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Study of Tamoxifen and Raloxifene (STAR) for the Prevention of Breast Cancer in Postmenopausal Women

NCT00003906 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 19747

Last updated 2015-10-06

No results posted yet for this study

Summary

RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using raloxifene and tamoxifen may fight breast cancer by blocking the uptake of estrogen by the tumor cells.

PURPOSE: Randomized double-blinded clinical trial to compare the effectiveness of raloxifene with that of tamoxifen in preventing breast cancer in postmenopausal women.

Conditions

Interventions

DRUG

Raloxifene

60 mg/day plus placebo for 5 years

DRUG

Tamoxifen

20 mg/day plus placebo for 5 years

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Eli Lilly and Company

    collaborator INDUSTRY

  • AstraZeneca

    collaborator INDUSTRY

  • NSABP Foundation Inc

    lead NETWORK

Principal Investigators

  • Norman Wolmark, MD · NSABP Foundation Inc

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-05-31
Primary Completion
2005-12-31
Completion
2012-08-31

Countries

  • United States
  • Canada
  • Puerto Rico

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00003906 on ClinicalTrials.gov