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Home > "T" Clinical Trials Conditions > Tamoxifen for the Prevention of Breast Cancer in High-Risk Women  Tamoxifen for the Prevention of Breast Cancer in High-Risk Women
Tamoxifen for the Prevention of Breast Cancer in High-Risk Women
For Condition: prevention of breast cancer,Breast Cancer
Status: No longer recruiting
Sponsor(s): United Kingdom Coordinating Committee on Cancer Research ,
Synopsis: 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.
Details: 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. PROTOCOL 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. PROJECTED ACCRUAL: 7,000 women will be entered at a rate of 200-500 women/institution/5 years.
Eligibility:
Study Type: Interventional, Prevention
Minimum Age/Maximum Age: 35 Years/70 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Population Characteristics-- - Women with at least 1 risk factor for developing breast cancer, as follows: Ages 45-70 (with at least a 2-fold risk): First-degree relative developed breast cancer at age 50 or less; First-degree relative developed bilateral breast cancer 2 or more first- or second-degree relatives developed breast cancer; Nulliparous and a first-degree relative developed breast cancer; Benign biopsy with proliferative disease and a first-degree relative developed breast cancer; Lobular carcinoma in situ; Atypical ductal or lobular hyperplasia in a benign lesion - Ages 40-44 (with at least a 4-fold risk) *: 2 or more first- or second-degree relatives developed breast cancer at age 50 or less; First-degree relative with bilateral breast cancer developed the first breast cancer at age 50 or less; Nulliparous and a first-degree relative developed breast cancer at age 40 or less; Benign biopsy with proliferative disease and a first-degree relative developed breast cancer at age 40 or less; Lobular carcinoma in situ; Atypical ductal or lobular hyperplasia in a benign lesion - Ages 35-39 (with at least a 10-fold risk) *: 2 or more first-degree relatives developed breast cancer at age 50 or less; First-degree relative with bilateral breast cancer developed the first breast cancer at age 40 or less; Lobular carcinoma in situ - Entry of women who do not fit into these categories but with a clearly apparent family history indicating appropriate risk requires approval of the Working Party Chairman - No malignant disease on mammogram with, as indicated, fine-needle biopsy or cytology within 1 year prior to entry --Prior/Concurrent Therapy-- - Hormone replacement therapy for menopausal symptoms allowed at lowest effective dose; Not currently on tamoxifen; Not currently on anticoagulants --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JackCuzick, Study Chair, United Kingdom Coordinating Committee on Cancer Research
Imperial Cancer Research Fund
London, England, WC2A 3PX
United Kingdom
Additional Information:
Study ID Numbers: CDR0000064151; UKCCCR-IBIS,EU-94041
Study Start Date: January 1994
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002644
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Tamoxifen for the Prevention of Breast Cancer in High-Risk Women
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