Copyright
2000 Michael Kan

These resources pages will provide additional information on various topics. Please use top menu to go to various pages

Resources on Medicine

STAR trial - Study of Tamoxifen And Raloxifene
NSABP Protocol P-2-study of tamoxifen and raloxifene for the prevention of breast cancer

This protocol is different from the P-1 protocol--risk factor of 1.66% or greater decides eligibility, regardless of age.
Call Scripps Breast Care Center for details (858)626-5200

Eligibility Criteria

1. Postmenopausal women, ages 35 and older, who are at increased risk for breast cancer.
2. Increased risk for breast cancer is defined as:
   * LCIS (lobular carcinoma in situ) treated by local excision only, or
   * At least a 1.66% projected 5-year probability of developing invasive breast cancer as determined by a STAR Risk Assessment Form.
3. Postmenopausal is defined as:
   * At least 12 months without spontaneous menstrual bleeding, OR
   * Prior hysterectomy and bilateral salpingo-oopherectomy, OR
   * Age = or > 55 with a prior hysterectomy ± oopherectomy, OR
   * Age < 55 with a prior hysterectomy without oopherectomy, with a FSH (follicle-stimulating hormone) level in the postmenopausal range.
4. Life expectancy of at least ten years.

Ineligibility Criteria

1. Prior invasive breast cancer; DCIS (ductal carcinoma in situ); or LCIS (lobular carcinoma in situ) treated with mastectomy, radiation, or systemic therapy.
2. Bilateral or unilateral prophylactic mastectomy.
3. Prior malignancy within 5 years (call Breast Care Center for exceptions)
4. History of DVT (deep venous thrombosis), PE (pulmonary embolus), CVA (cerebrovascular accident) or TIA (transient ischemic attack).
5. Current estrogen or progesterone replacement therapy, oral contraceptives, androgens/antiandrogens, prolactin inhibitors, or LHRH (luteinizing-hormone-releasing-hormone) analogs unless stopped at least 3 months before randomization. (Estring--estradiol vaginal rings is allowed)
6. Previous tamoxifen, raloxifene, or other SERM (selective estrogen receptor modulator) therapy, unless = or <  3 months duration.

Required Studies Prior to Randomization

1. History and physical examination within 180 days
2. Bimanual pelvic examination within 1 year
3. Bilateral mammogram within 1 year
4. CBC (complete blood counts), differential, platelets, alkaline phosphatase, SGOT (serum glutamic-oxaloacetic transaminase, liver enzyme) or SGPT (serum glutamic-pyruvic transaminase, liver enzyme), bilirubin, serum creatinine within 180 days
5. Blood for serum bank (5-8 ml, for research purposes).