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In This Section Texas Health Research & Education Institute

Clinical Trials

Disease or Condition   Breast Cancer
Title   STUDY OF TAMOXIFEN AND RALOXIFENE (STAR) FOR THE PREVENTION OF BREAST CANCER (Breast Cancer)
Description   This research is being done to find if raloxifene is effective in reducing the incidence of breast cancer in women who are at an increased risk for developing breast cancer.
IRB Number   Pro203
Inclusion/Notes   INCLUSION:
  • The participant must be as potmenopausal women. For the puroses of this trial, potmenopausal is defined as:
    a. A history of at least 12 months without spontaneous menstural bleeding.
    b. A prior hysterectomy and bilateral salpingo-oophorectomy.
    c. Age 55 years or older with a prior hysterectomy with or without oophorectomy.
    d. Age less than 55 years with a prior hysterectomy witnout oophorectomy or in whom the status of the ovaries in unknown, with a documented FSH level demonstratin confimatory elevation in the postmenopausal range.

  • The participant must consent to be in the study. The informed consent document must be signed, witnessed and dated prior to randomization.

  • The The participant must be 35 years of age or older at the time of the study entry, must be postmenopausal, and must have an increased risck for develpoing breast cancer. The participant must meet one of the following criteria that will be used to define increased risk for breast cancer:
    a. age equal to or greater than 35 years with a histologic diagnosis of lobualr carcinoma in situ (LCIS) treated by local excision only.
    b. a minimum projected 5 year probability of invasive breast cancer of at least 1.66%, as determined from the Breast Cancer Risk Assessment Profile generated by the NSABP Biostastitical Center.

  • The participant must have a life expetancy or at lest 10 years as judged by the investigator.

  • Within 180 days prior to randomization, the participant must have a general physical examination, including a breast examination demonstrating no clinical evidence of malignancy.

  • Within 365 days prior to randomization the participant must have a bilateral mammongaram that shows no evidence of suspicious or malignant disease, and a gynecologic exam, including a bimanual pelvic exam and if indicated, a pap smear ( refer to section 6.3 for execptions).

  • The participant's complete blood count (CBC), differential and platelet count must be obtained within 180 day s prior to randomization and these must be within limits judged by the investigator to be in keeping with standards of good medical care.

  • Participants with a previous history of benign neutropenia are eligible if the granulocyte count is greater than or equal to 1,500 cu mm.

  • There must be evidence of adequate hepatic function within 180 days prior to randomization (SGOT or SGPT, total bilirubin, alkaline phosphatase). The results must be within limits judged by the investigator to be in keping with standards of good medical care.

  • There must be evidence of adequate renal function within 180 days prior to randomization (serum creatinine). These results must be within limits judged by the ivestigator to be in keeping with standards of good medical care.

  • The participant may be receiving calcitonon or non-hormaonal medication, such as vitamin D, flouride, or bisphosphonates, to augment bone mineral density.

  • The participant must be accessible for follow up.

EXCLUSION:
  • Premenopasual status.

  • Less than 35 years of age.

  • Life expectancy of less than 10 years as judged by the investigator.

  • Prior or suspected invasive breast cancer of any type; intraductal carcinoma in stiu (DCIS); or previous lobular carcinoma in situ (LCIS) treated by mastectomy , radiation, or systemic adjuvant therapy.

  • Bilateral or unilateral prophylactic mastectomy.

  • Participation in any other cancer prevention study or osteoporosis prvention study involving pharacologic interventions. (NSABP Protocol P-1 participants who received placebo are eligible).

  • Prior malignancy of any type that occured less than 5 years previously, except basal or sqaumous cell carcinoma of the skin or carcinoma in situ of the cervix.

  • Exsisting non-malignant disease that would preclude the administration of tamoxifen or raloxifene.

  • Prior history of deep-vein thrombosis or pulmonary embolus.

  • Prior history of documented cerebral vascular accident or documented transient ischemic attack.

  • Performance staus that restricts noraml activity for a signifigant portion of each day.

  • Estrogen or progesterone replacement therapy; oral contraceptives; androgens [e.g., Danocrine(danazol)]; luteinizing-hormone-relasing (LHRH) analogs {e.g. Zoladex (grosereliin acetate) or Lupron (leuprolide acetate)]; prolctin inhibitors [e.g., Parlodel (bromocritine)]; or antiandrogens [e.g., Androcur (cryproterone acetate]. (women who discontinue these drugs at least 3 months prior to randomization will be eligible). However, partcipants using Estring (or similar product) may participate in the trial.

  • Psychiatric condition, including history of ciincal depression, or addictive disorder wich would preclude obtaining informed consent or would interfere with compliance.

  • Tamoxifen, raloxifene, or other SERM threapy (women wh, by self report, have received these therapies for less than 3 months duration and discontinue the drughs at least 3 month prior to randomization are eligible).

  • Current use of Coumadin or cholestyramine.

  • Uncontrolled hypertension ( The Joint NAtional Committee on the Prevention, Detection, Evaluation, and Treatment of Hypertension defines stage III hypertension as systolic blood pressure of 180 mm Hg or diastolic blood pressure of 110mm Hg based on the average of two ormore readings taken at each of two or more visits after an intial screeing).

  • Incontrolled diabetes. (This is defined as a HbA1C test result of greater than 9%, which roughly equates to a fasting glucose of 200mg%).

  • Atiral fibrillation.
Status   Completed
Location   Texas Health Presbyterian Hospital Dallas
Principal Name    James Fredric Strauss MD
Contact Name   Shelley Long
Phone   (214) 345-8131

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