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

July 18, 2006 updated by: Eli Lilly and Company

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Ciudad De Buenos Aires, Argentina
    • Buenos Aires
      • Capital Federal, Buenos Aires, Argentina
  • Chile
    • Santiago
      • Las Condes, Santiago, Chile
      • Providencia, Santiago, Chile
  • India
    • Gujarat
      • Ahmedabab, Gujarat, India
  • Mexico
      • Colima, Mexico
    • Benito Juarez
      • Mexico City, Benito Juarez, Mexico
  • United States
    • Florida
      • Miami, Florida, United States
    • Louisiana
      • Shreveport, Louisiana, United States
    • Massachusetts
      • Boston, Massachusetts, United States
    • Tennessee
      • Nashville, Tennessee, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria

  1. Locally advanced or metastatic breast cancer
  2. Bi-dimensionally measurable disease

Exclusion Criteria

1. Prior hormonal therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

April 23, 2002

First Submitted That Met QC Criteria

April 23, 2002

First Posted (Estimate)

April 24, 2002

Study Record Updates

Last Update Posted (Estimate)

July 19, 2006

Last Update Submitted That Met QC Criteria

July 18, 2006

Last Verified

July 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3883
  • H4Z-MC-JWXD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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