Randomised, Multicenter Phase II Study in Patients With Metastatic Breast Cancer With Gemcitabine Plus Vinorelbine Versus Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Capecitabine

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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).