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Completed

NCT Number: 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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

30 year–69 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

letrozole

Drug

Letrozole 2.5 mg tablet daily. Then optional open label letrozole for another 6 months.

Other names: Letrozole(Femara)

Placebo

Drug

Placebo tablet daily for 6 months then optional open label letrozole for 6 months.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

    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.

  2. 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..

Other outcomes

  1. Change in Fibromyalgia Impact Questionnaire (FIQ) Score.

    Time frame: Baseline to 6 months

    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).

  2. Change in Brief Fatigue Inventory (BFI) Score.

    Time frame: baseline to 6 months

    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.

Sponsors and collaborators

Lead sponsor

Carol Fabian, MD

Other

Collaborators

  • National Cancer Institute (NCI)
  • Novartis

Registry information

Important dates

Study start
2006
Primary completion
2015
Study completion
2018
First posted
Dec 24, 2007
Registry last updated
Jun 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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