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

NCT ID: NCT00034125

Last Updated: 2006-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Brief Summary

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

Detailed Description

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Conditions

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Breast Neoplasms

Keywords

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cancer metastatic breast cancer hormonal therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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LY353381

Intervention Type DRUG

tamoxifen

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1\. Prior hormonal therapy
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Locations

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Miami, Florida, United States

Site Status

Shreveport, Louisiana, United States

Site Status

Boston, Massachusetts, United States

Site Status

Nashville, Tennessee, United States

Site Status

Capital Federal, Buenos Aires, Argentina

Site Status

Ciudad de Buenos Aires, Buenos Aires F.D., Argentina

Site Status

Las Condes, Santiago Metropolitan, Chile

Site Status

Providencia, Santiago Metropolitan, Chile

Site Status

Ahmedabab, Gujarat, India

Site Status

Mexico City, Benito Juarez, Mexico

Site Status

Colima, Colima, Mexico

Site Status

Countries

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United States Argentina Chile India Mexico

Other Identifiers

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H4Z-MC-JWXD

Identifier Type: -

Identifier Source: secondary_id

3883

Identifier Type: -

Identifier Source: org_study_id