Study of Breast Cancer Prevention by Letrozole in High Risk Women

NCT00579826 | Completed Phase 2 Results DMC

• 3 other identifiers: 10587CFEM345AUS455R01CA122577-03
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Assessment of Change in Morphology by the Masood Score.

  Baseline to 6 Months

• Change in Mammographic Density From Baseline to 6 Months..

  Baseline to 6 Months

Other Outcomes (2)

• Change in Fibromyalgia Impact Questionnaire (FIQ) Score.

  Baseline to 6 months

• Change in Brief Fatigue Inventory (BFI) Score.

  baseline to 6 months

Study Arms (2)

Letrozole

EXPERIMENTAL

Letrozole, 2.5 mg daily for 6 months

Drug: Letrozole

Placebo

PLACEBO COMPARATOR

Placebo, daily for 6 months

Drug: Placebo

Interventions

Letrozole DRUG

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

Also known as: Letrozole(Femara)

Letrozole

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 30 Years - 69 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Carol Fabian, MD: lead
• Novartis: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Letrozole

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Bruce F. Kimler, Ph.D.
• Organization: University of Kansas Medical Center

bkimler@kumc.edu

913-588-4523

Study Officials

• Carol J Fabian, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Director Breast Cancer Prevention Unit

Study Record Dates

• First Submitted: December 18, 2007
• First Posted: December 24, 2007
• Study Start: October 1, 2006
• Primary Completion: March 1, 2015
• Study Completion: August 1, 2018
• Last Updated: June 12, 2023
• Results First Posted: February 23, 2017

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)