Enzastaurin in Combination of Capecitabine to Treat Breast Cancer

A Double-Blind, Randomized, Phase 2 Trial of Capecitabine Plus Enzastaurin Versus Capecitabine Plus Placebo in Patients With Metastatic or Recurrent Breast Cancer Previously Treated With an Anthracycline and a Taxane

The purpose of this study is to determine whether the combination of enzastaurin and capecitabine is more effective than the combination of placebo and capecitabine in treating participants with breast cancer who were previously treated with an anthracycline and a taxane.

Inclusion Criteria:

• Have been diagnosed with metastatic or recurrent breast cancer.
• Have been previously treated with both an anthracycline and a taxane.
• Have not received more than two prior chemotherapy treatment programs.
• Have stopped any antitumoral hormonal treatment before you enroll in this study.
• Have a negative pregnancy blood test if menstruating or capable of becoming pregnant. You must use an approved birth control method during the study and for 3 months after stopping study treatment.

Exclusion Criteria:

• Cannot follow the study procedures (for example, you cannot swallow tablets).
• Are receiving another treatment for your cancer.
• Have received another experimental drug in the last 4 weeks.
• Have had serious heart disease within last 6 months.
• Are pregnant or breast-feeding.