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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00114270
First received: June 13, 2005
Last updated: March 25, 2013
Last verified: April 2006
  Purpose

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.


Condition Intervention
Breast Cancer
Osteoporosis
Drug: letrozole
Drug: zoledronic acid

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Evaluating the Effect of Letrozole With or Without Concomitant Zoledronic Acid on Estrogen Responsive Targets in Postmenopausal Women

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: May 2004
Study Completion Date: June 2007
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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00114270

Locations
United States, Virginia
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
University of Virginia
Investigators
Principal Investigator: Ailleen Heras-Herzig, MD University of Virginia
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00114270     History of Changes
Other Study ID Numbers: CDR0000430927, UVACC-HIC-11019, UVACC-31003
Study First Received: June 13, 2005
Last Updated: March 25, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
breast cancer
osteoporosis

Additional relevant MeSH terms:
Breast Neoplasms
Osteoporosis
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Letrozole
Zoledronic acid
Diphosphonates
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Bone Density Conservation Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014