Status:

COMPLETED

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

Lead Sponsor:

Eli Lilly and Company

Conditions:

Breast Neoplasms

Eligibility:

FEMALE

18+ years

Phase:

PHASE2

Brief Summary

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

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

November 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

September 1 2007

Estimated Enrollment :

41 Patients enrolled

Trial Details

Trial ID

NCT00386087

Start Date

November 1 2006

End Date

September 1 2007

Last Update

June 6 2008

Active Locations (4)

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Page 1 of 1 (4 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.

Newark, Delaware, United States, 19713

2

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.

Indianapolis, Indiana, United States, 46202

3

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.

South Bend, Indiana, United States, 46601

4

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, 02115