NCT00003906
Study of Tamoxifen and Raloxifene (STAR) for the Prevention of Breast Cancer in Postmenopausal Women
PHASE3
COMPLETED
NCT00003906
INTERVENTIONAL
Study of Tamoxifen and Raloxifene (STAR) for the Prevention of Breast Cancer
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using raloxifene and tamoxifen may fight breast cancer by blocking the uptake of estrogen by the tumor cells.
PURPOSE: Randomized double-blinded clinical trial to compare the effectiveness of raloxifene with that of tamoxifen in preventing breast cancer in postmenopausal women.
DISEASE CHARACTERISTICS:
* Postmenopausal women at increased risk for developing invasive breast cancer, who meet one of the following criteria:
* At least 12 months since spontaneous menstrual bleeding
* Prior documented hysterectomy and bilateral salpingo-oophorectomy
* At least 55 years of age with prior hysterectomy with or without oophorectomy
* Age 35 to 54 with a prior hysterectomy without oophorectomy OR with a status of ovaries unknown with documented follicle-stimulating hormone level demonstrating elevation in postmenopausal range
* Histologically confirmed lobular carcinoma in situ treated by local excision only OR a minimum projected 5 year probability of invasive breast cancer of at least 1.66%, using Breast Cancer Risk Assessment Profile
* No clinical evidence of malignancy on physical exam within the past 180 days
* No evidence of suspicious or malignant disease on bilateral mammogram within the past year
* No bilateral or unilateral prophylactic mastectomy
* No prior invasive breast cancer or intraductal carcinoma in situ
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age:
* 35 and over
Sex:
* Female
Menopausal status:
* See Disease Characteristics
Performance status:
* No restricted normal activity for a significant portion of each day
Life expectancy:
* At least 10 years
Hematopoietic:
* Granulocyte count at least 1,500/mm\^3
* Complete blood count and differential normal
* Platelet count normal
Hepatic:
* SGOT or SGPT normal
* Bilirubin normal
* Alkaline phosphatase normal
Renal:
* Creatinine normal
Cardiovascular:
* No cerebral vascular accident, transient ischemic attack, atrial fibrillation, or uncontrolled hypertension
* No deep vein thrombosis
Pulmonary:
* No pulmonary embolus
Other:
* No other prior malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
* No concurrent nonmalignant disease that would preclude administration of tamoxifen or raloxifene
* No clinical depression, psychiatric condition, or addictive disorder
* No uncontrolled diabetes
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* Not specified
Endocrine therapy:
* At least 3 months since prior estrogen or progesterone replacement therapy, oral contraceptives, androgens, luteinizing hormone-releasing hormone analogs, prolactin inhibitors, or antiandrogens
* At least 3 months since prior tamoxifen, raloxifene, or other selective estrogen-receptor modulators of less than 3 months duration
* Concurrent Estring allowed
Radiotherapy:
* No prior breast radiotherapy
Surgery:
* See Disease Characteristics
Other:
* No prior systemic adjuvant therapy for breast cancer
* No other participation in a cancer prevention or osteoporosis prevention study involving pharmacologic intervention(s)
* NSABP-P-1 patients who received placebo are eligible
* No concurrent warfarin or cholestyramine
* Concurrent calcitonin or nonhormonal medication (e.g., cholecalciferol, fluoride, or bisphosphonates) allowed
Breast Cancer
- PREVENTION
-
- Type: DRUG
- Name: Raloxifene
- Description: 60 mg/day plus placebo for 5 years
- Arm Group Labels: Group 2
-
- Type: DRUG
- Name: Tamoxifen
- Description: 20 mg/day plus placebo for 5 years
- Arm Group Labels: Group 1
- NSABP Foundation Inc