Evaluating the Effect of Letrozole With or Without Concomitant Zoledronic Acid on Estrogen Responsive Targets in Postmenopausal Women
18 Years
N/A
Female
Breast Cancer, Osteoporosis
Trial Information
Evaluating the Effect of Letrozole With or Without Concomitant Zoledronic Acid on Estrogen Responsive Targets in Postmenopausal Women
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
zoledronate.
- Compare the percent change in biochemical markers of bone turnover in participants
treated with these regimens.
Secondary
- Compare the bone density in participants treated with these regimens.
- Compare growth hormone release and insulin-like growth factor levels in participants
treated with these regimens.
- Compare the incidence and severity of adverse events in participants treated with these
regimens.
OUTLINE: This is a randomized, placebo-controlled, double-blind, multicenter, pilot study.
Participants are stratified according to prior hormone replacement therapy (HRT) use
(discontinued HRT > 5 years ago or no prior HRT use vs discontinued HRT 1-5 years ago).
Patients are randomized to 1 of 3 treatment arms.
- Arm I: Participants receive oral placebo once daily for 12 months and placebo IV over
15 minutes on day 0 and at 6 months.
- Arm II: Participants receive oral letrozole once daily for 12 months and placebo IV
over 15 minutes on day 0 and at 6 months.
- Arm III: Participants receive oral letrozole once daily for 12 months and zoledronate
IV over 15 minutes on day 0 and at 6 months.
In all arms, treatment continues in the absence of unacceptable toxicity.
After completion of study treatment, participants are followed at 3 months.
PROJECTED ACCRUAL: A total of 120 participants (40 per treatment arm) will be accrued for
this study.
Inclusion 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)
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention
Principal Investigator
Ailleen Heras-Herzig, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Virginia
Authority:
United States: Federal Government
Study ID:
CDR0000430927
NCT ID:
NCT00114270
Start Date:
May 2004
Completion Date:
June 2007
Related Keywords:
- Breast Cancer
- Osteoporosis
- breast cancer
- osteoporosis
- Breast Neoplasms
- Osteoporosis
Name | Location |
|---|---|
| University of Virginia Cancer Center | Charlottesville, Virginia 22908 |
