View Clinical Trial (Medical Research Study)

Anastrozole in Preventing Breast Cancer in Postmenopausal Women at Increased Risk of Breast Cancer - NCT00078832-Concepcion - 0019(Clinical Trial 119462)



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City:  Concepcion
Country:  
Chile
Conditions: Breast Cancer
Purpose: RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. Anastrozole may be effective in preventing breast cancer. PURPOSE: This randomized clinical trial is studying how well anastrozole works in preventing breast cancer in postmenopausal women who are at increased risk for the disease.
Study summary: OBJECTIVES: Primary - Determine the effectiveness of anastrozole in preventing breast cancer in postmenopausal women at increased risk for the disease. Secondary - Determine the role of this drug in preventing estrogen receptor-positive breast cancer in these participants. - Determine the effect of this drug on breast cancer mortality in these participants. - Determine the effect of this drug on other cancers, cardiovascular disease, fracture rates, and non-breast cancer deaths in these participants. - Determine the tolerability and acceptability of side effects of this drug in these participants. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Participants are stratified according to participating center. Participants are randomized to 1 of 2 treatment arms. - Arm I: Participants receive oral anastrozole daily for 5 years. - Arm II: Participants receive an oral placebo daily for 5 years. In both arms, treatment continues in the absence of the development of breast cancer (including ductal carcinoma in situ), a drop in the T-score below minus 4, or the occurrence of a new fragility fracture. Participants are followed for 5 years. Peer Reviewed and Funded or Endorsed by Cancer Research UK PROJECTED ACCRUAL: A total of 6,000 participants will be accrued for this study.
Criteria: DISEASE CHARACTERISTICS: - Meets at least 1 of the relative risk factors based on age as follows: - 45 to 70 years of age: - First-degree relative who developed breast cancer at ≤ 50 years of age - First-degree relative who developed bilateral breast cancer - Two or more first- or second-degree relatives who developed breast cancer or ovarian cancer - Participants having both relatives who are second degree and on the opposite sides of the family must have at least one that was diagnosed at ≤ 50 years of age - Nulliparous (or first birth at ≥ 30 years of age) and a first-degree relative who developed breast cancer - Benign biopsy with proliferative disease and a first-degree relative who developed breast cancer - Mammographic opacity covering at least 50% of the breast in the absence of hormone replacement therapy within the past 3 months - 60 to 70 years of age: - First-degree relative with breast cancer at any age - Age at menopause ≥ 55 years - Nulliparous or age at first birth ≥ 30 years - 40 to 44 years of age: - Two or more first- or second-degree relatives who developed breast cancer or ovarian cancer at ≤ 50 years of age - First-degree relative with bilateral breast cancer who developed the first breast cancer at ≤ 50 years of age - Nulliparous (or first birth at ≥ 30 years of age) and a first-degree relative who developed breast cancer at ≤ 40 years of age - Benign biopsy with proliferative disease and a first-degree relative who developed breast cancer at ≤ 40 years of age - All age groups (40 to 70 ears of age) with a 10-year risk > 5% who do not fit into the above categories are allowed - Clearly apparent family history AND/OR other risk factors indicating appropriate increased risk of breast cancer for age - The following prior breast conditions are allowed (for all age groups): - Lobular carcinoma in situ - Atypical ductal or lobular hyperplasia in a benign lesion - Ductal carcinoma in-situ (DCIS), diagnosed within the past 6 months, and treated by mastectomy - No evidence of breast cancer on mammogram within the past year - Hormone receptor status: - For patients with prior DCIS, estrogen- or progesterone-receptor status must have been positive - Must have had > 5% positive cells PATIENT CHARACTERISTICS: Age - 40 to 70 Sex - Female Menopausal status - Postmenopausal, defined as at least 1 of the following: - Over 60 years of age - Bilateral oophorectomy - ≤ 60 years of age with a uterus and amenorrhea for at least 12 months - ≤ 60 years of age without a uterus and with follicle-stimulating hormone levels > 30 IU/L Performance status - Not specified Life expectancy - At least 10 years Hematopoietic - Not specified Hepatic - Not specified Renal - Not specified Other - Psychologically and physically suitable to receive 5 years of anti-estrogen therapy - No cancer within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix - No evidence of osteoporosis or fragility fractures within the spine - Participants with a T-score > minus 4 and no more than 2 fragility fractures are allowed - No concurrent severe disease that would place the participant at unusual risk or confound the results of the study - No other medical condition that would preclude the ability to receive the study treatment PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - No prior tamoxifen, raloxifene, or other selective estrogen receptor modulator (SERM) use for more than 3 months in duration - No concurrent tamoxifen, raloxifene, or other SERM - No concurrent estrogen-based hormone replacement therapy - No concurrent systemic estrogen replacement therapy, including vaginal estrogen preparations Radiotherapy - Not specified Surgery - See Disease Characteristics - No prior prophylactic mastectomy - No concurrent prophylactic mastectomy Other - More than 3 months since prior investigational drugs - No prior participation in IBIS-I - No concurrent participation in IBIS-I
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Data Source: ClinicalTrials.gov
Date Processed: February 15, 2010
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