Actively Recruiting
Evaluating Minimal Residual Disease Through Longitudinal Circulating Tumor DNA Profiling in Breast Malignancies
Led by Tempus AI · Updated on 2026-03-04
900
Participants Needed
12
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating how detecting minimal residual disease (MRD) through circulating tumor DNA (ctDNA) in the blood can help predict breast cancer recurrence. This study focuses on patients with breast cancer, including various types such as triple-negative, HR positive/HER-2 negative, and HER2 positive breast cancers. The aim is to see if tracking ctDNA after treatment can improve cancer management and guide development of better tests and treatments. This is an observational study without treatments. Participants are divided into three groups: those receiving neoadjuvant therapy before surgery, those undergoing adjuvant therapy or surveillance after surgery, and those who have been disease-free for at least five years post diagnosis. Each group will be followed to monitor ctDNA levels over time. Participants will provide blood samples and other biospecimens at scheduled intervals for up to five years. Researchers will assess invasive disease-free survival and overall survival, along with other outcomes like distant disease-free survival and time from first positive MRD to recurrence. This long-term follow-up aims to understand how ctDNA detection relates to cancer outcomes and treatment effectiveness.
CONDITIONS
Brief Title
Evaluating Minimal Residual Disease (MRD) Through Longitudinal Circulating Tumor DNA (ctDNA) Profiling in Breast Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to participate in the research and provide biospecimens
- Willing and able to provide informed consent
- Must be diagnosed with breast cancer
- For Cohort 1A: Known or suspected HR+, HER2- breast cancer treated with curative intent (Stage II to III)
- High risk of recurrence defined by 4 or more positive axillary lymph nodes, or 1-3 positive ALNs with grade 3 disease or tumor size 5 cm or larger
- For Cohort 1B: Known or suspected HER2+ breast cancer treated with curative intent (Stage II to III), including HR+ or HR- patients
- For Cohort 1C: Known or suspected triple negative breast cancer treated with curative intent (Stage I to III)
- For Cohort 2A: Known or suspected HR+, HER2- breast cancer treated with curative intent (Stage II to III), post curative surgery with no clinical evidence of disease
- For Cohort 2B: Known or suspected HER2+ breast cancer treated with curative intent (Stage II to III), post curative surgery with no clinical evidence of disease
- For Cohort 2C: Known or suspected triple negative breast cancer treated with curative intent (Stage I to III), post curative surgery with no clinical evidence of disease
- For Cohort 3: Known HR+, HER2- breast cancer treated with curative intent (Stage II to III)
- No evidence of disease for 5 or more years since diagnosis
- High risk of recurrence defined by 4 or more positive axillary lymph nodes, or 1-3 positive ALNs with grade 3 disease or tumor size 5 cm or larger
You will not qualify if you...
- Not willing or able to adhere to the study procedures
- Active secondary malignancy
- Diagnosis of another malignancy within 3 years of breast cancer diagnosis (except ductal carcinoma in situ within 3 years)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 5 years
Participants are observed over time to monitor minimal residual disease through blood samples without receiving any interventions.
Periodic visits depending on cohort assignment for blood sample collection
Trial Site Locations
Total: 12 locations
1
Birmingham Hematology Associates
Birmingham, Alabama, United States, 35223
Actively Recruiting
2
PIH Health Whittier Hospital
Whittier, California, United States, 90602
Actively Recruiting
3
Southern Illinois Hospital Services
Carbondale, Illinois, United States, 62902
Actively Recruiting
4
Cancer Care Specialist of Illinois
O'Fallon, Illinois, United States, 62269
Actively Recruiting
5
Goshen Center for Cancer Care
Goshen, Indiana, United States, 46526
Actively Recruiting
6
Trinity Health
Ann Arbor, Michigan, United States, 48106
Actively Recruiting
7
Oncology Hematology Associates
Springfield, Missouri, United States, 65807
Actively Recruiting
8
Cancer Care Specialist of Reno
Reno, Nevada, United States, 89511
Actively Recruiting
9
Summit Medical Group
Florham Park, New Jersey, United States, 07932
Actively Recruiting
10
Nashville General
Nashville, Tennessee, United States, 37208
Actively Recruiting
11
Cancer Care Northwest
Spokane Valley, Washington, United States, 99216
Actively Recruiting
12
Gunderson Health
La Crosse, Wisconsin, United States, 54601
Actively Recruiting
Research Team
G
GEMINI Breast Clinical Study Manager
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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