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Adjuvant Tamoxifen Compared With Anastrozole in Treating Postmenopausal Women With Ductal Carcinoma In Situ

NCT00072462 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2980

Last updated 2024-09-19

Study results available
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Summary

RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using either tamoxifen or anastrozole may fight breast cancer by blocking the use of estrogen. It is not yet known whether tamoxifen is more effective than anastrozole in preventing breast cancer after surgery for ductal carcinoma in situ.

PURPOSE: This randomized phase III trial is studying how well adjuvant tamoxifen works compared to anastrozole in treating postmenopausal women who have undergone surgery to remove ductal carcinoma in situ.

Conditions

Interventions

DRUG

tamoxifen citrate

Tamoxifen 20mg + Anastrozole placebo

DRUG

Anastrozole

Anastrozole 1mg + Tamoxifen placebo

Sponsors & Collaborators

Principal Investigators

  • Jack Cuzick, PhD · Queen Mary University of London

  • Anthony Howell · University of Manchester

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2003-09-30
Primary Completion
2015-12-31
Completion
2021-05-31

Countries

  • Australia
  • Austria
  • Belgium
  • Chile
  • France
  • Germany
  • Hungary
  • Ireland
  • Italy
  • Malta
  • Sweden
  • Switzerland
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

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 NCT00072462 on ClinicalTrials.gov