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

This study has been completed.

First Received: April 23, 2002 Last Updated: July 18, 2006 History of Changes

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00034125

Purpose

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

Condition	Intervention	Phase
Breast Neoplasms	Drug: LY353381 Drug: tamoxifen	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	a Phase 3 Randomized Double Blind Evaluation of LY353381 Compared With Tamoxifen in Women With Locally Advanced or Metastatic Breast Cancer.

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Tamoxifen Tamoxifen citrate Arzoxifene

U.S. FDA Resources

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

Locally advanced or metastatic breast cancer
Bi-dimensionally measurable disease

Exclusion Criteria

1. Prior hormonal therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00034125

Locations

United States, Florida

Miami, Florida, United States
United States, Louisiana

Shreveport, Louisiana, United States
United States, Massachusetts

Boston, Massachusetts, United States
United States, Tennessee

Nashville, Tennessee, United States
Argentina

Ciudad De Buenos Aires, Argentina
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
Mexico, Benito Juarez

Mexico City, Benito Juarez, Mexico

Sponsors and Collaborators

Eli Lilly and Company

More Information

No publications provided

Study ID Numbers:	3883, H4Z-MC-JWXD
Study First Received:	April 23, 2002
Last Updated:	July 18, 2006
ClinicalTrials.gov Identifier:	NCT00034125 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:

cancer
metastatic breast cancer
hormonal therapy

Study placed in the following topic categories:

Estrogens
Estrogen Antagonists
Skin Diseases
Antineoplastic Agents, Hormonal
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Breast Neoplasms

Bone Density Conservation Agents
Selective Estrogen Receptor Modulators
Tamoxifen
Hormones
Estrogen Receptor Modulators
Breast Diseases

Additional relevant MeSH terms:

Estrogen Antagonists
Skin Diseases
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Breast Neoplasms
Bone Density Conservation Agents

Selective Estrogen Receptor Modulators
Tamoxifen
Pharmacologic Actions
Estrogen Receptor Modulators
Neoplasms
Neoplasms by Site
Therapeutic Uses
Breast Diseases

ClinicalTrials.gov processed this record on July 02, 2009