Gemcitabine Plus Cisplatin Single Dose Versus Split Dose in the Treatment of Patients With Locally Advanced or Metastatic Breast Cancer After Failure of Anthracyclines and/or Taxanes

Inclusion Criteria

• •Histological or cytological diagnosis of breast carcinoma with evidence of unresectable, locally recurrent, or metastatic disease. Lesions should not be amenable to surgery or radiation of curative intent.
• •Presence of metastatic or local-regional recurrent disease, according to the American Joint Committee on Cancer
• •Uni-dimensionally measurable lesions with clearly defined margin that are clearly measurable by following methods according to computerized tomography (CT), Chest x-ray or clinical examination, according to RECIST criteria
• •Patients with unresectable, locally recurrent or metastatic breast cancer who, were pre-treated with anthracyclines with/without taxanes (paclitaxel, docetaxel)containing chemotherapy either in neoadjuvant/adjuvant or 1st line metastatic setting will be enrolled into the study. Prior chemotherapy has to be terminated 4 weeks prior. Study randomization and disease progression under this therapy has to be documented, also patients must have completely recovered from all acute chemotherapy related toxicities (with exception of alopecia).
• •Prior radiotherapy must be completed at least 30 days before study entry. Patients must have recovered from the acute toxic effects of the treatment prior to study enrollment (except for alopecia). Lesions that have been radiated cannot be included as sites of measurable disease unless clear tumor progression has been documented in these lesions since the end of radiation therapy.