Status:
COMPLETED
Letrozole With or Without Zoledronate in Treating Healthy Postmenopausal Women With High Breast Density
Lead Sponsor:
University of Virginia
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Osteoporosis
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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 p...
Detailed Description
OBJECTIVES: Primary * Compare the percent change in breast density in healthy postmenopausal women with high breast density treated with placebo only vs letrozole and placebo vs letrozole and zoledr...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
End Date :
June 1 2007
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00114270
Start Date
May 1 2004
End Date
June 1 2007
Last Update
March 26 2013
Active Locations (1)
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1
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22908