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

Tracking Information

First Received Date ^ICMJE

November 1, 1999

Last Updated Date

July 23, 2008

Start Date ^ICMJE

January 1994

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00002644 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

INTERNATIONAL BREAST CANCER INTERVENTION STUDY: A MULTICENTRE TRIAL OF TAMOXIFEN TO PREVENT BREAST CANCER

Brief Summary

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.

Detailed Description

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 Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Double-Blind, Placebo Control

Condition ^ICMJE

Breast Cancer

Intervention ^ICMJE

Drug: tamoxifen citrate

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

7000

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

DISEASE CHARACTERISTICS: See General Eligibility Criteria

PATIENT CHARACTERISTICS: Age: 35 to 70 Sex: Women only Menopausal status: Pre-, peri-, or postmenopausal Performance status: Not specified Life expectancy: At least 10 years Cardiovascular: No prior deep vein thrombosis Pulmonary: No prior pulmonary embolus Other: Psychologically and physically able to undertake therapy for 5 years No other medical condition more serious than risk of breast cancer No prior cancer except: Nonmelanomatous skin cancer In situ cancer of the cervix No pregnant women Effective nonhormonal contraception required of fertile women

PRIOR CONCURRENT THERAPY: Hormone replacement therapy for menopausal symptoms allowed at lowest effective dose Not currently on tamoxifen Not currently on anticoagulants

Gender

Female

Ages

35 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00002644

Responsible Party

Study ID Numbers ^ICMJE

CDR0000064151, NCRI-IBIS, EU-94041, UKCCCR-IBIS

Study Sponsor ^ICMJE

Institute of Cancer Research, United Kingdom

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Jack Cuzick, PhD

Cancer Research UK

Information Provided By

National Cancer Institute (NCI)

Verification Date

May 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP