None listed
Conditions
Interventions
Anastrozole 1 mg placebo will be administered.
Group name:Anastrozole Type of group
Anastrozole 1 mg daily will be given for 5 years
Sponsors
ASTRAZENECA - PERU,
Eligibility
Inclusion criteria
Inclusion criteria: a) All women must be post-menopausal and between 40 and 70 years old. The post-menopausal state is defined as 1 or more of the following criteria: 1. Greater than 60 years. 2. Bilateral opectoctomy. 3. Under 60 years of age with uterus and amenorrhea of at least 12 months. 4. Under 60 years without uterus and with FSH> 20 Ul / L. c) A mammogram must have been taken in the last year and must not be show some evidence of breast cancer. d) Having baseline bone densitometry within the last 2 years (DXA of any cadeVa, lumbar spine and forearm), is required in all women. Column radiography to rule out fragility or fractures will also be required. e) Obtaining signed informed consent.
Exclusion criteria
Exclusion criteria: a) Pre-menopausal woman. b) Any previous cancer in the last 6 years (except non-melanoma skin cancer or in situ cancer of the cervix). c) Current or previous administration of tamoxifen or raioxifene or other SERMs for more than 3 months or participation in IBIS-I. d) Intention to continue with the use of estrogen-based hormone replacement therapy. e) Women who have had prophylactic mastectomy or are planning to perform this procedure. f) Evidence of osteoporosis or fragility fractures in the spine. However, these women could be chosen if they are prepared to receive treatment with bisphosphonates, having regular bone densitometry and ossification according to the sub-protocol group. g) Some severe concomitant illness that could in the opinion of the investigator, placing the woman at unusual risk or confusing the results of the study. h) Life expectancy <10 years or another medical condition that could mean interference with the ability to accept treatments chemo-preventive. i) Psychologically or physically not suitable for a therapy by 5 years of anti-estrogens. j) Treatment with non-approved or experimental drugs for 3 months prior to randomization.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical improvement and survival. Measure:Anastrozole is effective in the prevention of breast cancer in post-menopausal women at high risk of developing this disease. Timepoints:5 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:mortality Measure:Effect of Anastrozole on mortality in breast cancer. Timepoints:5 years | — |
Countries
Australia, New Zealand, United Kindgdom
Outcome results
None listed