Efficacy Study of Gemcitabine-Paclitaxel to Treat Metastatic Breast Cancer

Phase II Study of Gemcitabine-Paclitaxel 3-Weekly Schedule as First-Line Treatment in Metastatic Breast Cancer After Anthracycline Failure

The purpose of this study is to determine the response rate to a gemcitabine-paclitaxel combination administered on a 3-weekly schedule in Chinese patients with unresectable, locally recurrent breast cancer or metastatic breast cancer.

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.