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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00002644
First received: November 1, 1999
Last updated: September 19, 2013
Last verified: July 2011
  Purpose

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 Intervention Phase
Breast Cancer
Drug: tamoxifen citrate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: INTERNATIONAL BREAST CANCER INTERVENTION STUDY: A MULTICENTRE TRIAL OF TAMOXIFEN TO PREVENT BREAST CANCER

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 7000
Study Start Date: January 1994
Study Completion Date: May 2011
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.

  Eligibility

Ages Eligible for Study:   35 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002644

Locations
United Kingdom
Imperial Cancer Research Fund
London, England, United Kingdom, WC2A 3PX
Sponsors and Collaborators
Institute of Cancer Research, United Kingdom
Investigators
Study Chair: Jack Cuzick, PhD Cancer Research UK
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00002644     History of Changes
Other Study ID Numbers: CDR0000064151, NCRI-IBIS, EU-94041, UKCCCR-IBIS
Study First Received: November 1, 1999
Last Updated: September 19, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Tamoxifen
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Selective Estrogen Receptor Modulators
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 30, 2014