A Phase 2 interventional study of Tamoxifen Citrate and Letrozole in Breast Cancer, sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-05-07.
Sponsored by Johns Hopkins University · Phase 2, Interventional, and Basic science
The investigators would like to study the genetic and molecular outcomes that results after a short term neoadjuvant hormonal therapy on patients with breast cancer.
Breast cancer is among the most common malignancies in women in the United States. Over the years breast cancer management have dramatically developed from the extensive surgical approach toward the breast conservative approach. This was mainly due to the introduction of chemotherapy and hormonal therapy. Hormonal therapy in particular has been shown to improve the oncological outcomes of the breast cancer. However, while this is well documented in the clinical outcomes. Little is known in regards what happens on the genetic level. As such in this study the investigators would like to study the genetic and molecular outcomes that results after a short term neoadjuvant hormonal therapy on patients with breast cancer.
The hypothesis of this study is that short-term, preoperative hormonal treatment will induce genetic changes associated with reduced proliferation, including lower Ki67 expression, and changes in Estrogen Receptor (ER) and Progesterone Receptor (PR) expression. The data from such investigation will be very helpful in advancing the individualized care to women with breast cancer.
12,547 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 30 is below the median of 72 across 9,305 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.
Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria
for premenopausal patients
Drug: Tamoxifen Citrate · Diagnostic Test: Blueprint · Diagnostic Test: Mammaprint
for postmenopausal patients
Drug: Letrozole · Diagnostic Test: Blueprint · Diagnostic Test: Mammaprint
for postmenopausal patients
Drug: Exemestane · Diagnostic Test: Blueprint · Diagnostic Test: Mammaprint
10mg administered daily. Patients take this drug for 2-6 weeks
Also known as: Soltamox
2.5mg is administered daily. Patients take this drug for 2-6 weeks
Also known as: Femara
25mg is administered daily. Patients take this drug for 2-6 weeks.
Also known as: Aromasin
studies the genomics of the tumor and tumor behavior
studies the genomics of the tumor
Change in Percent Expression of Ki67 Measured by Immunohistochemistry (IHC)
This is a measure of tumor proliferation, and will be determined at baseline and at time of surgery.
Time frame: Baseline and at Time of surgery up to 6 weeks after the start of hormone therapy
Number of Participants With Low or High Score in MammaPrint
Mammaprint risk score is binary (high risk of recurrence or low risk of recurrence).
Time frame: Baseline and at Time of surgery (up to 6 weeks)
Median Percent of Tissue ER Positive
Median percent of tissue ER positive in matched tissue measured by Immunohistochemistry (IHC)
Time frame: Baseline and at Time of surgery (up to 6 weeks)
Median Percent of Tissue PR Positive
Median percent of tissue PR positive in matched tissue measured by Immunohistochemistry (IHC)
Time frame: Baseline and at Time of surgery (up to 6 weeks)
| Milestone | Tamoxifen Arm | Letrozole Arm | Exemestane Arm |
|---|---|---|---|
| Started | 10 | 10 | 10 |
| Completed | 10 | 10 | 10 |
| Not completed | 0 | 0 | 0 |
This is a measure of tumor proliferation, and will be determined at baseline and at time of surgery.
| Change in percentage expression of ki 67 | Tamoxifen Arm | Letrozole Arm | Exemestane Arm |
|---|---|---|---|
| Change in Percent Expression of Ki67 Measured by Immunohistochemistry (IHC) | -3.6 ± 1.06 | -5.1 ± 1.82 | -4.2 ± 1.71 |
Mammaprint risk score is binary (high risk of recurrence or low risk of recurrence).
| Participants | Tamoxifen Arm | Letrozole Arm | Exemestane Arm |
|---|---|---|---|
| low risk mammaprint score at baseline | 5 | 7 | 5 |
| high risk mammaprint score at baseline | 5 | 3 | 5 |
| low risk mammaprint score at time of surgery (up to 6 weeks) | 7 | 8 | 7 |
| high risk mammaprint score at time of surgery (up to 6 weeks) | 3 | 2 | 3 |
Median percent of tissue ER positive in matched tissue measured by Immunohistochemistry (IHC)
| percent of tissue ER positive | Tamoxifen Arm | Letrozole Arm | Exemestane Arm |
|---|---|---|---|
| Baseline median percent of tissue ER positive | 98 (67 to 100) | 93 (76 to 99) | 95 (50 to 100) |
| Time of surgery (up to 6 weeks) median percent of tissue ER positive | 95 (90 to 95) | 95 (60 to 97) | 95 (50 to 100) |
Median percent of tissue PR positive in matched tissue measured by Immunohistochemistry (IHC)
| percent of tissue PR positive | Tamoxifen Arm | Letrozole Arm | Exemestane Arm |
|---|---|---|---|
| Baseline median percent of tissue PR positive | 97 (67 to 100) | 33 (0 to 95) | 83 (0 to 100) |
| Time of surgery (up to 6 weeks) median percent of tissue PR positive | 90 (75 to 95) | 0 (0 to 71) | 7 (0 to 35) |
Collected over Up to 6 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tamoxifen Arm | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Letrozole Arm | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Exemestane Arm | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Age, Customized(participants) | Tamoxifen Arm | Letrozole Arm | Exemestane Arm | Total |
|---|---|---|---|---|
| below 55 | 7 | 0 | 0 | 7 |
| 55 and above | 3 | 10 | 10 | 23 |
| Sex: Female, Male(Participants) | Tamoxifen Arm | Letrozole Arm | Exemestane Arm | Total |
|---|---|---|---|---|
| Female | 9 | 10 | 10 | 29 |
| Male | 1 | 0 | 0 | 1 |
| Race/Ethnicity, Customized(participants) | Tamoxifen Arm | Letrozole Arm | Exemestane Arm | Total |
|---|---|---|---|---|
| Caucasian | 6 | 5 | 4 | 15 |
| African American | 4 | 5 | 6 | 15 |
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