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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00034125
First Posted: April 24, 2002
Last Update Posted: July 19, 2006
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.
Information provided by:
Eli Lilly and Company
  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 3

Study Type: Interventional
Study Design: 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 NLM:


Further study details as provided by Eli Lilly and Company:

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria

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

Exclusion Criteria

1. Prior hormonal therapy

  Contacts and Locations
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


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

ClinicalTrials.gov Identifier: NCT00034125     History of Changes
Other Study ID Numbers: 3883
H4Z-MC-JWXD
First Submitted: April 23, 2002
First Posted: April 24, 2002
Last Update Posted: July 19, 2006
Last Verified: July 2006

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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Tamoxifen
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