- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00579826
Study of Breast Cancer Prevention by Letrozole in High Risk Women
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.
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
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Kansas
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Kansas City, Kansas, United States, 66160
- University of Kansas Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Post-menopausal women at high risk for development of breast cancer
- 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-hydroxyvitamin 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Letrozole
Letrozole, 2.5 mg daily for 6 months
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Letrozole 2.5 mg tablet daily.
Then optional open label letrozole for another 6 months.
Other Names:
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Placebo Comparator: Placebo
Placebo, daily for 6 months
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Placebo tablet daily for 6 months then optional open label letrozole for 6 months.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 (RPFNA) from women at high risk for the development of breast cancer.
|
Baseline to 6 Months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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..
|
Baseline to 6 Months
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Assessment of Change in Morphology by the Masood Score.
Time Frame: Baseline to 6 Months
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Masood score is a semi-quantitative index of increasing abnormality, thus higher values are worse. Range 6 to 24. Based on Masood S, Frykberg ER, McLellan GL, Scalapino MC, Mitchum DG, Bullard JB. Prospective evaluation of radiologically directed fine-needle aspiration biopsy of nonpalpable breast lesions. Cancer 1990; 66:1480-7. |
Baseline to 6 Months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Fibromyalgia Impact Questionnaire (FIQ) Score.
Time Frame: Baseline to 6 months
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Assessment of impact of fibromyalgia on everyday living activities.
Composite score ranges from 0 (best, no interference or impact on activities) to 104 (worst, maximum interference with activities).
|
Baseline to 6 months
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Change in Brief Fatigue Inventory (BFI) Score.
Time Frame: baseline to 6 months
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Assessment of the extent to which fatigue interferes in normal everyday living activities.
Change over 6 months of treatment is assessed.
Range from 0 (best, no fatigue) to 10 (worst).
Increase in score indicates greater intensity of fatigue and/or greater interference with activities due to fatigue.
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baseline to 6 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Carol J Fabian, MD, University of Kansas Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Hormone Antagonists
- Aromatase Inhibitors
- Steroid Synthesis Inhibitors
- Estrogen Antagonists
- Letrozole
Other Study ID Numbers
- 10587
- CFEM345AUS45 (Other Grant/Funding Number: Novartis)
- 5R01CA122577-03 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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