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

Tracking Information
First Received Date ^ICMJE	April 23, 2002
Last Updated Date	July 18, 2006
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00034125 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Phase 3 Study of LY353381 Vs Tamoxifen in Women With Locally Advanced or Metastatic Breast Cancer.
Official Title ^ICMJE	a Phase 3 Randomized Double Blind Evaluation of LY353381 Compared With Tamoxifen in Women With Locally Advanced or Metastatic Breast Cancer.
Brief Summary	To determine the safety and efficacy of LY353381 when compared to tamoxifen in women with advanced or metastatic breast cancer.
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Active Control, Single Group Assignment, Safety/Efficacy Study
Condition ^ICMJE	Breast Neoplasms
Intervention ^ICMJE	Drug: LY353381 Drug: tamoxifen
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria Locally advanced or metastatic breast cancer Bi-dimensionally measurable disease Exclusion Criteria 1. Prior hormonal therapy
Gender	Female
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Argentina, Chile, India, Mexico

Administrative Information
NCT ID ^ICMJE	NCT00034125
Responsible Party
Study ID Numbers ^ICMJE	3883, H4Z-MC-JWXD
Study Sponsor ^ICMJE	Eli Lilly and Company
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Eli Lilly and Company
Verification Date	July 2006
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP