Study of Breast Cancer Prevention by Letrozole in High Risk Women

Breast Cancer Clinical Trial

Official title:

Study of Breast Cancer Prevention by Letrozole in High Risk Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00579826
• Other study ID #: 10587
• Secondary ID: CFEM345AUS455R01
• Status: Completed
• Phase: Phase 2
• Start date: October 2006
• Est. completion date: August 2018

Study information

• Verified date: May 2023
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: August 2018
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 69 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Letrozole
Letrozole 2.5 mg tablet daily. Then optional open label letrozole for another 6 months.
• Placebo
Placebo tablet daily for 6 months then optional open label letrozole for 6 months.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (3)

Lead Sponsor	Collaborator
Carol Fabian, MD	National Cancer Institute (NCI), Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Fibromyalgia Impact Questionnaire (FIQ) Score.	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
Other	Change in Brief Fatigue Inventory (BFI) Score.	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.	baseline to 6 months
Primary	Change in Proliferation Rate (Ki-67 by Immunocytochemistry) From 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
Secondary	Assessment of Change in Morphology by the Masood Score.	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
Secondary	Change in Mammographic Density From 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