In This SectionTexas Health Research & Education Institute
Disease or Condition
Study of Tamoxifen and Raloxifene (STAR) for the Prevention of Breast Cancer (Breast Cancer)
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.
The participant must be a postmenopausal woman. For the purposes of this trial, postmenopausal is defined as:
1. A history of at least 12 months without spontaneous menstrual bleeding, or
2. A prior documented hysterectomy and bilateral salpingo-oophorectomy, or
3. age 55 years or older with a prior hysterectomy with or without oophorectomy, or
4. age < 55 years with a prior hysterectomy without oophorectomy or in whom the status of the ovaries is unknown, with a documented FSH level demonstrating confirmatory 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 participant must be 35 years of age or older at the time of study entry, must be postmenopausal, and must have an increased risk for developing breast cancer.
The participant must meet one of the following criteria that will be used to define increased risk for breast cancer.
Age = 35 years with a histologic diagnosis of lobular carcinoma in situ (LCIS) treated by local excision only; or
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 Biostatistical Center.
The participant must have a life expectancy of at least 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 mammogram 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 exceptions).
The participant’s complete blood count (CBC), differential, and platelet count must be obtained within 180 days 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 = 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 keeping with standards of good medical care.
There must be evidence of adequate renal function within 180 days prior to randomization (serum creatinine).
The participant may be receiving calcitonin or non-hormonal medications, such as vitamin D, fluoride, or bisphosphonates, to augment bone mineral density.
The participant must be accessible for follow up.
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 situ (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 prevention study involving pharmacologic intervention(s). (NSABP Protocol P-1 participants who received placebo are eligible.)
Prior malignancy of any type that occurred less than 5 years previously, except basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
Existing 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 status that restricts normal activity for a significant portion of each day.
Estrogen or progesterone replacement therapy; oral contraceptives; androgens [e.g., Danocrine® (danazol)]; luteinizing-hormone-releasing-hormone (LHRH) analogs [e.g., Zoladex® (goserelin acetate) or Lupron® (leuprolide acetate)]; prolactin inhibitors [e.g., Parlodel® (bromocriptine)]; or antiandrogens [e.g., Androcur® (cyproterone acetate)]. (Women who discontinue these drugs at least 3 months prior to randomization will be eligible.) However, participants using Estring® (or a similar product) may participate in the trial.
Psychiatric condition, including history of clinical depression, or addictive disorder which would preclude obtaining informed consent or would interfere with compliance.
Tamoxifen, raloxifene, or other SERM therapy (women who, by self report, have received these therapies for less than 3 months duration and discontinue the drugs at least 3 months 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 a systolic blood pressure of 180 mm Hg or a diastolic blood pressure of 110 mm Hg based on the average of two or more readings taken at each of two or more visits after an initial screening.)
Uncontrolled diabetes. (This is defined as a HbA1C test result > 9%, which roughly equates to a fasting glucose of 200 mg%.)