Tamoxifen for the Prevention of Breast Cancer in High-Risk Women

NCT00002644 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 7154

Last updated 2024-12-11

No results posted yet for this study

Summary

The International Breast Cancer Intervention Study I (IBIS-I) was designed to investigate the use of tamoxifen in preventing breast cancer in women with a higher risk of developing the disease. Recruitment of women to IBIS-I ended in March 2001 and it recruited 7154 women from 36 centres in 9 countries. The results of the study showed that tamoxifen reduced the incidence of breast cancer by one third in these high risk women but with some serious side effects. IBIS-II was designed to continue the work started in IBIS-I by examining the role of anastrozole in the prevention of breast cancer which we hope will reduce breast cancer by even more than tamoxifen with less serious side effects.

Conditions

Interventions

DRUG

Tamoxifen Citrate 20Mg Tab

Tamoxifen Citrate 20Mg Tab

OTHER

Placebo

Placebo 20Mg Tab

Sponsors & Collaborators

  • Queen Mary University of London

    lead OTHER

Principal Investigators

  • Jack Cuzick, PhD · Queen Mary University of London

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
1994-01-31
Primary Completion
2001-01-31
Completion
2011-03-30

Countries

  • United Kingdom

Study Locations

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Entities

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 NCT00002644 on ClinicalTrials.gov