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In This Section Texas Health Research & Education Institute

Clinical Trials

Disease or Condition   Breast Cancer
Title   Suppression of Ovarian Function Plus Either Tamoxifen or Exemestane Compared With Tamoxifen Alone in Treating Premenopausal Women With Hormone-Responsive Breast Cancer
Description   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 clinical 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.
IRB Number   Pro244
Inclusion/Notes   INCLUSION:
  • Premenopausal women.

  • Histologically proven, resected breast cancer.

  • ER-positive or PgR-positive by IHC.

  • Patients may have received either no chemotherapy or remain premenopausal following completion of adjuvant and/or neoadjuvant chemotherapy.

  • The tumor must be confined to the breast and axillary nodes without detected metastases elsewhere, with the exception of tumor detected in internal mammary chain nodes by sentinel node procedures.

EXCLUSION:
  • Patients who have distant metastatic disease.

  • Patients who have locally advanced inoperable breast cancer including inflammatory breast cancer, supraclavicular node involvement, or enlarged internal mammary nodes (unless pathologically negative).

  • Patients who have clinically detectable residual axillary disease.

  • Patients who have had prior ipsilateral or contralateral invasive breast cancer.

  • Patients who have received endocrine therapy (including neoadjuvent and adjuvant) for more than 8 months after their breast cancer diagnosis.

  • Patients who have been on tamoxifen, hormone replacement therapy (HRT) or other SERMs within one year prior to diagnosis. Prior OCPs are allowed.
Status   Completed
Location   Texas Health Presbyterian Dallas
Principal Name    James Fredric Strauss MD
Contact Name   Lauren Braunfeld
Phone   (214) 345-2619

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