| Title: | SOFT Trial |
| Purpose: | The purpose of this study is to see if shutting down a woman's ovaries plus giving tamoxifen is better at preventing the return of breast cancer than just giving tamoxifen alone in premenopausal women. It also will test whether a newer hormone drug called exemestane plus suppression of the ovaries is better than tamoxifen plus suppression of the ovaries. The side effects of these different treatments will be studied. |
| Study Number: | LU 106917 |
| Number of Patients: | 3000 |
| Elgibility: |
Participants must be premenopausal with stage I to stage III breast cancer that is estrogen- and progesterone-receptor positive.
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| 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: |
Kathy S. Albain, M.D. |
| Enrollment Phone: | (708) 327-3222 |
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