Actively Recruiting

Age: 18Years +
FEMALE
ID06230185

Breast Cancer Molecular Residual Disease Detection and Therapy Monitoring in Early Stage Triple Negative Breast Cancer

Led by Personalis Inc. · Updated on 2025-01-07

422

Participants Needed

14

Research Sites

17 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating the relationship between Molecular Residual Disease (MRD) detected through circulating tumor DNA and pathological complete response (pCR) following neoadjuvant chemotherapy (NAC) in patients with stage I-III triple negative breast cancer (TNBC). This observational study aims to improve MRD detection methods and potentially enhance disease outcomes for future patients. The study uses the NeXT Personal Clinical Trial Assay (CTA), a patient-specific, tumor-informed test that detects MRD from cell-free DNA in blood plasma. This involves sequencing DNA from tumor and normal samples to create a personalized DNA panel, which is then applied to analyze plasma samples during and after chemotherapy treatment. No interventional treatments are administered as this is an observational study. Participants provide blood samples before and during chemotherapy, and their available biopsy tissue is used for analysis. Researchers will evaluate the correlation between MRD status and pCR over an average of 6 months. The study includes assessments using next generation sequencing and bioinformatics to monitor MRD, with no additional treatments or interventions required. Participation duration and follow-up are aligned with the chemotherapy schedule and study completion timeframe.

CONDITIONS

Brief Title

CtDNA Based MRD Testing for NAC Monitoring in TNBC

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Have histologically documented triple negative breast cancer (ER ≤10% by IHC, PR ≤10% by IHC, and HER2 0 or 1+ by IHC or FISH ratio <2 or HER2 gene copy number <6).
  • Early-stage breast cancer (stage I-III) scheduled for neoadjuvant chemotherapy with curative intent.
  • Understand and are willing to sign informed consent.
  • Are 18 years of age or older.
  • Scheduled to start neoadjuvant chemotherapy.
  • Willing to provide blood samples before and during treatment.
  • Have available biopsy tissue.
Not Eligible

You will not qualify if you...

  • Receiving anti-cancer therapy for another malignancy.
  • Have stage IV breast cancer.
  • Have 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.
  • Received blood transfusion within two weeks before blood collection for testing.
  • Started systemic therapy for breast cancer.
  • Are pregnant.

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - Approximately 6 months

Participants provide blood samples before and during neoadjuvant chemotherapy to detect molecular residual disease using a personalized tumor-informed assay.

Multiple blood sample collections during treatment period

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

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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