Study of Tamoxifen and Raloxifene (STAR) for the Prevention of Breast Cancer in Postmenopausal Women

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NSABP Foundation Inc
• Collaborators: AstraZeneca; Eli Lilly and Company; National Cancer Institute (NCI)
• Treatments: Raloxifene Hydrochloride; Tamoxifen

Criteria

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