Clinical Trials

Suppression of Ovarian Function Trial (SOFT):

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

Treatment with hormones has been shown to help prevent breast cancers from coming back after they have been removed by surgery if the breast cancer has hormone receptors. The hormone generally used is tamoxifen, and it is usually given for five years. It has also been shown that suppressing the ovaries (which stops them from making hormones such as estrogen) helps prevent breast cancers from coming back in women who are premenopausal. This study is being done to see if shutting down the ovaries plus giving tamoxifen is better at preventing the return of breast cancer than just giving tamoxifen alone in premenopausal women. It will also test whether a newer hormone drug called exemestane plus suppression of the ovaries is better than tamoxifen plus suppression of the ovaries.

Patient Population:
Premenopausal women who meet the following criteria:
  • Patients who did not receive chemotherapy should be randomized within 12 weeks after definitive 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;
  • Patients with temporary chemotherapy-induced amenorrhea who regain premenopausal status within six months of the final dose of chemotherapy.

Must have hormone receptor positive tumors.

The tumor must be confined to the breast and axillary nodes without detectable metastases elsewhere.

 
Patients will be randomized to one of the following:
  • Arm A will receive tamoxifen for five years at a dose of 20 mg per day. Tamoxifen is a pill that is taken by mouth each day.
  • Arm B will receive tamoxifen for five years plus ovarian suppression for five years.
  • Arm C will receive exemestane for five years plus ovarian suppression for five years. Exemestane is a pill that is taken by mouth each day.

Exemestane will be provided free of charge.

For more information or to have a patient screened, contact the SOFT Study Coordinator at 713-798-1986.