Protocol for Women at Increased Risk of Developing Breast Cancer

• ClinicalTrials.gov Identifier: NCT00291135
• Recruitment Status: Completed
• First Posted: February 13, 2006
• Results First Posted: February 7, 2014
• Last Update Posted: June 15, 2016
• Sponsor: Carol Fabian, MD
• Collaborator: Novartis
• Information provided by (Responsible Party): Carol Fabian, MD, University of Kansas Medical Center

Study Description

Brief Summary:

A pilot study to assess the effects of six months of letrozole on breast tissue risk markers in postmenopausal women on hormone replacement therapy at high risk of developing breast cancer.

Condition or disease	Intervention/treatment	Phase
Breast Cancer	Drug: letrozole	Phase 2

Detailed Description:

A pilot study of letrozole in postmenopausal women on hormone replacement therapy at high risk of developing breast cancer. Subjects will have hyperplasia with atypia (or borderline Epithelial Hyperplasia/Atypical Hyperplasia) and evidence of Estrogen Receptor expression by random periareolar fine needle aspiration and baseline serum estradiol levels less than or equal to 150 pg/ml. The feasibility of performing RT-qPCR on breast specimens for aromatase expression will also be done at baseline.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 42 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Study of the Effect of Letrozole on Breast Biomarkers of High Risk Postmenopausal Women Receiving Hormone Replacement Therapy
• Study Start Date: January 2003
• Actual Primary Completion Date: October 2008
• Actual Study Completion Date: October 2008

Arms and Interventions

Arm	Intervention/treatment
Experimental: 1; Oral Letrozole 2.5 mg daily for six months	Drug: letrozole; Letrozole 2.5 mg daily; Other Name: Femara

Outcome Measures

Primary Outcome Measures :

1. Change in Proliferation of Breast Epithelial Cells Obtained by Random Periareolar Fine Needle Aspiration. [ Time Frame: Baseline, 6 months ]
   Proliferation assessment by immunocytochemistry using Ki-67. Expressed as percent of cells staining positive for Ki-67.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• evidence of hyperplasia with/without atypia upon random periareolar fine needle aspiration of breast
• on hormone replacement therapy
• postmenopausal
• increased risk of developing breast cancer based on personal or family history
• never have taken aromatase inhibitors or selective estrogen receptor modulators in last six months
• women who have a high risk of breast cancer
• older than 18 years

Exclusion Criteria:

• anticoagulants
• marked breast tenderness
• pregnant or within twelve months of breast feeding/childbirth

Contacts and Locations

Locations

United States, Kansas

University of Kansas Medical Center

Kansas City, Kansas, United States, 66160

Sponsors and Collaborators

Carol Fabian, MD

Novartis

Investigators

• Principal Investigator: Carol J Fabian, MD; University of Kansas Medical Center

More Information

Publications of Results:

Fabian CJ, Kimler BF, Zalles CM, Khan QJ, Mayo MS, Phillips TA, Simonsen M, Metheny T, Petroff BK. Reduction in proliferation with six months of letrozole in women on hormone replacement therapy. Breast Cancer Res Treat. 2007 Nov;106(1):75-84. Epub 2007 Jan 13.

Bartels PH, Fabian CJ, Kimler BF, Ranger-Moore JR, Frank DH, Yozwiak ML, Alberts DS. Karyometry of breast epithelial cells acquired by random periareolar fine needle aspiration in women at high risk for breast cancer. Anal Quant Cytol Histol. 2007 Apr;29(2):63-70.

Other Publications:

Frank DH, Kimler BF, Fabian CJ, Ranger-Moore J, Yozwiak M, Bartels HG, Alberts DS, Bartels PH. Digital image analysis of breast epithelial cells collected by random periareolar fine-needle aspirates (RPFNA) from women at high risk for breast cancer taking hormone replacement and the aromatase inhibitor, letrozole, for six months. Breast Cancer Res Treat. 2009 Jun;115(3):661-8. doi: 10.1007/s10549-008-0274-0. Epub 2009 Jan 6.

• Responsible Party: Carol Fabian, MD, Professor, Director Breast Cancer Prevention Unit, University of Kansas Medical Center
• ClinicalTrials.gov Identifier: NCT00291135
• Other Study ID Numbers: 8884
• First Posted: February 13, 2006
• Results First Posted: February 7, 2014
• Last Update Posted: June 15, 2016
• Last Verified: May 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: Global results will be published.

Keywords provided by Carol Fabian, MD, University of Kansas Medical Center:

breast atypia; open label pilot study; letrozole; fine needle aspiration; high risk for breast cancer; breast epithelial hyperplasia; Ki-67; hormones plus chemoprevention; chemoprevention

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