Protocol for Women at Increased Risk of Developing Breast Cancer
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | January 2003 |
| End Date: | October 2008 |
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.
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.
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.
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
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