Carboplatin and Gemcitabine in Treating Patients With Locally Advanced or Metastatic Breast Cancer

DISEASE CHARACTERISTICS:

• Histologically confirmed breast cancer

  • Locally advanced or metastatic disease

• Recurrent or refractory disease

  • Histological or cytological confirmation required for recurrence in a solitary site
  • Must have received prior anthracycline and taxane as neoadjuvant, adjuvant, or metastatic therapy

• Measurable disease*

  • At least 1 measurable site of disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan

    • Palpable disease allowed NOTE: *Lesions that have been irradiated in the advanced setting cannot be included as sites of measurable disease

• No nonmeasurable disease only, including the following:

  • Bone lesions
  • Leptomeningeal disease
  • Ascites
  • Pleural or pericardial effusion
  • Inflammatory breast disease
  • Lymphangitic pulmonary disease
  • Abdominal masses that are not confirmed and followed by imaging techniques
  • Cystic lesions
• No HER2-positive disease, defined as 3+ by IHC OR positive by FISH or chromogenic in situ hybridization
• Hormone receptor status not specified

PATIENT CHARACTERISTICS:

• Male or female
• Menopausal status not specified
• ECOG performance status 0-1
• Estimated life expectancy ≥ 12 weeks
• Not pregnant or nursing
• Fertile patients must use effective contraception during and for 3 months after completion of study therapy
• ANC ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 9 g/dL
• ALT or AST < 2.5 times upper limit of normal (ULN)
• Bilirubin normal
• Alkaline phosphatase ≤ 2.5 times ULN
• Creatinine ≤ 1.25 times ULN OR creatinine clearance > 40 mL/min
• Calcium ≤ 1.2 times ULN
• No concurrent serious medical or psychiatric illness, including any serious active infection incompatible with the study
• No other primary malignancy except carcinoma in situ of the cervix, adequately treated nonmelanomatous skin cancer, or any other malignancy previously treated ≥ 5 years ago with no evidence of recurrence
• No peripheral neuropathy ≥ grade 2

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• Recovered from prior chemotherapy

• Prior hormonal therapy or immunotherapy allowed

  • Antitumoral hormonal therapy must be discontinued prior to study entry
• More than 4 weeks since prior radiotherapy and recovered
• No prior radiotherapy to the whole pelvis or to ≥ 25% of the bone marrow
• No prior gemcitabine hydrochloride, cisplatin, or carboplatin
• No other cytotoxic chemotherapy for 21 days before and for 14 days after completion of study therapy
• More than 30 days since prior treatment with a drug (not including study drug) that has not received regulatory approval for any indication at the time of study entry
• Bisphosphonate therapy may not be initiated or discontinued within 4 weeks of study entry

• No more than 1 prior course of chemotherapy for metastatic disease

  • Prior chemotherapy in the adjuvant setting allowed

• Concurrent palliative radiotherapy to existing painful lesions (soft tissue or bone) allowed

  • New bone pain requiring radiotherapy > 4 weeks after first study treatment considered disease progression
  • New pain in a soft tissue lesion without other objective changes may be irradiated provided ≥ 1 other site of nonirradiated measurable disease exists
• No other concurrent anticancer treatment
• No concurrent tamoxifen citrate, aromatase inhibitors, or progestagens