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


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Neoplasms

Thank you

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