STUDY OF THE SUPPRESSION OF THE OVARIAN FUNCTION (SOFT), A PHASE III ASSAY EVALUATING THE ROLE OF THE SUPPRESSION OF THE OVARIAN FUNCTION AND THE ROLE OF THE EXEMESTANE AS ADJUVANT THERAPIES FOR PREMENOPAUSIC WOMEN WITH BREAST CANCER WITH ENDOCRINE RESPONSE.
Not Applicable
- Conditions
- -C50 Malignant neoplasm of breastMalignant neoplasm of breastC50
- Registration Number
- PER-068-03
- Lead Sponsor
- INTERNATIONAL BREAST CANCER STUDY GROUP - IBCSG,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Patient registered for the SOFT main study, but who have not yet started with the hormonal therapy protocol
Patient who have not yet received any adjuvant endocrine therapy
Patients who can speak and read fluently, the local language (s).
Written informed consent must be obtained.
Exclusion Criteria
Postmenopausal patients.
Patients with metastatic disease.
Patients with breast cancer
patients with definitive positive borders.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:First confirmation of relapse, contralateral breast cancer, second primary tumor and / or death.<br>Measure:Evaluate and compare changes in cognitive function over one year in postmenopausal patients with breast cancer, who receive adjuvant tamoxifen (T) with or without suppression of ovarian function (SFO).<br>Timepoints:1 year<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:First confirmation of relapse, contralateral breast cancer, second primary tumor and / or death.<br>Measure:To compare the effect of Tamoxifen + Suppression of Ovarian Function versus exemestane + Suppression of Ovarian Function in cognitive function over 1 year.<br>Timepoints:1 year<br>