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Evaluating Minimal Residual Disease (MRD) Through Longitudinal Circulating Tumor DNA (ctDNA) Profiling in Breast Malignancies

NCT07211178 · Tempus AI
In plain English

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About this study
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 criteria
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.
Study design
Enrollment target: 900 participants
Age groups: adult, older_adult
Timeline
Starts: 2025-10-27
Estimated completion: 2033-12
Last updated: 2026-09-03
Interventions
Other: There are no interventions in this observational study.
Primary outcomes
  • 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)
Sponsor
Tempus AI · industry
Contacts & investigators
ContactGEMINI Breast Clinical Study Manager · contact · gemini-breast@tempus.com · (833) 514-4187
InvestigatorMichelle Ting-Lin, MD · principal_investigator, Tempus AI
All locations (16)
Birmingham Hematology AssociatesRecruiting
Birmingham, Alabama, United States
PIH Health Whittier HospitalRecruiting
Whittier, California, United States
Cleveland Clinic FloridaRecruiting
Weston, Florida, United States
Southern Illinois Hospital ServicesRecruiting
Carbondale, Illinois, United States
Cancer Care Specialist of IllinoisRecruiting
O'Fallon, Illinois, United States
Goshen Center for Cancer CareRecruiting
Goshen, Indiana, United States
Trinity HealthRecruiting
Ann Arbor, Michigan, United States
Oncology Hematology AssociatesRecruiting
Springfield, Missouri, United States
Cancer Care Specialist of RenoRecruiting
Reno, Nevada, United States
Summit Medical GroupRecruiting
Florham Park, New Jersey, United States
University of Cincinnati Medical CenterRecruiting
Cincinnati, Ohio, United States
Sanford - Sioux FallsRecruiting
Sioux Falls, South Dakota, United States
Nashville GeneralRecruiting
Nashville, Tennessee, United States
UT Health HoustonRecruiting
Houston, Texas, United States
Cancer Care NorthwestRecruiting
Spokane Valley, Washington, United States
Gunderson HealthRecruiting
La Crosse, Wisconsin, United States
Evaluating Minimal Residual Disease (MRD) Through Longitudinal Circulating Tumor DNA (ctDNA) Profiling in Breast Malignancies · TrialPath