Protocol for Women at Increased Risk of Developing Breast Cancer

Breast Cancer Clinical Trial

Official title:

Study of the Effect of Letrozole on Breast Biomarkers of High Risk Postmenopausal Women Receiving Hormone Replacement Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00291135
• Other study ID #: 8884
• Status: Completed
• Phase: Phase 2
• First received: February 10, 2006
• Last updated: October 30, 2015
• Start date: January 2003
• Est. completion date: October 2008

Study information

• Verified date: October 2015
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• letrozole
Letrozole 2.5 mg daily

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Carol Fabian, MD	Novartis

Country where clinical trial is conducted

United States, 

References & Publications (3)

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( — View Citation

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 J — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Proliferation of Breast Epithelial Cells Obtained by Random Periareolar Fine Needle Aspiration.	Proliferation assessment by immunocytochemistry using Ki-67. Expressed as percent of cells staining positive for Ki-67.	Baseline, 6 months	No