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CompletedNCT00386087Updated Jun 6, 2008

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

A Phase 2 interventional study of Enzastaurin Hydrochloride in Breast Neoplasms, sponsored by Eli Lilly and Company. Completed at 4 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-06-06.

Sponsored by Eli Lilly and Company · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
41
Allocation
Non-randomized
Ages
18 Years and older
Sex
Female
01

Study summary

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

02

Conditions studied

  • Breast Neoplasms

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Keywords

  • Breast Cancer
  • Cancer of the Breast
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 41 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
41 participants (estimated)

Interventions

  • DrugEnzastaurin Hydrochloride
06

What researchers measure

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

  1. To evaluate the length of time that enzastaurin is able to effect control of the disease.

  2. To evaluate the side effects of enzastaurin in patients with breast cancer

  3. To determine whether changes in laboratory tests of patients treated with enzastaurin is associated with the response of their tumors to the drug.

07

Study locations

4 sites
  • 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
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 6, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00386087
Lead sponsor
Eli Lilly and Company
First posted
Oct 11, 2006
Start date
Nov 2006
Completion
Sep 2007
Last update
Jun 6, 2008

Study contacts

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)
study director · Eli Lilly and Company
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2008. You cannot join it, but the record below documents what was studied.

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