Actively Recruiting

Age: 18Years +
FEMALE
NCT06230185

CtDNA Based MRD Testing for NAC Monitoring in TNBC

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

A prospective, multicenter, observational study to evaluate the correlation of Molecular Residual Disease (MRD) detection using circulating tumor DNA guided test to pathological complete response (pCR) after neoadjuvant chemotherapy (NAC) in stage I-III triple negative breast cancer (TNBC). Results from this study aim to improve MRD detection and disease outcomes for future patients.

CONDITIONS

Official Title

CtDNA Based MRD Testing for NAC Monitoring in TNBC

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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Research Team

S

Soumya Chappidi

CONTACT

J

Julee Hartwell

CONTACT

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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CtDNA Based MRD Testing for NAC Monitoring in TNBC | DecenTrialz