Tamoxifen for the Prevention of Breast Cancer in High-Risk Women
|ClinicalTrials.gov Identifier: NCT00002644|
Recruitment Status : Completed
First Posted : May 11, 2004
Last Update Posted : September 20, 2013
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen.
PURPOSE: Randomized double-blinded phase III trial to compare the effectiveness of tamoxifen with a placebo in preventing breast cancer in women at high risk.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: tamoxifen citrate||Phase 3|
OBJECTIVES: I. Evaluate whether tamoxifen taken daily for 5 years reduces the incidence of and mortality from breast cancer in high-risk women. II. Assess the risks and benefits of this intervention.
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Participants are stratified by participating institution. Participants are randomly assigned to receive either oral tamoxifen or oral placebo every day for 5 years in the absence of breast cancer development or pregnancy. Participants are followed every 6 months for 5 years; then annually for 5 years. Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: 7,000 women will be entered at a rate of 200-500 women/institution/5 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||7000 participants|
|Official Title:||INTERNATIONAL BREAST CANCER INTERVENTION STUDY: A MULTICENTRE TRIAL OF TAMOXIFEN TO PREVENT BREAST CANCER|
|Study Start Date :||January 1994|
|Study Completion Date :||May 2011|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002644
|Imperial Cancer Research Fund|
|London, England, United Kingdom, WC2A 3PX|
|Study Chair:||Jack Cuzick, PhD||Cancer Research UK|