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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00034125
Recruitment Status : Completed
First Posted : April 24, 2002
Last Update Posted : July 19, 2006
Information provided by:
Eli Lilly and Company

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

Condition or disease Intervention/treatment Phase
Breast Neoplasms Drug: LY353381 Drug: tamoxifen Phase 3

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
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 the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria

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

Exclusion Criteria

1. Prior hormonal therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00034125

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
Capital Federal, Buenos Aires, Argentina
Ciudad De Buenos Aires, Argentina
Las Condes, Santiago, Chile
Providencia, Santiago, Chile
Ahmedabab, Gujarat, India
Mexico City, Benito Juarez, Mexico
Colima, Mexico
Sponsors and Collaborators
Eli Lilly and Company

ClinicalTrials.gov Identifier: NCT00034125     History of Changes
Other Study ID Numbers: 3883
First Posted: April 24, 2002    Key Record Dates
Last Update Posted: July 19, 2006
Last Verified: July 2006

Keywords provided by Eli Lilly and Company:
metastatic breast cancer
hormonal therapy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents