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Study of Breast Cancer Prevention by Letrozole in High Risk Women

This study is currently recruiting participants.
Verified April 2013 by University of Kansas
Sponsor:
Collaborators:
Novartis
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Carol Fabian, MD, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT00579826
First received: December 18, 2007
Last updated: April 11, 2013
Last verified: April 2013
History of Changes
  Purpose

This is a multi-institution double-blind placebo-controlled trial whose main objective is to determine if 6 months of letrozole (2.5 mg daily) can reduce proliferation as assessed by Ki-67 in high risk postmenopausal women on systemic hormone replacement therapy who have random periareolar fine needle aspiration (RPFNA) evidence of hyperplasia with atypia or borderline atypia, and a minimum Ki-67 of >1.5%.

The primary hypothesis is that proliferation and expression of other estrogen response genes will be favorably modulated by six months of letrozole relative to placebo without substantially increasing hot flashes or worsening overall quality of life.


Condition Intervention Phase
Breast Cancer
 Drug: Letrozole
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Study of Breast Cancer Prevention by Letrozole in High Risk Women

Resource links provided by NLM:

Drug Information available for: Letrozole
U.S. FDA Resources

Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • Assessment of proliferation rate (Ki-67 by immunocytochemistry) in benign breast epithelial cells acquired by random periareolar fine needle aspiration from women at high risk for the development of breast cancer. [ Time Frame: 6 Month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assessment of change in morphology by nuclear morphometry and the semi-quantitative Masood score index and change in qRT-PCR assessed estrogen response genes. [ Time Frame: 6 Months, 12 Months ] [ Designated as safety issue: No ]
  • Mammographic density and bioavialable estradiol and testosterone will be assessed as well. [ Time Frame: 6 Months, 12 Months ] [ Designated as safety issue: No ]
  • Change in biomarkers associated with bone and cardiovascular health, adverse events, BCPT Symptom Check List, hot flash score, general fatigue inventory, the Fibromyalgia Impact Questionnaire. [ Time Frame: 6 Months, 12 Months ] [ Designated as safety issue: No ]
  • 25-OH vitamin D levels will be assessed. [ Time Frame: Baseline and 6 month 2 ] [ Designated as safety issue: No ]

Estimated Enrollment: 108
Study Start Date: October 2006
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Letrozole, 2.5 mg daily for 6 months
 Drug: Letrozole
Letrozole 2.5 mg tablet daily. Then optional open label letrozole for another 6 months.
Other Name: Letrozole(Femara)
Placebo Comparator: 2
Placebo, daily for 6 months
 Drug: Placebo
Placebo tablet daily for 6 months then optional open label letrozole for 6 months.

Detailed Description:

Subsequent to the 6 month RPFNA for assessment of biomarkers, toxicity and quality of life assessments, all women may receive optional open-label letrozole for an additional 6 months, followed by a third RPFNA and biomarker

  Eligibility

Ages Eligible for Study:   30 Years to 69 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Post-menopausal women at high risk for development of breast cancer
  • On a stable dose of hormone replacement therapy
  • have cytomophologic evidence of hyperplasia +/- atypia and Ki-67 expression >1.5% in benign breast epithelial cells acquired by RPFNA
  • Serum level of 25-OH vitamin D of at least 30 ng/ml prior to study entry
  • Willing to have a repeat RPFNA and mammogram at 6 months and 12 months (if participating in the open label portion of the study) following initiation of study drug

Exclusion Criteria:

  • Prior history of osteoporosis or osteoporotic fracture.
  • Prior history of invasive breast cancer or other invasive cancer within five years from date of study entry.
  • Current and chronic use of COX-2 specific inhibitors or NSAIDs
  • Receiving treatment for rheumatoid arthritis or fibromyalgia
  • Current history of poorly controlled migraines or perimenopausal symptoms
  • Currently receiving other investigational agents.
  • Receipt of more than 6 months of an aromatase inhibitor (anastrozole, exemestane, letrozole, etc.) at any time in the past.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00579826

Locations
United States, California
University of California San Francisco Active, not recruiting
San Francisco, California, United States, 94115
United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Bruce F Kimler, Ph.D.     913-588-4523     bkimler@kumc.edu    
Principal Investigator: Carol Fabian, MD            
Sponsors and Collaborators
Carol Fabian, MD
Novartis
National Cancer Institute (NCI)
Investigators
Principal Investigator: Carol J Fabian, MD University of Kansas
  More Information

No publications provided

Responsible Party: Carol Fabian, MD, Professor, Director Breast Cancer Prevention Unit, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT00579826     History of Changes
Other Study ID Numbers: 10587, CFEM345AUS45, 5R01CA122577-03
Study First Received: December 18, 2007
Last Updated: April 11, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Letrozole
 Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013