Protocol for Women at Increased Risk of Developing Breast Cancer

NCT00291135 — Phase 2, Completed, 42 participants, Carol Fabian, MD

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

Registry	NCT00291135
Status	Completed
Phase	Phase 2
Study type	Interventional; na, single group, masking: none, prevention
Enrollment	42 (Actual)
Sponsor	Carol Fabian, MD (Other); collaborators: Novartis
Conditions	Breast Cancer
Interventions	letrozole (Drug)
Dates	start 2003-01-01, primary completion 2008-10-01, completion 2008-10-01, first posted 2006-02-13, last updated 2016-06-15
Locations	1 site in United States

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
1	Experimental	Drug: letrozole	Oral Letrozole 2.5 mg daily for six months

letrozole (Drug), also known as Femara: Letrozole 2.5 mg daily

+Outcome measures

Primary outcomes

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

+Eligibility

Sex: Female, ages: 18 Years to any

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

+Posted results

Participant flow

Milestone	Letrozole
Started	42
Completed	42
Not completed	0

Outcome results

Change in Proliferation of Breast Epithelial Cells Obtained by Random Periareolar Fine Needle Aspiration. (Primary), Median, Change in % of cells positive for Ki-67: Letrozole -2.3 (-21.0 to 7.8)

Adverse events

Time frame: 6 months

Arm	Deaths	Serious adverse events	Other adverse events
Letrozole	0	0/42 (0.0%)	42/42 (100.0%)

Other adverse events by term

Term	Organ system	Letrozole
Arthralgia	Musculoskeletal and connective tissue disorders	21/42
Hot Flash	Reproductive system and breast disorders	26/42
Fatigue	General disorders	20/42
alopecia	Skin and subcutaneous tissue disorders	17/42

+Locations (1)

Facility	City	Country	Status
University of Kansas Medical Center	Kansas City, Kansas	United States

+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. PMID 19125322
Results publication: 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. doi: 10.1007/s10549-006-9476-5. Epub 2007 Jan 13. PMID 17221152
Results publication: 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. PMID 17484269

+Investigators

Carol J Fabian, MD, Principal investigator, University of Kansas Medical Center