Phase 2
Completed N=42
Protocol for Women at Increased Risk of Developing Breast Cancer
Source: ClinicalTrials.gov NCT00291135 ↗Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Feb 2014
Primary outcomePrimary: Change in Proliferation of Breast Epithelial Cells Obtained by Random Periareolar Fine Needle Aspiration. — -2.3 Change in % of cells positive for Ki-67
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Proliferation of Breast Epithelial Cells Obtained by Random Periareolar Fine Needle Aspiration. |
-2.3 | — |
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
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. Informational only — not medical advice.