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

June 5, 2008 updated by: Eli Lilly and Company

A Phase II Study of Oral Enzastaurin in Patients With Metastatic Breast Cancer Previously Treated With an Anthracycline and a Taxane-Containing Regimen

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

41

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Delaware
      • Newark, Delaware, United States, 19713
        • 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.
    • Indiana
      • 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
        • 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.
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • 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.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

October 6, 2006

First Submitted That Met QC Criteria

October 6, 2006

First Posted (Estimate)

October 11, 2006

Study Record Updates

Last Update Posted (Estimate)

June 6, 2008

Last Update Submitted That Met QC Criteria

June 5, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10517 (Other Identifier: CTEP)
  • H6Q-MC-S015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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