Enzastaurin For Breast Cancer Patients Who Previously Received an Anthracycline and a Taxane Chemotherapy
A Phase II Study of Oral Enzastaurin in Patients With Metastatic Breast Cancer Previously Treated With an Anthracycline and a Taxane-Containing Regimen
2 other identifiers
interventional
41
1 country
4
Brief Summary
The purpose of this study is to determine the effectiveness of enzastaurin in the treatment of patients with metastatic breast cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Nov 2006
Shorter than P25 for phase_2
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 6, 2006
CompletedFirst Posted
Study publicly available on registry
October 11, 2006
CompletedStudy Start
First participant enrolled
November 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2007
CompletedJune 6, 2008
April 1, 2008
October 6, 2006
June 5, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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.
Newark, Delaware, 19713, United States
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, 46202, United States
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, 46601, United States
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, 02115, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 6, 2006
First Posted
October 11, 2006
Study Start
November 1, 2006
Study Completion
September 1, 2007
Last Updated
June 6, 2008
Record last verified: 2008-04