STUDY OF TAMOXIFEN AND EXEMESTANE MORE GNRH ANALOGUE AS ADJUVANT THERAPY FOR PREMENOPAUSIC WOMEN WITH BREAST CANCER WITH ENDOCRINE RESPONSE

Not Applicable

• Conditions: -C50 Malignant neoplasm of breast; Malignant neoplasm of breast; C50

• Registration Number: PER-069-03
• Lead Sponsor: INTERNATIONAL BREAST CANCER STUDY GROUP - IBCSG,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-01-26
• Last Update Posted: 20 August 2024

Recruitment & Eligibility

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

Inclusion Criteria

Premenopausal women [estradiol (E2) in premenopausal ranges (according to institutional parameters) after surgery] Patients should be randomized within 12 weeks of definitive surgery.

Exclusion Criteria

not contemplated

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:First confirmation of relapse (local, regional, or distant), contralateral breast cancer, second primary tumor (non-breast), and / or death.<br>Measure:Disease-free survival<br>Timepoints:1 ano<br>

Secondary Outcome Measures

Name	Time	Method
<br>Outcome name:Global survival (SG) is defined as the time from randomization to death from any cause.<br><br>Locations of first failure to treatment.<br>Late effects of early menopause.<br>Incidence of primary seconds (non-breast)<br>Causes of death without cancer event.<br>Measure:Global survival<br>Quality of life<br>Timepoints:1 year<br>