Trial Name: IBCSG-24-02
A Phase III Trial Evaluating the Role of Ovarian Function Suppression and the Role of Exemustane as Adjuvant Therapies for Premenopausal Women with Endocrine Responsive Breast Cancer
Trial Description:
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 tamoxifen alone in premenopausal women. It will also test whether a newer hormone drug called exemustane 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.
Treatment Plan:
Patients will be randomized to one of three treatment arms:
1. Tamoxifen
2. Tamoxifen plus ovarian suppression
3. Exemustane plus ovarian suppression
Patients:
- Premenopausal women with resected breast cancer with ER- and/or PR-positive tumors
- Must have estradiol level in premenopausal range after receiving chemotherapy
- No metastatic disease
- Lab tests, a current physical exam and medical history must meet study specific criteria
This is a brief overview of this clinical trial and only selected eligibility criteria are listed.
If you are interested in receiving more information to see if you are eligible to participate in this study, please contact:
Mercy General Hospital, Rhoda Pineda at (916) 453-4651, or e-mail rpineda@chw.edu
Mercy San Juan Medical Center, Margaret Murphy at (916) 537-5109, or e-mail margaret.murphy2@chw.edu