Phase III Study of Gemcitabine Plus a Cytotoxic Agent Versus Two Cytotoxic Agents

Phase III Study of Docetaxel in Combination With Gemcitabine Versus Docetaxel in Combination With Capecitabine in Patients With Locally Advanced or Metastatic Breast Cancer

This is a phase III randomized study which compares two different regimens of chemotherapy. The purpose of the study is to determine which of the two regimens will make the tumor smaller or disappear, and for how long. In addition the disease-related symptoms will be evaluated. The safety of the drugs will be determined based upon evaluation of the side effects

Inclusion Criteria:

• Locally advanced and/or metastatic breast cancer.
• Measurable disease
• Previously treated with anthracycline

Exclusion Criteria:

• Patients with inflammatory breast disease