Actively Recruiting
Breast Cancer MRD Detection and Monitoring in Early Stage Triple-Negative Breast Cancer Using ctDNA Testing A Prospective Observational Study
Led by Personalis Inc. · Updated on 2025-01-07
422
Participants Needed
14
Research Sites
111 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the correlation between Molecular Residual Disease (MRD) detected through circulating tumor DNA tests and pathological complete response (pCR) after neoadjuvant chemotherapy (NAC) in women with stage I-III triple-negative breast cancer (TNBC). This prospective, multicenter, observational study aims to improve MRD detection, which may help enhance disease outcomes for future patients with this breast cancer subtype. The study uses the NeXT Personal Clinical Trial Assay, a patient-specific, tumor-informed device that detects MRD from circulating free DNA (cfDNA). This method involves whole genome sequencing from tumor and normal samples to create a personalized DNA target panel. Plasma samples are then sequenced using next generation sequencing technology to analyze cfDNA and determine MRD status. Participants will provide blood samples before and during NAC treatment to monitor MRD. The study measures the correlation between MRD and pCR through study completion, averaging six months. Researchers will assess blood samples, biopsy tissue, and clinical outcomes while monitoring safety and treatment response throughout the study period.
CONDITIONS
Official Title
CtDNA Based MRD Testing for NAC Monitoring in TNBC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed triple-negative breast cancer (ER ≤10% by IHC, PR ≤10% by IHC, HER2 0 or 1+ by IHC or FISH ratio <2 or HER2 gene copy number <6)
- Early-stage breast cancer (stage I-III) planned for neoadjuvant chemotherapy with curative intent
- Informed of the investigational nature of the study and relevant trial details
- Able and willing to sign written informed consent according to institutional and federal guidelines
- At least 18 years old
- Scheduled to start neoadjuvant chemotherapy
- Willing to provide blood samples before and during treatment
- Available biopsy tissue
You will not qualify if you...
- Receiving anti-cancer therapy for another malignancy at the same time
- Stage IV breast cancer
- Current or history of another primary cancer within 5 years, except basal or squamous cell skin cancer or non-invasive malignancy
- History of allogeneic bone marrow or organ transplant
- Blood transfusion within 2 weeks before blood collection for ctDNA testing
- Already started systemic therapy for breast cancer
- Pregnant
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Trial Site Locations
Total: 14 locations
1
Arizona Oncology
Tucson, Arizona, United States, 85704
Actively Recruiting
2
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
Actively Recruiting
3
George Washington University
Washington D.C., District of Columbia, United States, 20037
Actively Recruiting
4
Mount Sinai Medical Center of Florida
Miami Beach, Florida, United States, 33140
Actively Recruiting
5
Comprehensive Hematology Oncology (ONare Alliance, LLC / Exigent Research, LLC
St. Petersburg, Florida, United States, 33709
Actively Recruiting
6
Illinois Cancer Care
Peoria, Illinois, United States, 61615
Actively Recruiting
7
Louisiana State University
New Orleans, Louisiana, United States, 70112
Actively Recruiting
8
Trinity Health-Michigan
Ypsilanti, Michigan, United States, 48197
Actively Recruiting
9
Nebraska Methodist
Omaha, Nebraska, United States, 68114
Actively Recruiting
10
Stony Brook University Cancer Center
Stony Brook, New York, United States, 11794
Actively Recruiting
11
Oregon Oncology Specialists
Salem, Oregon, United States, 97301
Actively Recruiting
12
Cancer Care Associates of York
York, Pennsylvania, United States, 17403
Actively Recruiting
13
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
14
Cancer Care Northwest
Spokane, Washington, United States, 99202
Actively Recruiting
Research Team
S
Soumya Chappidi
J
Julee Hartwell
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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