Protocol for Women at Increased Risk of Developing Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Carol Fabian, MD, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT00291135
First received: February 10, 2006
Last updated: January 8, 2014
Last verified: January 2014
  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 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • Change in Proliferation of Breast Epithelial Cells Obtained by Random Periareolar Fine Needle Aspiration. [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
    Proliferation assessment by immunocytochemistry using Ki-67. Expressed as percent of cells staining positive for Ki-67.


Enrollment: 42
Study Start Date: January 2003
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Letrozole
Drug: letrozole
Letrozole 2.5 mg daily
Other Name: Femara

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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Carol Fabian, MD
Novartis
Investigators
Principal Investigator: Carol J Fabian, MD University of Kansas
  More Information

Publications:
Responsible Party: Carol Fabian, MD, Professor, Director Breast Cancer Prevention Unit, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT00291135     History of Changes
Other Study ID Numbers: 8884
Study First Received: February 10, 2006
Results First Received: June 24, 2013
Last Updated: January 8, 2014
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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Letrozole
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 20, 2014