Statement: Any women with stage 4 or Unresectable, locally recurrent cancer breast cancer are eligible for the primary trial.
Primary_evidence: Inclusion Criteria:   Female patients of Chinese origin with histologically or cytologically proven diagnosis of breast cancer.   Unresectable, locally recurrent breast cancer or stage IV disease.   Have at least one measurable lesion as defined by Response Evaluation Criteria In Solid Tumors (RECIST) criteria.   Performance Status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Scale   Treatment with an anthracycline-based chemotherapy regimen in the adjuvant/neoadjuvant setting with subsequent disease relapse. Exclusion Criteria:   Prior chemotherapy for unresectable, locally advanced breast cancer or metastatic disease.   Concurrent administration of any other tumor therapy, including cytotoxic chemotherapy, hormonal therapy, and immunotherapy.   Known or suspected brain metastasis or second primary malignancy that is clinically detectable at the time of consideration for study enrollment.   Active infection or other serious condition.   Pregnant or breastfeeding.