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Protocol for Women at Increased Risk of Developing Breast Cancer

Primary Purpose

Breast Cancer

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

letrozole

About this trial

This is an interventional prevention trial for Breast Cancer focused on measuring breast atypia, open label pilot study, letrozole, fine needle aspiration, high risk for breast cancer, breast epithelial hyperplasia, Ki-67, hormones plus chemoprevention, chemoprevention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

University of Kansas Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Oral Letrozole 2.5 mg daily for six months

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00291135

First Posted

February 10, 2006

Last Updated

May 11, 2016

Sponsor

Carol Fabian, MD

Collaborators

Novartis

1. Study Identification

Unique Protocol Identification Number

NCT00291135

Brief Title

Protocol for Women at Increased Risk of Developing Breast Cancer

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2016

Overall Recruitment Status

Completed

Study Start Date

January 2003 (undefined)

Primary Completion Date

October 2008 (Actual)

Study Completion Date

October 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Carol Fabian, MD

Collaborators

Novartis

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

42 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Oral Letrozole 2.5 mg daily for six months

Intervention Type

Drug

Intervention Name(s)

letrozole

Other Intervention Name(s)

Femara

Intervention Description

Letrozole 2.5 mg daily

Primary Outcome Measure Information:

Title

Change in Proliferation of Breast Epithelial Cells Obtained by Random Periareolar Fine Needle Aspiration.

Description

Proliferation assessment by immunocytochemistry using Ki-67. Expressed as percent of cells staining positive for Ki-67.

Time Frame

Baseline, 6 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Carol J Fabian, MD

Organizational Affiliation

University of Kansas Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Kansas Medical Center

City

Kansas City

State/Province

Kansas

ZIP/Postal Code

66160

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Global results will be published.

Citations:

PubMed Identifier

19125322

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.

Results Reference

background

PubMed Identifier

17221152

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. doi: 10.1007/s10549-006-9476-5. Epub 2007 Jan 13.

Results Reference

result

PubMed Identifier

17484269

Citation

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.

Results Reference

result

Learn more about this trial

Protocol for Women at Increased Risk of Developing Breast Cancer

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