Development of an active second-line treatment option for metastatic breast cancer patients previously pre-treated with anthracyclines and taxanes in neoadjuvant, adjuvant or palliative settings.

For each randomisation arm, 47 patients will be included. The trial was performed as a 2-stage phase II study according to the optimal design by Simon with overall response rate as the primary objective.

Study Design:

Arm A Gemcitabine 1000 mg/m2 d1, 8; Vinorelbine 25 mg/m2 d1, 8 q 3 weeks

Arm B Gemcitabine 1000 mg/m2 d1, 8; Cisplain 30 mg/m2 d1, 8 q 3 weeks

Arm C Gemcitabine 1000 mg/m2 d1, 8; Capecitabine 1650 mg/m2 oral d1-14 q 3 weeks

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).