 times ULN * Alkaline phosphatase ≤ ULN AND AST or ALT ≤ 5 times ULN * AST or ALT ≤ 1.5 times ULN AND alkaline phosphatase ≤ 2.5 times ULN Renal * Creatinine ≤ 1.5 times ULN Cardiovascular * No myocardial infarction within the past 180 days * No congestive heart failure * No unstable angina * No clinically significant pericardial effusion or arrhythmias Other * No active, unresolved infection * No prior severe hypersensitivity reaction to docetaxel, irinotecan, or any drug formulated with polysorbate 80 * No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix * No grade 1 or greater sensory or motor neuropathy * No other concurrent severe condition that would preclude study participation * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * Prior trastuzumab (Herceptin®) required for HER-2-positive patients (unless contraindicated) Chemotherapy * See Disease Characteristics * More than 14 days since prior chemotherapy * No more than 2 prior chemotherapy regimens for metastatic disease * No prior irinotecan or docetaxel for metastatic disease * Docetaxel as adjuvant therapy allowed * No other concurrent chemotherapy Endocrine therapy * Prior hormonal therapy required for patients with ER- and/or PR-positive tumors (unless contraindicated) Radiotherapy * See Disease Characteristics * At least 30 days since prior radiotherapy * No concurrent radiotherapy Surgery * See Disease Characteristics * At least 3 weeks since prior major surgery and recovered Other * More than 7 days since prior parenteral antibiotic therapy * No other concurrent experimental drugs
está designado en este estudio
de ser asignado al grupo placebo