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 enrollmentJuly 12, 2005

ConditionsPremenopausal women (estradiol (E2) levels in the premenopausal range) with histologically proven, resected breast cancer with ER and/or PgR positive tumors who have received either no chemotherapy or remain premenopausal following completion of adjuvant and/or neoadjuvant chemotherapy.MedDRA version: 14.0Level: PTClassification code 10057654Term: Breast cancer femaleSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]

DrugsNolvadex 20 mg tabletter Aromasin 25 mg dragerade tabletter Decaptyl LP 3.75 mg

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Premenopausal women (estradiol (E2) levels in the premenopausal range) with histologically proven, resected breast cancer with ER and/or PgR positive tumors who have received either no chemotherapy or remain premenopausal following completion of adjuvant and/or neoadjuvant chemotherapy.
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

July 12, 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 (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. 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; such patients should have 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. Premenopausal levels of serum estradiol may persist after chemotherapy\-induced amenorrhea despite prolonged amenorrhea. 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.
•Patients must have hormone receptor positive tumors. If there is more than one breast tumor, each tumor must be hormone receptor positive. Hormone receptors must be determined using immunohistochemistry. ER and/or PgR must be greater than or equal to 10% of the tumor cells positive by immunohistochemical evaluation. Biochemical determination alone is not acceptable.

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.
•Patients with previous or concomitant invasive malignancy EXCEPT adequately treated:
•\-basal or squamous cell carcinoma of the skin,