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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002644
Recruitment Status : Completed
First Posted : May 11, 2004
Last Update Posted : September 20, 2013
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: tamoxifen citrate Phase 3

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 7000 participants
Allocation: Randomized
Masking: Double
Primary Purpose: Prevention
Study Start Date : January 1994
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00002644

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

Publications of Results:
Other Publications: Identifier: NCT00002644     History of Changes
Other Study ID Numbers: CDR0000064151
First Posted: May 11, 2004    Key Record Dates
Last Update Posted: September 20, 2013
Last Verified: July 2011

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

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