Enzastaurin in Combination of Capecitabine to Treat Breast Cancer

Lilly

Status and phase: Terminated; Phase 2

Conditions: Breast Cancer

Treatments: Drug: capecitabine; Drug: placebo; Drug: enzastaurin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00437294

10536

H6Q-MC-S035 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 86 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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86 participants in 2 patient groups, including a placebo group

Capecitabine + Enzastaurin

Experimental group

Treatment:

Drug: capecitabine

Drug: enzastaurin

Capecitabine + Placebo

Placebo Comparator group

Treatment:

Drug: capecitabine

Drug: placebo