Phase 2 N=42 Prevention

Protocol for Women at Increased Risk of Developing Breast Cancer

Breast Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00291135 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2014

Primary outcome: Primary: Change in Proliferation of Breast Epithelial Cells Obtained by Random Periareolar Fine Needle Aspiration. — -2.3 Change in % of cells positive for Ki-67

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: letrozole (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Carol Fabian, MD
Primary completion: Oct 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Proliferation of Breast Epithelial Cells Obtained by Random Periareolar Fine Needle Aspiration.	-2.3	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00291135). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.