CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 2,980 enrolled
Drug / intervention
tamoxifen citrate +1 moredrug
Likely dose
Tamoxifen 20 mg orally daily OR Anastrozole 1 mg orally daily for 5 yearsAI-extracted
Key inclusion· 7
  • Diagnosis of ductal carcinoma in situ (DCIS) within the past 6 months
  • DCIS locally excised with tumor-free margins of at least 1 mm
  • Estrogen or progesterone receptor positive with ≥5% positive cells
  • Age 40 to 70 years old
Key exclusion· 13
  • Prior deep vein thrombosis (DVT)
  • Prior transient ischemic attack (TIA)
  • Prior cerebrovascular accident (stroke)
  • Prior pulmonary embolism

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00072462
NCT00072462Phase 3Completed

International Breast Cancer Intervention Study II (IBIS-II) (DCIS)

Queen Mary University of London·interventional·Posted Nov 6, 2003·Updated Sep 19, 2024

In Brief

A Phase 3 clinical trial evaluating tamoxifen citrate and Anastrozole for Breast Cancer. Completed, enrolled 2,980 participants across 97 sites in 14 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesAustralia, Austria, Belgium, Chile, France, Germany, Hungary, Ireland, Italy, Malta, Sweden, Switzerland, Turkey (Türkiye), United Kingdom
CollaboratorsCancer Research UK

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 6, 2003
Enrollment StartSep 1, 2003
Primary CompletionDec 1, 2015
Study CompletionMay 31, 2021
TodayJul 2, 2026
Enrollment to primary: 12.3 yearsPosted 22.7 years ago

Interventions

tamoxifen citratedrug

Tamoxifen 20mg + Anastrozole placebo

Anastrozoledrug

Anastrozole 1mg + Tamoxifen placebo