Breast Cancer
Conditions
Keywords
breast atypia, open label pilot study, letrozole, fine needle aspiration, high risk for breast cancer, breast epithelial hyperplasia, Ki-67, hormones plus chemoprevention, chemoprevention
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.
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.
Interventions
DRUGletrozole
Letrozole 2.5 mg daily
Sponsors
Novartis
Carol Fabian, MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Proliferation of Breast Epithelial Cells Obtained by Random Periareolar Fine Needle Aspiration. | Baseline, 6 months | Proliferation assessment by immunocytochemistry using Ki-67. Expressed as percent of cells staining positive for Ki-67. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Letrozole Letrozole, 2.5 mg daily for six months | 42 |
| Total | 42 |
Baseline characteristics
| Characteristic | Letrozole |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 40 Participants |
| Age, Continuous | 50 years STANDARD_DEVIATION 7 |
| Region of Enrollment United States | 42 participants |
| Sex: Female, Male Female | 42 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 42 / 42 |
| serious Total, serious adverse events | 0 / 42 |
Outcome results
Primary
Change in Proliferation of Breast Epithelial Cells Obtained by Random Periareolar Fine Needle Aspiration.
Proliferation assessment by immunocytochemistry using Ki-67. Expressed as percent of cells staining positive for Ki-67.
Time frame: Baseline, 6 months
Population: All subjects completed study and were used for analysis
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Letrozole | Change in Proliferation of Breast Epithelial Cells Obtained by Random Periareolar Fine Needle Aspiration. | -2.3 Change in % of cells positive for Ki-67 |