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For patients with breast cancer, it's important to find any remaining cancer cells after they've had their main treatment. Even a few cells, called minimal residual disease (MRD), can lead to the cancer coming back later.
A way to find these cells is by looking for tiny bits of cancer DNA that are shed into the blood. This is called circulating tumor DNA (ctDNA). A simple blood test, often called a liquid biopsy, can detect this ctDNA. This research aims to see if finding this cancer DNA in the blood can help predict if a patient's cancer will return. It also may help find out if the treatment is working.
Ultimately, the results of this research may help doctors better manage breast cancer and develop new and improved tests and treatments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Neoadjuvant Therapy | There are no interventions in this observational study. Cohort 1 includes participants who will receive neoadjuvant treatment prior to surgery. |
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| Cohort 2: Adjuvant Therapy / Surveillance | There are no interventions in this observational study. Cohort 2 includes participants who will receive adjuvant therapy after surgery. |
| |
| Cohort 3: 5 Years Post-Diagnosis Surveillance | There are no interventions in this observational study. Cohort 3 includes participants who have no evidence of disease for at least 5 years post diagnosis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| There are no interventions in this observational study. | Other | There are no interventions in this observational study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Invasive Disease-Free Survival (iDFS) stratified by MRD status during neoadjuvant, post-surgery landmark, post definitive treatment (surveillance), and long-term follow-up | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Distant disease free survival rates stratified by MRD status during neoadjuvant treatment | 5 years | |
| Overall Survival rates stratified by MRD status during neoadjuvant treatment, post-surgery landmark, post definitive treatment (surveillance), and long-term follow-up |
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Inclusion Criteria:
All Cohorts:
Cohort 1: Neoadjuvant Treatment Cohort 1A: Newly Diagnosed, High Risk HR+,HER2-
Cohort 1B: HER2+ 1. A known or suspected HER2+ breast cancer treated with curative intent (Stage II to III disease). Inclusive of HR+ or HR- patients.
Cohort 1C: Triple Negative Breast Cancer
1. A known or suspected triple negative breast cancer treated with curative intent (Stage I to III disease).
Cohort 2: Adjuvant Therapy / Surveillance Cohort 2A: Newly Diagnosed HR+,HER2-
Cohort 2B: HER2+
Cohort 2C: Triple Negative Breast Cancer
Cohort 3: 5-Years Post-Diagnosis Surveillance (NED)
Exclusion Criteria:
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The population of this study includes early stage breast cancer patients with triple negative breast cancer (Stages I to III), HER2 positive (Stages II and III), and high risk HR positive HER-2 negative (Stages II and III).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| GEMINI Breast Clinical Study Manager | Contact | (833) 514-4187 | gemini-breast@tempus.com |
| Name | Affiliation | Role |
|---|---|---|
| Michelle Ting-Lin, MD | Tempus AI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham Hematology Associates | Recruiting | Birmingham | Alabama | 35223 | United States |
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Saliva, blood and leftover tissue will be collected in the study.
| 5 years |
| Pathologic Complete Response (pCR) or Residual Cancer Burden (RCB) rate stratified by MRD status at post-surgery landmark | 5 years |
| Time from First Positive MRD Sample to Recurrence | 5 years |
| PIH Health Whittier Hospital | Recruiting | Whittier | California | 90602 | United States |
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| Cleveland Clinic Florida | Recruiting | Weston | Florida | 33331 | United States |
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| Southern Illinois Hospital Services | Recruiting | Carbondale | Illinois | 62902 | United States |
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| Cancer Care Specialist of Illinois | Recruiting | O'Fallon | Illinois | 62269 | United States |
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| Goshen Center for Cancer Care | Recruiting | Goshen | Indiana | 46526 | United States |
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| Trinity Health | Recruiting | Ann Arbor | Michigan | 48106 | United States |
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| Oncology Hematology Associates | Recruiting | Springfield | Missouri | 65807 | United States |
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| Cancer Care Specialist of Reno | Recruiting | Reno | Nevada | 89511 | United States |
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| Summit Medical Group | Recruiting | Florham Park | New Jersey | 07932 | United States |
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| University of Cincinnati Medical Center | Recruiting | Cincinnati | Ohio | 45219 | United States |
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| Nashville General | Recruiting | Nashville | Tennessee | 37208 | United States |
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| Cancer Care Northwest | Recruiting | Spokane Valley | Washington | 99216 | United States |
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| Gunderson Health | Recruiting | La Crosse | Wisconsin | 54601 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D064726 | Triple Negative Breast Neoplasms |
| D018365 | Neoplasm, Residual |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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