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Evaluating the Effect of Letrozole With or Without Concomitant Zoledronic Acid on Estrogen Responsive Targets in Postmenopausal Women


N/A
18 Years
N/A
Not Enrolling
Female
Breast Cancer, Osteoporosis

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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 CenterCharlottesville, Virginia  22908