A phase III trial evaluating the role of ovarian function suppression and the role of exemestane as adjuvant therapies for premenopausal women with endocrine responsive breast cancer.Ensayo en fase III para evaluar el papel de la supresión de la función ovárica y el papel de exemestano como tratamientos adyuvantes para mujeres premenopáusicas con cáncer de mama endocrino sensible. - Suppression of Ovarian Funktion Trial (SOFT)

International Breast Cancer Study Group (IBCSG)0 sites3,000 target enrollmentNovember 28, 2005

DrugsTamoxifeno FUNK 20mg Aromasil 25 mg Decapeptyl L.P. 3.75 mg

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: International Breast Cancer Study Group (IBCSG)
Enrollment: 3000
Status: Active, not recruiting
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

November 28, 2005

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Investigators

Sponsor

International Breast Cancer Study Group (IBCSG)

Eligibility Criteria

Inclusion Criteria

•Premenopausal women \[estradiol (E2\) in the premenopausal range] who meet the following criteria:
•Patients who did not receive chemotherapy should be randomized within 12 weeks after definitive surgery. Such patients should have estradiol (E2\) in the premenopausal range following surgery; the only patients who do not require testing of estradiol (E2\) to confirm premenopausal status are those who have been menstruating regularly during the 6 months prior to randomization and have not used any form of hormonal contraception or any other hormonal treatments during the 6 months prior to randomization.
•Patients who received prior adjuvant and/or neoadjuvant chemotherapy should be
•randomized after completing chemotherapy and within 8 months of the final dose of
•chemotherapy as soon as premenopausal status is confirmed; all such patients should have premenopausal status confirmed by an estradiol (E2\) in the premenopausal range between 2 weeks and 8 months after completing chemotherapy.
•Adjuvant trastuzumab (Herceptin ®) is allowable, and is not considered to be chemotherapy for eligibility timing determination.
•Patients with temporary chemotherapy\-induced amenorrhea who regain premenopausal status within eight months of the final dose of chemotherapy are eligible. \[Please note that some patients taking tamoxifen or aromatase inhibitors, even without evidence of menses, may have ovarian function recovery following chemotherapy and resume estradiol secretion.] Premenopausal levels of serum estradiol may persist after chemotherapy\-induced amenorrhea despite prolonged amenorrhea \[34]. Therefore in patients wishing to participate in the study, with postmenopausal hormone levels shortly after chemotherapy, it is recommended to
•recheck their estradiol level at a later timepoint within 8 months of completing
•chemotherapy, even in the absence of return of menses.
•Histologically proven, resected breast cancer. Pathology material should be available for submission for central review as part of the quality control measures for this protocol.

Exclusion Criteria

•Patients who are postmenopausal (i.e., do not have an estradiol (E2\) level in the
•premenopausal range) after surgery or after chemotherapy, whichever is later.
•Patients with distant metastatic disease.
•Patients with locally advanced inoperable breast cancer including inflammatory breast
•cancer or supraclavicular node involvement or with enlarged internal mammary nodes (unless pathologically negative) are not eligible. Patients with involved internal mammary nodes detected by sentinel node biopsy that are not enlarged are eligible.
•Patients with positive final margins (referring to only DCIS and invasive cancer, not
•LCIS), except as noted in section 3\.1\.5\. DCIS at a margin is permitted if a complete mastectomy has been performed.
•Patients with clinically detectable residual axillary disease.
•Patients with a history of prior ipsilateral or contralateral invasive breast cancer. Patients with synchronous bilateral invasive breast cancer (diagnosed histologically within 2 months) are eligible if the bilateral disease meets all other eligibility criteria (see section 8\.1\.2 for data management for such patients).
•Patients with previous or concomitant invasive malignancy are not eligible. The