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Breast Cancer

Suppression of Ovarian Function Plus Either Tamoxifen or Exemestane Compared With Tamoxifen Alone in Treating Premenopausal Women With Hormone-Responsive Breast Cancer 1

 

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.

Eligibility

Eligibility criteria include the following:

  • 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, please fill out MidMichigan's Clinical Trial Information Request Form (PDF, 35 KB), and the clinical trials nurse will contact you to determine your eligibility.

Treatment/Intervention

Patients will be randomly assigned to one of three groups:

  • Patients in group one will receive tamoxifen by mouth once a day.
  • Patients in group two will receive tamoxifen by mouth once a day. They will also undergo ovarian suppression by one of the following treatments:
    • An injection of triptorelin once a month.
    • Surgery to remove the ovaries.
    • Radiation therapy to the ovaries once a day for 4 or 5 days.
  • Patients in group three will receive exemestane by mouth once a day and ovarian suppression as in group two.
  • Treatment may continue for up to 5 years. Quality of life will be assessed periodically. After finishing treatment, patients will be evaluated periodically.

Clinical Trial Information Request Form (PDF, 35 KB)

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1 Protocol information provided courtesy of the National Cancer Institute, www.cancer.gov.

This page last updated November 15, 2006.