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Completed

NCT Number: NCT00386087

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

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

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Key information

Conditions

Breast Neoplasms Breast Diseases Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary 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., Newark, Delaware, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enzastaurin Hydrochloride

Drug

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.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Study completion
2007
First posted
Oct 11, 2006
Registry last updated
Jun 6, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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