A Phase 2 interventional study of letrozole in Breast Cancer, sponsored by Carol Fabian, MD. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-06-15.
Sponsored by Carol Fabian, MD · Phase 2, Interventional, and Prevention
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 42 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Carol Fabian, MD is the lead sponsor of 16 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Oral Letrozole 2.5 mg daily for six months
Drug: letrozole
Letrozole 2.5 mg daily
Also known as: Femara
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
| Milestone | Letrozole |
|---|---|
| Started | 42 |
| Completed | 42 |
| Not completed | 0 |
Proliferation assessment by immunocytochemistry using Ki-67. Expressed as percent of cells staining positive for Ki-67.
| Change in % of cells positive for Ki-67 | Letrozole |
|---|---|
| Change in Proliferation of Breast Epithelial Cells Obtained by Random Periareolar Fine Needle Aspiration. | -2.3 (-21.0 to 7.8) |
Collected over 6 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Letrozole | — | 0/42 (0%) | 42/42 (100%) |
| Event | Letrozole |
|---|---|
| Hot FlashReproductive system and breast disorders | 26/42 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 21/42 |
| FatigueGeneral disorders | 20/42 |
| alopeciaSkin and subcutaneous tissue disorders | 17/42 |
| Age, Categorical(Participants) | Letrozole |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 40 |
| >=65 years | 2 |
| Age, Continuous(years) | Letrozole |
|---|---|
| Mean | 50 ± 7 |
| Sex: Female, Male(Participants) | Letrozole |
|---|---|
| Female | 42 |
| Male | 0 |
| Region of Enrollment(participants) | Letrozole |
|---|---|
| United States | 42 |
Plan to share: No — Global results will be published.
This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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Carol Fabian, MD