A Phase II Study of Oral Enzastaurin in Patients With Metastatic Breast Cancer Previously Treated With an Anthracycline and a Taxane-Containing Regimen
18 Years
N/A
Female
Breast Neoplasms
Trial Information
A Phase II Study of Oral Enzastaurin in Patients With Metastatic Breast Cancer Previously Treated With an Anthracycline and a Taxane-Containing Regimen
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
Principal Investigator
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)
Investigator Role:
Study Director
Investigator Affiliation:
Eli Lilly and Company
Authority:
United States: Food and Drug Administration
Study ID:
10517
NCT ID:
NCT00386087
Start Date:
November 2006
Completion Date:
September 2007
Related Keywords:
- Breast Neoplasms
- Breast Cancer
- Cancer of the Breast
- Breast Neoplasms
- Neoplasms
Name | Location |
|---|---|
| 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 46227 |
| 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 |
| 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. | Springfield, Massachusetts |
