A clinical trial to determine the efficacy of five years of Letrozole compared to placebo in patients completing five years of hormonal therapy consisting of an aromatase inhibitor (AI) or Tamoxifen followed by an AI in prolonging disease-free survival in postmenopausal women with hormone receptor positive breast cancer.

IBCSG 24-02 (SOFT)

Suppression of ovarian function plus either tamoxifen or exemestane compared with Tamoxifen alone in treating premenopausal women with hormone-responsive breast cancer

Principal Investigator:
James F. Strauss, M.D.

Co-Investigators:
Kristi J. McIntyre, M.D.
Haskell Kirkpatrick, M.D.
Minal Barve, M.D.
Lalan S. Wilfong, M.D.
Gabriel A. Shapiro, M.D.
Susan C. Guba, M.D.
Jivesh J. Sharma, M.D.
Kiran R. Kancharla, M.D.
Jaya V. Juturi, M.D.

Purpose:
Estrogen can stimulate the growth of breast tumor cells. Ovarian function suppression combined with hormone therapy using tamoxifen or exemestane may fight breast cancer by reducing the production of estrogen. It is not yet known whether suppression of ovarian function plus either tamoxifen or exemestane is more effective than tamoxifen alone in preventing the recurrence of hormone-responsive breast cancer. This randomized phase III trial is studying ovarian suppression with either tamoxifen or exemestane to see how well they work compared to tamoxifen alone in treating premenopausal women who have undergone surgery for hormone-responsive breast cancer. Patients will be randomly assigned to one of three treatment groups, and treatment will last for five years.

Eligibility (this is not a comprehensive list)

• No more than 8 months since chemotherapy
• No distant metastases
• Cancer in one breast only
• No previous breast cancer
• More than 1 year since hormone therapy (such as tamoxifen or raloxifene or hormone replacement therapy
• No more than 8 months of hormone therapy after receiving the diagnosis of breast cancer
• No previous radiation therapy to the ovaries
• No previous surgery to remove both ovaries

Final eligibility for a clinical trial is determined by the health professionals conducting the trial. For more details about the eligibility requirements for this trial please call 1-877-THR-WELL (1-877-847-9355).