INTERNATIONAL MULTICENTRIC STUDY OF TAMOXIFEN VS. ANASTROZOL IN WOMEN POST-MENOPAUSICAS WITH CARCINOMA DUCTAL IN SITU IBIS II (DCIS).

Phase 1

• Conditions: -D057 Other carcinoma in situ of breast; Other carcinoma in situ of breast; D057

• Registration Number: PER-040-03
• Lead Sponsor: ASTRAZENECA - PERU,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2003-08-06
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:It is the development of breast cancer confirmed histologically, both invasive and non-invasive (example, including new or recurrent DCIS).<br>Measure:Anastrozole is at least as effective as tamoxifen in local control and prevention of contralateral disease in women with locally resected DCIS.<br>Timepoints:6 month<br>

Secondary Outcome Measures

Name	Time	Method
<br>Outcome name:mortality<br>Measure:Effect of Tamoxifen vs Anastrozole on mortality from breast cancer.<br>Timepoints:6 month<br>