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
- 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.
- Cannot follow the study procedures (for example, you can not 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.
Type of Study:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Progression free survival
Outcome Time Frame:
baseline to measured progressive disease
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Eli Lilly and Company
United States: Food and Drug Administration
- Breast Cancer
- Breast Neoplasms