Enzastaurin For Breast Cancer Patients Who Previously Received an Anthracycline and a Taxane Chemotherapy

Lilly

Status and phase: Completed; Phase 2

Conditions: Breast Neoplasms

Treatments: Drug: Enzastaurin Hydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00386087

10517

H6Q-MC-S015

Details and patient eligibility

About

The purpose of this study is to determine the effectiveness of enzastaurin in the treatment of patients with metastatic breast cancer.

Enrollment: 41 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of metastatic breast cancer or recurrent breast cancer where surgery can not be done for curative intent
• Have received prior therapy with an anthracycline (class of drugs) and a taxane (class of drugs).
• Tumors must not be positive for HER2, but if positive, the treatment plan should not include further treatment with the drug Herceptin.
• Disease that can be definitely measured on Cat Scans or other radiological tests.
• May have received high dose chemotherapy for autologous stem cell support greater than or equal to 6 months of starting this study.

Exclusion criteria

• More than 2 chemotherapy regimens for metastatic or locally recurrent disease.
• Have brain cancer from breast cancer
• Pregnant or breastfeeding
• Have an inability to swallow tablets
• Within 6 months have had a serious heart condition

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)