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

February 10, 2006
January 8, 2014
January 2003
October 2008   (final data collection date for primary outcome measure)
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.
Cytology of breast tissue aspirate using standard scoring methods and the Masood scoring system for proliferation markers.
Complete list of historical versions of study NCT00291135 on ClinicalTrials.gov Archive Site
Not Provided
Baseline and twelve month analysis of serum markers for hormones and growth factors, as well as mammographic breast density at baseline and six
Not Provided
Not Provided
 
Protocol for Women at Increased Risk of Developing Breast Cancer
Study of the Effect of Letrozole on Breast Biomarkers of High Risk Postmenopausal Women Receiving Hormone Replacement Therapy

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.

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Breast Cancer
Drug: letrozole
Letrozole 2.5 mg daily
Other Name: Femara
Experimental: 1
Letrozole
Intervention: Drug: letrozole

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
October 2008
October 2008   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00291135
8884
No
Carol Fabian, MD, University of Kansas Medical Center Research Institute
Carol Fabian, MD
Novartis
Principal Investigator: Carol J Fabian, MD University of Kansas
University of Kansas
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP