Vinorelbine/Gemcitabine Versus Vinorelbine/Cisplatin in Metastatic Breast Cancer

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

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, 100 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 Vinorelbine 25 mg/m2 d1, 8;Gemcitabine 1000 mg/m2 d1, 8 q 3 weeks Arm B Vinorelbine 25 mg/m2 d1, 8;Cisplatin 25 mg/m2 d1, 2,3 q 3 weeks

Inclusion Criteria:

• Histologically confirmed metastatic breast cancer
• All patients were required to give written informed consent
• To have received a previous treatment with anthracyclines and taxanes
• Previous radiotherapy is allowed, whenever the radiated area is not the only disease location
• At least 4 weeks since the last previous antineoplastic treatment
• Patients must have recovered from all previous toxicities
• Karnofsky Performance status >= 70%
• Adequate hematological, renal, cardiac and hepatic function
• Life expectancy of at least 12 weeks
• Patients able to comply and to receive an adequate follow-up

Exclusion Criteria:

• Only bone metastases
• Active infection
• Previous treatment with one of the study drugs
• Application of other cytotoxic chemotherapy
• Insufficient renal function (creatinine clearance < 60ml/min)
• Clinically unstable brain metastasis
• Pregnancy or lactation
• Other primary malignancies (other than carcinoma-in-situ of the cervix or adequately treated basal cell cancer of the skin)
• Abnormal liver function (bilirubin > 2.0-fold upper normal limit (UNL); Alanine aminotransferase and aspartate aminotransferase >2.5-fold UNL). In patients with hepatic metastasis, a value of Alanine aminotransferase and aspartate aminotransferase of up to 5-fold UNL is permitted
• Males
• Second malignancy (except for cervix carcinoma in situ or skin carcinoma - no melanoma- with an adequate treatment). Previous malignancies are allowed if disease-free survival is superior to 5 years, except for renal carcinoma or melanoma