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

Phase 2

Completed

• Conditions: Breast Neoplasms

• Registration Number: NCT00386087
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2006-10-06
• Study First Submitted QC: 2006-10-06
• Study First Posted: 2006-10-11
• Study Start: 2006-11
• Study Completion: 2007-09
• Status Verified: 2008-04
• Last Update Submitted: 2008-06-05
• Last Update Posted: 2008-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 41

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To determine the effects of enzastaurin in the treatment of patients with breast cancer by measuring its ability to reduce the size of the tumor or prevent further increases in tumor size.

Secondary Outcome Measures

Name	Time	Method
To evaluate the length of time that enzastaurin is able to effect control of the disease.
To evaluate the side effects of enzastaurin in patients with breast cancer
To determine whether changes in laboratory tests of patients treated with enzastaurin is associated with the response of their tumors to the drug.

Trial Locations

Locations (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.; 🇺🇸 Boston, Massachusetts, United States