NCT00034125

Brief Summary

To determine the safety and efficacy of LY353381 when compared to tamoxifen in women with advanced or metastatic breast cancer.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
5 countries

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 24, 2002

Completed
Last Updated

July 19, 2006

Status Verified

July 1, 2006

First QC Date

April 23, 2002

Last Update Submit

July 18, 2006

Conditions

Breast Neoplasms

Keywords

cancermetastatic breast cancerhormonal therapy

Interventions

LY353381DRUG
tamoxifenDRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Locally advanced or metastatic breast cancer
  • Bi-dimensionally measurable disease

You may not qualify if:

  • \. Prior hormonal therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Unknown Facility

Miami, Florida, United States

Location

Unknown Facility

Shreveport, Louisiana, United States

Location

Unknown Facility

Boston, Massachusetts, United States

Location

Unknown Facility

Nashville, Tennessee, United States

Location

Unknown Facility

Capital Federal, Buenos Aires, Argentina

Location

Unknown Facility

Ciudad de Buenos Aires, Buenos Aires F.D., Argentina

Location

Unknown Facility

Las Condes, Santiago Metropolitan, Chile

Location

Unknown Facility

Providencia, Santiago Metropolitan, Chile

Location

Unknown Facility

Ahmedabab, Gujarat, India

Location

Unknown Facility

Mexico City, Benito Juarez, Mexico

Location

Unknown Facility

Colima, Colima, Mexico

Location

MeSH Terms

Conditions

Breast NeoplasmsNeoplasms

Interventions

LY 353381Tamoxifen

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

StilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 23, 2002

First Posted

April 24, 2002

Last Updated

July 19, 2006

Record last verified: 2006-07

Locations

IN(1)ME(2)AR(2)CL(2)US(4)