None listed
Conditions
Interventions
Anastrozole Type of group
Anastrozole 1 mg + Tamoxifen placebo will be administered
Group name:Tamoxifen Type of group
Tamoxifen 20 mg + Anastrozole placebo will be administered.
Sponsors
ASTRAZENECA - PERU,
Eligibility
Inclusion criteria
Inclusion criteria: a) All women must be post-menopausal and have between 40 to 70 years. The post-menopausal state is defined as 1 or more of the following criteria: Greater than 60 years, bilateral Ortectomy, less than 60 years with uterus and amenorrhea of at least 12 months, less than 60 years without uterus and with FSH> 20 Ul / L. b) CDIS locally resected within the last 6 months. c) Having baseline bone densitometry within the last 2 years will be required in all women. A column radiograph to rule out Frailty fractures will also be required.
Exclusion criteria
Exclusion criteria: a) Pre-menopausal woman. b) Any previous cancer in the last 5 years (except non-melanoma skin cancer or in situ cancer of the cervix). c) Current treatment with anticoagulants. d) Deep vein thrombosis or previous puimonar embolism. e) Transient ischemic cerebral accident (TIA) or previous cerebrovascular accident. f) Current or previous administration of Tamoxifen or Raloxifene or other SERMs for more than 3 months or participation in IBIS-I. g) Intention to continue with the use of hormone replacement therapy based on estrogens. h) Women who have had a prophylactic mastectomy or are planning to perform this procedure. i) Any woman with post-menopausal bleeding not explained.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:It is the development of breast cancer confirmed histologically, both invasive and non-invasive (example, including new or recurrent DCIS). Measure:Anastrozole is at least as effective as tamoxifen in local control and prevention of contralateral disease in women with locally resected DCIS. Timepoints:6 month | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:mortality Measure:Effect of Tamoxifen vs Anastrozole on mortality from breast cancer. Timepoints:6 month | — |
Countries
Australia, Belgium, Brazil, Denmark, Finland, Germany, Italy, Netherlands, Sweden, Switzerland, United Kindgdom
Outcome results
None listed