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Sponsored by: |
Eli Lilly and Company |
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Information provided by: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT00034125 |
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. |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
1. Prior hormonal therapy
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 |
Study ID Numbers: | 3883, H4Z-MC-JWXD |
Study First Received: | April 23, 2002 |
Last Updated: | July 18, 2006 |
ClinicalTrials.gov Identifier: | NCT00034125 |
Health Authority: | United States: Food and Drug Administration |
cancer metastatic breast cancer hormonal therapy |
Skin Diseases Breast Neoplasms Tamoxifen Breast Diseases |
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 |