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

Sponsored by:	Institute of Cancer Research, United Kingdom
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00002644

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 III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control
Official Title:	INTERNATIONAL BREAST CANCER INTERVENTION STUDY: A MULTICENTRE TRIAL OF TAMOXIFEN TO PREVENT BREAST CANCER

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Tamoxifen Tamoxifen citrate

U.S. FDA Resources

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

Estimated Enrollment:	7000
Study Start Date:	January 1994

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

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

Locations

United Kingdom, England
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:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Cuzick J, Forbes JF, Sestak I, Cawthorn S, Hamed H, Holli K, Howell A; International Breast Cancer Intervention Study I Investigators. Long-term results of tamoxifen prophylaxis for breast cancer--96-month follow-up of the randomized IBIS-I trial. J Natl Cancer Inst. 2007 Feb 21;99(4):272-82.

Sestak I, Kealy R, Edwards R, Forbes J, Cuzick J. Influence of hormone replacement therapy on tamoxifen-induced vasomotor symptoms. J Clin Oncol. 2006 Aug 20;24(24):3991-6.

Cuzick J, Warwick J, Pinney E, Warren RM, Duffy SW. Tamoxifen and breast density in women at increased risk of breast cancer. J Natl Cancer Inst. 2004 Apr 21;96(8):621-8.

Cuzick J, Forbes J, Edwards R, Baum M, Cawthorn S, Coates A, Hamed A, Howell A, Powles T; IBIS investigators. First results from the International Breast Cancer Intervention Study (IBIS-I): a randomised prevention trial. Lancet. 2002 Sep 14;360(9336):817-24.

Cuzick J, Edwards R. Drop-outs in tamoxifen prevention trials. Lancet. 1999 Mar 13;353(9156):930. No abstract available.

Study ID Numbers:	CDR0000064151, NCRI-IBIS, EU-94041, UKCCCR-IBIS
Study First Received:	November 1, 1999
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00002644 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

breast cancer

Study placed in the following topic categories:

Estrogen Antagonists
Estrogens
Skin Diseases
Antineoplastic Agents, Hormonal
Hormone Antagonists
Citric Acid
Hormones, Hormone Substitutes, and Hormone Antagonists
Breast Neoplasms

Bone Density Conservation Agents
Selective Estrogen Receptor Modulators
Tamoxifen
Hormones
Estrogen Receptor Modulators
Citrate
Breast Diseases

Additional relevant MeSH terms:

Estrogen Antagonists
Skin Diseases
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Breast Neoplasms
Bone Density Conservation Agents

Selective Estrogen Receptor Modulators
Tamoxifen
Pharmacologic Actions
Estrogen Receptor Modulators
Neoplasms
Neoplasms by Site
Therapeutic Uses
Breast Diseases

ClinicalTrials.gov processed this record on July 02, 2009