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| 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. |
Eligibility| 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
Contacts and 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 | |
More Information
| 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 |
|
cancer metastatic breast cancer hormonal therapy |
|
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 |
|
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 |