Tamoxifen for the Prevention of Breast Cancer in High-Risk Women
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|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|
|Actual Study Completion Date :||May 2011|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|