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| Name | Class |
|---|---|
| Agendia | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tamoxifen arm | Experimental | for premenopausal patients |
|
| Letrozole arm | Experimental | for postmenopausal patients |
|
| Exemestane arm | Experimental | for postmenopausal patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tamoxifen Citrate | Drug | 10mg administered daily. Patients take this drug for 2-6 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and at Time of surgery up to 6 weeks after the start of hormone therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Low or High Score in MammaPrint | Mammaprint risk score is binary (high risk of recurrence or low risk of recurrence). | Baseline and at Time of surgery (up to 6 weeks) |
| Median Percent of Tissue ER Positive |
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Inclusion criteria
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Mehran Habibi, MD | Johns Hopkins Bayview | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Bayview Hospital | Baltimore | Maryland | 21224 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26408301 | Background | Suman VJ, Ellis MJ, Ma CX. The ALTERNATE trial: assessing a biomarker driven strategy for the treatment of post-menopausal women with ER+/Her2- invasive breast cancer. Chin Clin Oncol. 2015 Sep;4(3):34. doi: 10.3978/j.issn.2304-3865.2015.09.01. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tamoxifen Arm | for premenopausal patients Tamoxifen Citrate: 10mg administered daily. Patients take this drug for 2-6 weeks Blueprint: studies the genomics of the tumor and tumor behavior Mammaprint: studies the genomics of the tumor |
| FG001 | Letrozole Arm | for postmenopausal patients Letrozole: 2.5mg is administered daily. Patients take this drug for 2-6 weeks Blueprint: studies the genomics of the tumor and tumor behavior Mammaprint: studies the genomics of the tumor |
| FG002 | Exemestane Arm | for postmenopausal patients Exemestane: 25mg is administered daily. Patients take this drug for 2-6 weeks. Blueprint: studies the genomics of the tumor and tumor behavior Mammaprint: studies the genomics of the tumor |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tamoxifen Arm | for premenopausal patients Tamoxifen Citrate: 10mg administered daily. Patients take this drug for 2-6 weeks Blueprint: studies the genomics of the tumor and tumor behavior Mammaprint: studies the genomics of the tumor |
| BG001 | Letrozole Arm |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | Change in percentage expression of ki 67 | Baseline and at Time of surgery up to 6 weeks after the start of hormone therapy |
|
Up to 6 weeks
all adverse effects were collected
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tamoxifen Arm | for premenopausal patients Tamoxifen Citrate: 10mg administered daily. Patients take this drug for 2-6 weeks Blueprint: studies the genomics of the tumor and tumor behavior Mammaprint: studies the genomics of the tumor |
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small number of participants
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mehran Habibi | Johns Hopkins University | 4105505522 | mhabibi2@jhmi.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 18, 2020 | Nov 5, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D013629 | Tamoxifen |
| D000077289 | Letrozole |
| C056516 | exemestane |
| ID | Term |
|---|---|
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
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Patients will start the hormone therapy before surgery; the investigators look for the genomic profiles of the tumor before and after chemotherapy
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| Letrozole | Drug | 2.5mg is administered daily. Patients take this drug for 2-6 weeks |
|
|
| Exemestane | Drug | 25mg is administered daily. Patients take this drug for 2-6 weeks. |
|
|
| Blueprint | Diagnostic Test | studies the genomics of the tumor and tumor behavior |
|
| Mammaprint | Diagnostic Test | studies the genomics of the tumor |
|
Median percent of tissue ER positive in matched tissue measured by Immunohistochemistry (IHC)
| 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) | Baseline and at Time of surgery (up to 6 weeks) |
for postmenopausal patients Letrozole: 2.5mg is administered daily. Patients take this drug for 2-6 weeks Blueprint: studies the genomics of the tumor and tumor behavior Mammaprint: studies the genomics of the tumor |
| BG002 | Exemestane Arm | for postmenopausal patients Exemestane: 25mg is administered daily. Patients take this drug for 2-6 weeks. Blueprint: studies the genomics of the tumor and tumor behavior Mammaprint: studies the genomics of the tumor |
| BG003 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| OG002 | Exemestane Arm | for postmenopausal patients Exemestane: 25mg is administered daily. Patients take this drug for 2-6 weeks. Blueprint: studies the genomics of the tumor and tumor behavior Mammaprint: studies the genomics of the tumor |
|
|
| Secondary | Number of Participants With Low or High Score in MammaPrint | Mammaprint risk score is binary (high risk of recurrence or low risk of recurrence). | Posted | Count of Participants | Participants | Baseline and at Time of surgery (up to 6 weeks) |
|
|
|
| Secondary | Median Percent of Tissue ER Positive | Median percent of tissue ER positive in matched tissue measured by Immunohistochemistry (IHC) | Posted | Median | Full Range | percent of tissue ER positive | Baseline and at Time of surgery (up to 6 weeks) |
|
|
|
| Secondary | Median Percent of Tissue PR Positive | Median percent of tissue PR positive in matched tissue measured by Immunohistochemistry (IHC) | Posted | Median | Full Range | percent of tissue PR positive | Baseline and at Time of surgery (up to 6 weeks) |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Letrozole Arm | for postmenopausal patients Letrozole: 2.5mg is administered daily. Patients take this drug for 2-6 weeks Blueprint: studies the genomics of the tumor and tumor behavior Mammaprint: studies the genomics of the tumor | 0 | 10 | 0 | 10 | 0 | 10 |
| EG002 | Exemestane Arm | for postmenopausal patients Exemestane: 25mg is administered daily. Patients take this drug for 2-6 weeks. Blueprint: studies the genomics of the tumor and tumor behavior Mammaprint: studies the genomics of the tumor | 0 | 10 | 0 | 10 | 0 | 10 |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
|
| low risk mammaprint score at time of surgery (up to 6 weeks) |
|
| high risk mammaprint score at time of surgery (up to 6 weeks) |
|
|
|