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

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00386087
First received: October 6, 2006
Last updated: June 5, 2008
Last verified: April 2008
History of Changes
  Purpose

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


Condition Intervention Phase
Breast Neoplasms
 Drug: Enzastaurin Hydrochloride
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Oral Enzastaurin in Patients With Metastatic Breast Cancer Previously Treated With an Anthracycline and a Taxane-Containing Regimen

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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:
  • 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.

Estimated Enrollment: 41
Study Start Date: November 2006
Study Completion Date: September 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00386087

Locations
United States, Delaware
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
United States, Indiana
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
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
United States, Massachusetts
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
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern Time(UTC/GMT - 5 Hours, EST) Eli Lilly and Company
  More Information

Additional Information:
Hoosier Oncology Group  This link exits the ClinicalTrials.gov site
Lilly Clinical Trial Registry  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00386087     History of Changes
Other Study ID Numbers: 10517, H6Q-MC-S015
Study First Received: October 6, 2006
Last Updated: June 5, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:
Breast Cancer
Cancer of the Breast

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 16, 2013