Clinical Research Details
Title:
Phase III Trial of Evaluating the Role of Ovarian Function Suppression and the Role of Exemestane as Adjuvant Therapies for Premenopausal Women with Endocrine Responsive Breast Cancer
Purpose:
The purpose of this study is to determine the best hormonal treatment for premenopausal women. Patients are randomized to tamoxifen, tamoxifen plus ovarian suppression function (OFS) or exemestane plus OFS.
Study Number:
LU 106917
Number of Patients:
3000
Elgibility:
Participants must be premenopausal with a nestadiol level in the premenopausal range. Participants who did not receive chemotherapy should be randomized within 12 weeks after definitive surgery. Participants must have a histologically proven resected breast cancer. Participants also must have hormone receptor positive tumors and not have metastatic disease. Participants must have either an axillary dissection containing at least six nodes or a negative axillary sentinel node biopsy, and they must also have negative final margins.
Treatment:
Patients will be randomly assigned to one of three groups: tamoxifen; tamoxifen plus ovarian suppression; or exemestane plus ovarian suppression. Ovarian suppression may by accomplished by an injection of triptorelin once a month, surgery to remove the ovaries or radiation to destroy ovarian function. Treatment may continue for up to five years.
Principal Investigator:
Enrollment Phone:
(708) 327-3222