Protocol for Women at Increased Risk of Developing Breast Cancer - Full Text View

Sponsors and Collaborators:	University of Kansas Novartis
Information provided by:	University of Kansas
ClinicalTrials.gov Identifier:	NCT00291135

Purpose

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	Intervention	Phase
Breast Cancer	Drug: letrozole	Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Hormone Replacement Therapy

Drug Information available for: Letrozole

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Study of the Effect of Letrozole on Breast Biomarkers of High Risk Postmenopausal Women Receiving Hormone Replacement Therapy

Further study details as provided by University of Kansas:

Primary Outcome Measures:

Cytology of breast tissue aspirate using standard scoring methods and the Masood scoring system for proliferation markers. [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Baseline and twelve month analysis of serum markers for hormones and growth factors, as well as mammographic breast density at baseline and six months [ Time Frame: Baseline, 6 months, 12 months ] [ Designated as safety issue: No ]

Enrollment:	42
Study Start Date:	January 2003
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Letrozole	Drug: letrozole Letrozole 2.5 mg daily

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 EH/AH) and evidence of ER 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-PCR on breast specimens for aromatase expression will also be done at baseline.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00291135

Locations

United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160

Sponsors and Collaborators

University of Kansas

Novartis

Investigators

Principal Investigator:

Carol J Fabian, MD

University of Kansas

More Information

Responsible Party:	University of Kansas Medical Center ( Carol Fabian MD )
Study ID Numbers:	8884
Study First Received:	February 10, 2006
Last Updated:	September 15, 2008
ClinicalTrials.gov Identifier:	NCT00291135
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Kansas:

breast atypia
open label pilot study
letrozole
fine needle aspiration
high risk for breast cancer

breast epithelial hyperplasia
Ki-67
hormones plus chemoprevention
chemoprevention

Study placed in the following topic categories:

Hyperplasia
Skin Diseases
Breast Neoplasms
Letrozole
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

Therapeutic Uses
Enzyme Inhibitors
Aromatase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009