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

NCT ID: NCT00386087

Last Updated: 2008-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2007-09-30

Brief Summary

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

Detailed Description

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Conditions

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Breast Neoplasms

Keywords

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Breast Cancer Cancer of the Breast

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Enzastaurin Hydrochloride

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Principal Investigators

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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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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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

Site Status

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

Site Status

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

Site Status

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

Site Status

Countries

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United States

Related Links

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Other Identifiers

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H6Q-MC-S015

Identifier Type: -

Identifier Source: secondary_id

10517

Identifier Type: -

Identifier Source: org_study_id