Gemcitabine and Cisplatin in Treating Patients With Metastatic Breast Cancer

OBJECTIVES: I. Assess the response rate of gemcitabine and cisplatin in the treatment of
metastatic breast cancer in patients who have failed one or two systemic regimens. II.
Determine time to progression and survival in these patients. III. Define further the
toxicity of this two-drug combination in these patients.

OUTLINE: This is a nonrandomized study. Patients receive gemcitabine IV over 30 minutes and
cisplatin IV over 1 hour on days 1, 8, and 15 every 28 days. Patients with complete response
may receive an additional 2 courses after attainment of complete response status. Treatment
continues in the absence of disease progression or unacceptable toxicities for a maximum of
8 courses. Patients are followed every 3 months for 2 years and then at 3 years after
treatment.

DISEASE CHARACTERISTICS: Histologic or cytologic confirmation of metastatic breast cancer
with two exceptions: -New or enlarging pulmonary nodules demonstrable on two chest
radiographs taken at least one month apart OR -Multiple characteristic lytic bone
metastasis or liver metastases Measurable indicator lesion Measurable metastatic disease
must be bidimensionally measurable except in the case of hepatomegaly that may be
unidimensionally measurable Patients receiving bisphosphonates must have a measurable
disease other than bone No CNS metastases unless controlled with prior surgery and/or
radiotherapy

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy:
Greater than 3 months Hematopoietic: WBC at least 3500/mm3 or absolute neutrophil count at
least 2000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 0.3
mg/dL above upper limit of normal limit (ULN) AST no greater than 3 times ULN Renal:
Creatinine no greater than 0.3 mg/dL above ULN Cardiovascular: No New York Heart
Association class III or IV heart disease Other: Physician-estimated oral caloric intake
of at least 1200 calories per day No uncontrolled infection or chronic debilitating
disease Not pregnant or nursing Women of childbearing potential must use adequate
contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Must have
previously received 1 but no more than 2 chemotherapy regimens At least 1 prior regimen
administered for metastatic disease At least 1 prior regimen containing an anthracycline
or paclitaxel At least 4 weeks since prior chemotherapy Endocrine therapy: Not specified
Radiotherapy: At least 3 weeks since prior radiotherapy No prior strontium 89 radiotherapy
Prior radiotherapy must have been to less than 25% of bone marrow Surgery: At least 4
weeks since any major surgery