Phase 3 Study of LY353381 Vs Tamoxifen in Women With Locally Advanced or Metastatic Breast Cancer.
This study has been completed.
Sponsor:
Eli Lilly and Company
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00034125
First received: April 23, 2002
Last updated: July 18, 2006
Last verified: July 2006
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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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind 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| 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 | |
| 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
No publications provided
| ClinicalTrials.gov Identifier: | NCT00034125 History of Changes |
| Other Study ID Numbers: | 3883, H4Z-MC-JWXD |
| Study First Received: | April 23, 2002 |
| Last Updated: | July 18, 2006 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Eli Lilly and Company:
|
cancer metastatic breast cancer hormonal therapy |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms Neoplasms by Site Breast Diseases Skin Diseases Tamoxifen Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses |
Pharmacologic Actions Selective Estrogen Receptor Modulators Estrogen Receptor Modulators Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Bone Density Conservation Agents Estrogen Antagonists |
ClinicalTrials.gov processed this record on May 19, 2013