Statement: Patients must have a one bi-dimensional, measurable indicator lesion to be included in the primary trial
Primary_evidence: Inclusion Criteria:   Female patients with histological or cytological proven diagnosis of breast cancer   Stage IV disease   Performance Status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Scale   Patients had to have previously received anthracycline based regimens as a adjuvant therapy or neo-adjuvant chemotherapy and then progressed and developed metastatic disease   Adequate organ function Exclusion Criteria:   Prior chemotherapy for metastatic disease   Previous radiation therapy is allowed but must not have included whole pelvis radiation   Known or suspected brain metastasis. Serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator   Concurrent administration of any other tumor therapy, including cytotoxic chemotherapy, hormonal therapy and immunotherapy (including trastuzumab (Herceptin))   Peripheral neuropathy of Common Toxicity Criteria (CTC) Grade greater than 1. History of significant neurological or mental disorder, including seizures or dementia