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Protocol for Women at Increased Risk of Developing Breast Cancer

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ClinicalTrials.gov Identifier: NCT00291135
Recruitment Status : Completed
First Posted : February 13, 2006
Results First Posted : February 7, 2014
Last Update Posted : June 15, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: letrozole Phase 2

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : January 2003
Primary Completion Date : October 2008
Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Letrozole
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Oral Letrozole 2.5 mg daily for six months
Drug: letrozole
Letrozole 2.5 mg daily
Other Name: Femara


Outcome Measures

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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Medical Center
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
First Posted: February 13, 2006    Key Record Dates
Results First Posted: February 7, 2014
Last Update Posted: June 15, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Global results will be published.

Keywords provided by Carol Fabian, MD, University of Kansas Medical Center Research Institute:
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
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs