Gemcitabine + Carboplatin in Breast Cancer

Inclusion criteria

• Histologically confirmed metastatic breast cancer
• All patients were required to give written informed consent.
• Prior treatment with chemotherapy, hormonal therapy, immunotherapy or local radiotherapy was allowed (except gemcitabine or platinum agents).
• Patients were required to have at least one bidimensionally measurable lesion outside a previous radiation port.
• Age ≥ 18 years
• Karnofsky Performance status ≥ 70 %
• Minimal life expectancy of 12 weeks
• Adequate haematological, renal, cardiac and hepatic function:

• Leukocyte count ≥ 3.0 x 109/l
• Absolute neutrophil count ≥ 2.0 x 109/l
• Platelet count ≥ 100 x 109/l
• Haemoglobin ≥ 8 g/dl
• Total serum bilirubin ≤ 1.25 x upper limit of normal (ULN) In presence of liver metastasis ≤ 3 x ULN
• Transaminase (ALT,AST) level ≤ 3 x ULN In presence of liver metastasis ≤ 5 x ULN
• Alkaline phosphatase level ≤ 2.5 x ULN
• Creatinine clearance was required to exceed 60 ml/min.

Exclusion criteria

• Prior treatment with gemcitabine or platinum agents
• Inadequate creatinine clearance (< 60 ml/min)
• Only bone metastases
• Symptomatic brain metastases
• Women who are pregnant, lactating or refuse effective contraception
• Secondary malignancy
• History of another primary malignant disease other than in situ carcinoma of the uterine cervix or adequately treated basal cell skin cancer
• Active infection
• Any other concomitant severe clinical condition making implementation of the protocol including pre-hydration difficult.