- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00034125
Phase 3 Study of LY353381 Vs Tamoxifen in Women With Locally Advanced or Metastatic Breast Cancer.
July 18, 2006 updated by: Eli Lilly and Company
a Phase 3 Randomized Double Blind Evaluation of LY353381 Compared With Tamoxifen in Women With Locally Advanced or Metastatic Breast Cancer.
To determine the safety and efficacy of LY353381 when compared to tamoxifen in women with advanced or metastatic breast cancer.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ciudad De Buenos Aires, Argentina
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Buenos Aires
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Capital Federal, Buenos Aires, Argentina
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Santiago
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Las Condes, Santiago, Chile
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Providencia, Santiago, Chile
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Gujarat
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Ahmedabab, Gujarat, India
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Colima, Mexico
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Benito Juarez
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Mexico City, Benito Juarez, Mexico
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Florida
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Miami, Florida, United States
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Louisiana
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Shreveport, Louisiana, United States
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Massachusetts
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Boston, Massachusetts, United States
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Tennessee
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Nashville, Tennessee, United States
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria
- Locally advanced or metastatic breast cancer
- Bi-dimensionally measurable disease
Exclusion Criteria
1. Prior hormonal therapy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
April 23, 2002
First Submitted That Met QC Criteria
April 23, 2002
First Posted (Estimate)
April 24, 2002
Study Record Updates
Last Update Posted (Estimate)
July 19, 2006
Last Update Submitted That Met QC Criteria
July 18, 2006
Last Verified
July 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Antineoplastic Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Hormone Antagonists
- Bone Density Conservation Agents
- Estrogen Antagonists
- Selective Estrogen Receptor Modulators
- Estrogen Receptor Modulators
- Tamoxifen
Other Study ID Numbers
- 3883
- H4Z-MC-JWXD
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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GlaxoSmithKlineCompletedMetastatic Breast Cancer | Neoplasms, BreastJapan
Clinical Trials on tamoxifen
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Institut Cancerologie de l'OuestActive, not recruiting
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Northwestern UniversityNational Cancer Institute (NCI)CompletedEstrogen Receptor-positive Breast Cancer | Ductal Breast Carcinoma in SituUnited States
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Seoul National University HospitalActive, not recruitingHormone Receptor-positive Breast Cancer | Premenopausal Breast CancerKorea, Republic of
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European Institute of OncologyIstituto Oncologico Veneto IRCCS; Ente Ospedaliero Ospedali Galliera; Istituto...Not yet recruitingDuctal Carcinoma in Situ | RAD51C Gene Mutation | RAD51D Gene Mutation | PALB2 Gene Mutation | Lobular Carcinoma in Situ | ATM Gene Mutation | CDH1 Gene Mutation | CHEK2 Gene Mutation | BRCA MutationItaly
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ECOG-ACRIN Cancer Research GroupNational Cancer Institute (NCI)CompletedBreast Cancer | Stage IV Breast CancerUnited States, Canada, Peru
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National Cancer Center, KoreaUnknown
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Northwestern UniversityNational Cancer Institute (NCI); BHR Pharma, LLCRecruitingEstrogen Receptor Positive | Ductal Breast Carcinoma In SituUnited States
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The Methodist Hospital Research InstituteMillennium Pharmaceuticals, Inc.CompletedEstrogen Receptor Positive Breast CancerUnited States
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Kafrelsheikh UniversityNot yet recruiting
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TYK Medicines, IncRecruiting