This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Study of Breast Cancer Prevention by Letrozole in High Risk Women

This study has been completed.
Sponsor:
Collaborators:
Novartis
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Carol Fabian, MD, University of Kansas Medical Center
ClinicalTrials.gov Identifier:
NCT00579826
First received: December 18, 2007
Last updated: January 4, 2017
Last verified: January 2017
  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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Study of Breast Cancer Prevention by Letrozole in High Risk Women

Resource links provided by NLM:


Further study details as provided by Carol Fabian, MD, University of Kansas Medical Center:

Primary Outcome Measures:
  • Change in Proliferation Rate (Ki-67 by Immunocytochemistry) From Baseline to 6 Months [ Time Frame: Baseline to 6 Months ]
    Change in proliferation rate (percent positively stained cells for Ki-67 antigen 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.


Secondary Outcome Measures:
  • Assessment of Change in Morphology by the Masood Score. [ Time Frame: Baseline to 6 Months ]
    Masood score is a semi-quantitative index of increasing abnormality, thus higher values are worse. Range 6 to 24.

  • Change in Mammographic Density From Baseline to 6 Months.. [ Time Frame: Baseline to 6 Months ]
    Percent area of the breast considered to be at increased density, as determined by the computer program Cumulus..

  • Change in Biomarkers Associated With Bone and Cardiovascular Health, Adverse Events, Breast Cancer Prevention Trial (BCPT) Symptom Check List, Hot Flash Score, General Fatigue Inventory, the Fibromyalgia Impact Questionnaire. [ Time Frame: 6 Months, 12 Months ]

Enrollment: 55
Study Start Date: October 2006
Study Completion Date: March 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Letrozole
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: Placebo
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   (Adult, Senior)
Sexes 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 cytomorphologic 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 random periareolar fine needle aspiration (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 cyclooxygenase-2 (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
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: NCT00579826

Locations
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
Carol Fabian, MD
Novartis
National Cancer Institute (NCI)
Investigators
Principal Investigator: Carol J Fabian, MD University of Kansas Medical Center
  More Information

Responsible Party: Carol Fabian, MD, Professor, Director Breast Cancer Prevention Unit, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT00579826     History of Changes
Other Study ID Numbers: 10587
CFEM345AUS45 ( Other Grant/Funding Number: Novartis )
5R01CA122577-03 ( US NIH Grant/Contract Award Number )
Study First Received: December 18, 2007
Results First Received: July 19, 2016
Last Updated: January 4, 2017
Individual Participant Data  
Plan to Share IPD: No
Plan Description: Global results will be published.

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Letrozole
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 26, 2017