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NCT00034125 Clinical Trial

Phase 3 Study of LY353381 Vs Tamoxifen in Women With Locally Advanced or Metastatic Breast Cancer.

Breast Neoplasms Clinical Trial

Official title:
a Phase 3 Randomized Double Blind Evaluation of LY353381 Compared With Tamoxifen in Women With Locally Advanced or Metastatic Breast Cancer.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00034125
Other study ID # 3883
Secondary ID H4Z-MC-JWXD
Status Completed
Phase Phase 3
First received April 23, 2002
Last updated July 18, 2006

Study information
Verified date July 2006
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

To determine the safety and efficacy of LY353381 when compared to tamoxifen in women with advanced or metastatic breast cancer.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria

1. Locally advanced or metastatic breast cancer

2. Bi-dimensionally measurable disease

Exclusion Criteria

1. Prior hormonal therapy

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• LY353381

• tamoxifen

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Argentina,  Chile,  India,  Mexico, 

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