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. - Suppression of Ovarian Funktion Trial (SOFT)

International Breast Cancer Study Group (IBCSG)0 sites3,000 target enrollmentMay 2, 2005

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Histologically proven, resected breast cancer with ER and/or PgR positive tumors
Sponsor: International Breast Cancer Study Group (IBCSG)
Enrollment: 3000
Status: Active, not recruiting
Last Updated: 8 years ago

No summary available.

Registry

who.int

Start Date

May 2, 2005

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

International Breast Cancer Study Group (IBCSG)

•Premenopausal women \[estradiol (E2\) in the premenopausal range (according to
•institution parameters)] 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.
•Patients who received prior adjuvant and/or neoadjuvant chemotherapy should be
•randomized after completing chemotherapy and within 6 months of the final dose of
•chemotherapy as soon as premenopausal status is confirmed; such patients should have estradiol (E2\) in the premenopausal range between 2 weeks and 6 months after completing chemotherapy.
•Patients with temporary chemotherapy\-induced amenorrhea who regain premenopausal status within six months of the final dose of chemotherapy are eligible. \[Attention: under tamoxifen or aromatase inhibitors, even without evidence of menses, some women 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.
•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.
•Patients must have hormone receptor positive tumors. Hormone receptors must be

•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 bilateral invasive breast cancer.
•Patients with positive final margins (referring to only DCIS and invasive cancer, not
•Patients with clinically detectable residual axillary disease.
•Patients with a history of prior ipsilateral or contralateral invasive breast cancer.
•Patients with previous or concomitant malignancy EXCEPT adequately treated: basal or squamous cell carcinoma of the skin in situ carcinoma of the cervix or bladder,
•contra\- or ipsilateral in situ breast carcinoma.