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Home > "A" Clinical Trials Conditions > Anastrozole in Preventing Breast Cancer in Postmenopausal Women at Increased Risk of Breast Cancer  Anastrozole in Preventing Breast Cancer in Postmenopausal Women at Increased Risk of Breast Cancer
Anastrozole in Preventing Breast Cancer in Postmenopausal Women at Increased Risk of Breast Cancer
For Condition: Breast Cancer
Status: Recruiting
Sponsor(s): Cancer Research UK ,
Synopsis: 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: Randomized clinical trial to study the effectiveness of anastrozole in preventing breast cancer in postmenopausal women who are at increased risk for the disease.
Details: 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 occurence of a new fragility fracture. Participants are followed for 5 years. PROJECTED ACCRUAL: A total of 6,000 participants will be accrued for this study.
Eligibility:
Study Type: Interventional, Prevention
Minimum Age/Maximum Age: 40 Years/70 Years
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JackCuzick, , Cancer Research UK
Saint Margaret's Hospital *Recruiting*
Epping Essex, England, CM16 6TN
United Kingdom
Recruiting Contact Person 44-019-9290-2010
Chelmsford and Essex Centre *Recruiting*
Chelsmford Essex, England, CM2 0QH
United Kingdom
Recruiting Contact Person 44-012-4549-1149
Leeds General Infirmary at Leeds Teaching Hospital NHS Trust *Recruiting*
Leeds, England, LS1 3EX
United Kingdom
Recruiting Contact Person 44-113-243-2799
Queen Elizabeth Hospital at University of Birmingham *Recruiting*
Birmingham, England, B15 2TH
United Kingdom
Recruiting Contact Person 44-012-1472-1311
Royal Liverpool and Broadgreen Hospitals *Recruiting*
Liverpool, England, L7 8XP
United Kingdom
Recruiting Contact Person 44-151-706-4363
Bristol Haematology and Oncology Centre *Recruiting*
Bristol, England, BS2 8ED
United Kingdom
Recruiting Contact Person 44-117-923-0000
Western General Hospital *Recruiting*
Edinburgh, Scotland, EH4 2XU
United Kingdom
Recruiting Contact Person 44-131-537-1000
University of Wales College of Medicine *Recruiting*
Cardiff, Wales, CF14 4XN
United Kingdom
Recruiting Contact Person 44-29-2074-7747
Frenchay Hospital *Recruiting*
Bristol, England, BS16 1LE
United Kingdom
Recruiting Contact Person 44-011-7970-1212
Yeovil District Hospital *Recruiting*
Yeovil - Somerset, England, BA21 4AT
United Kingdom
Recruiting Contact Person 44-019-354-5122
Cancer Research UK *Recruiting*
London, England, WC2A 3PX
United Kingdom
Recruiting Jack Cuzick 44-20-7269-3006
Guy's and St. Thomas' Hospitals NHS Trust *Recruiting*
London, England, SE1 9RT
United Kingdom
Recruiting Contact Person 44-207-955-5000
Northwick Park Hospital *Recruiting*
Harrow, England, HA1 3UJ
United Kingdom
Recruiting Contact Person 44-0208-869-2085
Derby City General Hospital *Recruiting*
Derby, England, DE22 3NE
United Kingdom
Recruiting Contact Person 44-013-3234-0131
Royal Cornwall Hospital *Recruiting*
Truro, Cornwall, England, TR1 3LJ
United Kingdom
Recruiting Contact Person 44-018-7225-0000
Castle Hill Hospital, Cottingham *Recruiting*
Cottingham, England, HU16 5JQ
United Kingdom
Recruiting Contact Person 44-0148-262-3500
Nottingham City Hospital NHS Trust *Recruiting*
Nottingham, England, NG5 1PB
United Kingdom
Recruiting Contact Person 44-011-5969-1169
South And East Dorset Primary Care Trust *Recruiting*
Ferndown Dorset, England, BH22 9JR
United Kingdom
Recruiting Contact Person 44-012-0285-0600
Withington Hospital *Recruiting*
Manchester, England, M20 8LR
United Kingdom
Recruiting Contact Person 44-16-1445-8111
Royal South Hants Hospital *Recruiting*
Southampton, England, SO14 6YG
United Kingdom
Recruiting Contact Person 44-238-8077-7222
St. James's University Hospital *Recruiting*
Leeds, England, LS9 7TF
United Kingdom
Recruiting Contact Person 44-113-206-4904
Additional Information:
Study ID Numbers: CDR0000353186; EU-20227,CRUK-IBIS-IIB
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00078832
Other Breast Cancer Studies:
1. Allogeneic (Donor) Bone Marrow Transplant to Treat Breast Cancer
2. Itraconazole Compared With Fluconazole to Prevent Infections in Patients Undergoing Peripheral Stem Cell or Bone Marrow Transplantation
3. A Phase I Trial of Continuous Infusion UCN-01 in Patients with Refractory Neoplasms
4. Safety Study of hMN14 to Treat Either Colorectal or Breast Cancer
5. Diet and Estrogen Metabolism in Postmenopausal Women
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Anastrozole in Preventing Breast Cancer in Postmenopausal Women at Increased Risk of Breast Cancer
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