Docetaxel and Carboplatin in Treating Women With Metastatic Breast Cancer

OBJECTIVES: I. Determine the anti-tumor activity of docetaxel and carboplatin in women with
metastatic adenocarcinoma of the breast. II. Determine the objective response rate, time to
progression, and survival in patients treated with this regimen. III. Determine the toxic
effects of this regimen in these patients. IV. Assess the common functional polymorphisms in
genes involved in chemotherapeutic response to improve prediction of clinical outcomes and
provide insight into the potential for genotype-specific drug dosage.

OUTLINE: This is a multicenter study. Patients receive docetaxel IV over 1 hour and
carboplatin IV over 30 minutes on day 1. Treatment repeats every 3 weeks in the absence of
disease progression or unacceptable toxicity. Patients who achieve stable disease (SD),
partial response (PR), or complete response (CR) may receive 4 additional courses past SD,
PR, or CR. Patients are followed every 6 months for 2 years and then annually for 3 years.

DISEASE CHARACTERISTICS: Histologically proven metastatic adenocarcinoma of the breast
Measurable disease At least 20 mm in at least 1 dimension Hormone receptor status: Not
specified

PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: Not specified
Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Granulocyte
count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater
than upper limit of normal (ULN) SGOT/SGPT no greater than 2.5 times ULN Alkaline
phosphatase no greater than ULN OR SGOT/SGPT no greater than ULN Alkaline phosphatase no
greater than 4 times ULN Renal: Creatinine no greater than 1.5 times ULN Cardiovascular:
No myocardial infarction within the past 6 months No congestive heart failure No unstable
angina No clinically significant pericardial effusion or arrhythmia Other: No other
invasive malignancy within the past 5 years except curatively treated basal cell or
squamous cell skin cancer or carcinoma in situ of the cervix No active unresolved
infection No prior hypersensitivity reaction to docetaxel No grade 2 or greater sensory or
motor neuropathy Not pregnant or nursing Negative pregnancy test Fertile patients must use
effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent prophylactic filgrastim (G-CSF)
during the first course of study therapy Chemotherapy: No prior chemotherapy for
metastatic disease Prior adjuvant chemotherapy allowed More than 1 year since prior
paclitaxel, docetaxel, cisplatin, or carboplatin No other concurrent chemotherapy
Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy
to breast, chest wall, or axilla No prior radiotherapy to greater than 30% of bone marrow
No concurrent radiotherapy Surgery: At least 4 weeks since prior major surgery and
recovered Other: More than 7 days since prior IV antibiotics No concurrent experimental
drugs