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In This Section Texas Health Research & Education Institute

Clinical Trials

Disease or Condition   Breast Cancer
Title   Letrozole in Treating Postmenopausal Women Who Have Received Hormone Therapy for Hormone Receptor-Positive Breast Cancer
Description   The purpose of this study is to compare ovarian function suppression (by triptorelin, oophorectomy, or ovarian irradiation) in combination with tamoxifen vs. tamoxifen alone; exemestane vs. tamoxifen alone; and exemestane vs. ovarian function suppression in patients with endocrine-responsive breast cancer. Patients are randomized to 1 of 3 treatment arms:
Arm I: Patients receive oral tamoxifen daily.
Arm II: Patients receive tamoxifen as in arm I and ovarian function suppression by 1 of the following treatments:
-Triptorelin intramuscularly once every 28 days
-Surgical oophorectomy
-Ovarian irradiation once daily for 4 or 5 days
Arm III: Patients receive oral exemestane daily and ovarian function suppression as in arm II.
Treatment continues for 5 years in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed periodically.
IRB Number   Pro219
Inclusion/Notes   INCLUSION:
  • Premenopausal women.

  • Histologically proven, resected breast cancer.

  • ER-positive or PgR-positive by IHC.

  • Patients who did not receive chemotherapy should be randomized with 12 weeks after definitive surgery; such patients should have estradiol (E2) in the premenopausal range following surgery.

  • Patients who received prior adjuvant and/or neoadjuvant chemotherapy should be randomized after completing chemotherapy and within 6 months of the final dose of chemotherapy as soon as premenopausal status is confirmed; such patients should have estradiol (E2) in the premenopausal range between 2 weeks and 6 months after completing chemotherapy.

EXCLUSION:
  • Patients pregnant or nursing.

  • Patients with a history of noncompliance to medical regimens.

  • Patients with other nonmalignant systemic disease that would preclude prolonged follow-up.

  • Patients with prior or concurrent invasive malignancy except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix or bladder, contralateral or ipsilateral carcinoma in situ of the breast, or nonbreast invasive malignancy diagnosed at least 5 years ago without recurrence.
Status   Active - not Recruiting
Location   Texas Health Presbyterian Dallas
Principal Name    Haskell McGill Kirkpatrick MD
Contact Name   Lauren Braunfeld
Phone   (214) 345-2619

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