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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2022-04802 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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insufficient funding
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The purpose of this study is to study to collect tissue samples from patients with early stage hormone receptor-positive HER2-negative breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with early-stage hormone receptor-positive HER2-negative breast cancer receiving letrozole | Patients undergo collection of blood and tissue samples prior to beginning treatment with letrozole and at least two weeks after the start of letrozole treatment, but prior to surgery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biospecimen Collection | Procedure | Undergo collection of blood and tissue samples |
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| Measure | Description | Time Frame |
|---|---|---|
| Differences in tumor microenvironment subpopulations in aromatase inhibitor (AI)-sensitive version (vs.) AI-resistant hormone receptor (HR)+ breast cancer | Tissue samples from patients with early-stage hormone receptor-positive HER2-negative breast cancer will be collected to compare differences. | Up to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Effects of estrogen deprivation on the immune microenvironment | Estrogen receptor will be evaluated by both biopsy and surgical specimens. | Up to 8 weeks |
| Effects of estrogen deprivation on tumor immune microenvironment |
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Inclusion Criteria:
Exclusion Criteria:
Immunocompromised patients including patients known to be human immunodeficiency virus (HIV) positive or those on chronic steroids
Known history of active autoimmune disease that has required systemic treatment within =< 30 days (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs) prior to pre-registration
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Patients with early-stage hormone receptor-positive HER2-negative breast cancer
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| Name | Affiliation | Role |
|---|---|---|
| Saranya Chumsri, M.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Florida | Jacksonville | Florida | 32224-9980 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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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 | Dec 1, 2022 | Jun 9, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 8, 2023 | Jun 9, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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Samples store for future research with consent of participants
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Estrogen receptor will be evaluated by both biopsy and surgical specimens.
| Up to 8 weeks |