Randomised, Multicenter Phase II Study in Patients With Metastatic Breast Cancer With Gemcitabine Plus Vinorelbine Versus Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Capecitabine
- Histologically confirmed metastatic breast cancer
- All patients were required to give written informed consent
- Only one prior chemotherapy for metastatic breast cancer was allowed. This clinical
trial was designed to test the efficacy of a second-line chemotherapy.
- Antracycline-pretreatment during aduvant or palliative first line therapy
- Bidimensionally measurable lesion outside a previous radiation field.
- Age >= 18 years
- Karnofsky Performance status >= 70%
- Adequate heamatological, renal, cardiac and hepatic function
- No radiation of the measurable lesion during the study was allowed.
- Only bone metastases
- Active infection
- Previous treatment with one of the study drugs
- Application of other cytotoxic chemotherapy
- Insufficent renal function (creatinine clearance < 60ml/min)
- Known DPD deficiency
- clinically unstable brain metastasis
- pregancy or lactation
- other primary malignancies (other than carcinoma-in-situ of the cervix or adequately
treated basal cell cancer of the skin).