Breast Cancer (SOFT) Study
IBCSG-24-02: 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 (SOFT)
Protocol ID
Protocol Description
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 (shutting down) the ovaries (which stops them from making hormones such as estrogen) helps prevent breast cancers from coming back in women who are premenopausal (women whose ovaries are still making hormones).
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. In addition the side effects of these different treatments will be studied.
Eligibility Criteria
Patients with breast cancer
Primary Investigator(s)
- Daniel Budman, MD