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

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

This study has been completed.

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

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

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.

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

Study ID Numbers:	3883, H4Z-MC-JWXD
First Received:	April 23, 2002
Last Updated:	July 18, 2006
ClinicalTrials.gov Identifier:	NCT00034125
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:

Skin Diseases

Breast Neoplasms

Tamoxifen

Breast Diseases

Additional relevant MeSH terms:

Estrogen Antagonists

Antineoplastic Agents, Hormonal

Antineoplastic Agents

Hormone Antagonists

Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists

Bone Density Conservation Agents

Selective Estrogen Receptor Modulators

Pharmacologic Actions

Estrogen Receptor Modulators

Neoplasms

Neoplasms by Site

Therapeutic Uses

ClinicalTrials.gov processed this record on October 24, 2008