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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.

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.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
REPEC
Registry ID
PER-068-03
Enrollment
3000
Registered
2004-01-22
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C50 Cancer de mama

Interventions

None listed

Sponsors

INTERNATIONAL BREAST CANCER STUDY GROUP - IBCSG
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: Postmenopausal patients. Patients with metastatic disease. Patients with breast cancer patients with definitive positive borders.

Design outcomes

Primary

MeasureTime frame
First confirmation of relapse, contralateral breast cancer, second primary tumor and / or death. NAME OF THE RESULT: 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). PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: 1 year—

Secondary

MeasureTime frame
First confirmation of relapse, contralateral breast cancer, second primary tumor and / or death. NAME OF THE RESULT: 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). PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: 1 year;First confirmation of relapse, contralateral breast cancer, second primary tumor and / or death. NAME OF THE RESULT: To compare the effect of Tamoxifen + Suppression of Ovarian Function versus exemestane + Suppression of Ovarian Function in cognitive function over 1 year. PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: 1 year—

Countries

Australia, Canada, Japan, United States

Outcome results

None listed

Source: REPEC (via WHO ICTRP) · Data processed: Apr 4, 2026