Letrozole With or Without Zoledronate in Treating Healthy Postmenopausal Women With High Breast Density

• Status: Completed
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may prevent breast cancer by lowering the amount of estrogen the body makes. Zoledronate may prevent bone loss caused by letrozole. Giving letrozole together with zoledronate may prevent breast cancer and reduce bone loss.

PURPOSE: This randomized clinical trial is studying letrozole and zoledronate to see how well they work compared to letrozole and placebo or placebo alone in treating healthy postmenopausal women with high breast density.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Virginia
• Collaborator: National Cancer Institute (NCI)
• Treatments: Diphosphonates; Letrozole; Zoledronic Acid

Criteria

DISEASE CHARACTERISTICS:

• Healthy participant

• Postmenopausal for > 5 years

• Breast density ≥ 50% by digitized mammography

• No history of breast cancer, breast implant, or gynecological malignancy

• No osteoporosis or postmenopausal fractures

• T-scores ≥ -2.0 by dual-energy x-ray absorptiometry (DEXA) scan

PATIENT CHARACTERISTICS:

Age

• 18 and over

Sex

• Female

Menopausal status

• See Disease Characteristics

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• AST or ALT ≤ 3 times normal

Renal

• Creatinine ≤ 1.5 mg/dL

Cardiovascular

• No cardiac disease

Other

• Nonsmoker

• Vitamin D ≥ 15 ng/mL

• No history of chronic medical or psychiatric condition or laboratory abnormality that would preclude study compliance or participation

• No alcohol consumption of > 2 alcoholic drinks per day

• No malabsorption

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• At least 1 year since prior hormone replacement therapy

• No concurrent steroids, parathyroid hormone, or raloxifene

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• No other concurrent medication known to affect calcium and bone metabolism (e.g., anticoagulants, antiseizure medications, bisphosphonates, or calcitonin)