Breast CancerTNBC - Triple-Negative Breast CancerHR Positive/HER-2 Negative Breast CancerHER2 + Breast CancerEarly Stage Breast Cancer
Investigational drug(s) / intervention(s)
There are no interventions in this observational study.
There are no interventions in this observational study.: There are no interventions in this observational study.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
99 Years
Healthy volunteers
No
Inclusion Criteria:
All Cohorts:
1. Willing and able to participate in the research and provide biospecimens
2. Willing and able to provide informed consent
3. Must be diagnosed with breast cancer
Cohort 1: Neoadjuvant Treatment Cohort 1A: Newly Diagnosed, High Risk HR+,HER2-
1. A known or suspected HR+, HER2- breast cancer treated with curative intent (Stage II to III disease)
2. Patients are considered at high risk of recurrence, defined as 4 or more positive axillary lymph nodes (ALNs), or between 1-3 positive ALNs and either grade 3 disease or tumor size of 5 cm or larger.
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-
1. A known or suspected HR+, HER2- breast cancer treated with curative intent (Stage II to III disease)
2. Patients are considered at high risk of recurrence, defined as 4 or more positive axillary lymph nodes (ALNs), or between 1-3 positive ALNs and either grade 3 disease or tumor size of 5 cm or larger.
3. Have undergone curative intent surgery with no clinical evidence of disease.
Cohort 2B: HER2+
1. A known or suspected HER2+ breast cancer treated with curative intent (Stage II to III disease)
2. Have undergone curative intent surgery with no clinical evidence of disease.
Cohort 2C: Triple Negative Breast Cancer
1. A known or suspected triple negative breast cancer treated with curative intent (Stage I to III disease)
2. Have undergone curative intent surgery with no clinical evidence of disease.
Cohort 3: 5-Years Post-Diagnosis Surveillance (NED)
1. A known HR+, HER2- breast cancer treated with curative intent (Stage II to III disease).
2. No Evidence of Disease (NED) ≥ 5 years from initial diagnosis.
3. Patients are considered at high risk of recurrence, defined as 4 or more positive axillary lymph nodes (ALNs), or between 1-3 positive ALNs and either grade 3 disease or tumor size of 5 cm or larger.
Exclusion Criteria:
1. Not willing or able to adhere with the study procedures
2. Active secondary malignancy
3. Diagnosis of a malignancy within 3 years of breast cancer diagnosis Note: Ductal carcinoma in situ (DCIS, ipsilateral or contralateral) within 3 years is not excluded.
Primary outcome measure(s)
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
Trial sites (16)
Facility
City
Region
Status
Birmingham Hematology Associates
Birmingham
Alabama
Recruiting
PIH Health Whittier Hospital
Whittier
California
Recruiting
Cleveland Clinic Florida
Weston
Florida
Recruiting
Southern Illinois Hospital Services
Carbondale
Illinois
Recruiting
Cancer Care Specialist of Illinois
O'Fallon
Illinois
Recruiting
Goshen Center for Cancer Care
Goshen
Indiana
Recruiting
Trinity Health
Ann Arbor
Michigan
Recruiting
Oncology Hematology Associates
Springfield
Missouri
Recruiting
Cancer Care Specialist of Reno
Reno
Nevada
Recruiting
Summit Medical Group
Florham Park
New Jersey
Recruiting
University of Cincinnati Medical Center
Cincinnati
Ohio
Recruiting
Sanford - Sioux Falls
Sioux Falls
South Dakota
Recruiting
Nashville General
Nashville
Tennessee
Recruiting
UT Health Houston
Houston
Texas
Recruiting
Cancer Care Northwest
Spokane Valley
Washington
Recruiting
Gunderson Health
La Crosse
Wisconsin
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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