ctDNA Based MRD Testing for NAC Monitoring in TNBC

Description

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

TNBC - Triple-Negative Breast Cancer, Minimal Residual Disease

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Study Overview

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Study Details

Study overview

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.

Breast Cancer-Minimal/Molecular Residual Disease Detection and Therapy Monitoring in Patients With Early Stage TNBC-Phase I (B-STRONGER-I)

ctDNA Based MRD Testing for NAC Monitoring in TNBC

Condition
TNBC - Triple-Negative Breast Cancer
Intervention / Treatment

-

Contacts and Locations

Stony Brook

Alison Stopeck, Stony Brook, New York, United States, 11794

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Have histologically documented TNBC (defined as ER expression ≤10% by IHC, PR expression≤10% by IHC and HER2 0 or 1+ by IHC or FISH ratio \<2 or HER2 gene copy number of \<6).
  • 2. Early-stage breast cancer (stage I-III) and scheduled to undergo NAC treatment with curative intent.
  • 3. Be informed of the investigational nature of the study and all pertinent aspects of the trial.
  • 4. Have the ability to understand and the willingness to sign a written informed consent document in accordance with institutional and federal guidelines.
  • 5. Be ≥ 18years of age.
  • 6. Patient who are scheduled to start NAC.
  • 7. Be willing to provide blood samples before and during treatment.
  • 8. Have available biopsy tissue.
  • 1. Receiving concurrent anti-neoplastic therapy for another malignancy.
  • 2. Stage IV disease.
  • 3. Current or history of another primary cancer within 5 years of study entry, with the exception of basal or squamous cell skin cancer, or non-invasive malignancy.
  • 4. History of allogeneic bone marrow or organ transplant.
  • 5. Blood transfusion within two weeks before collection of blood for central ctDNA testing.
  • 6. Started systemic therapy for their breast cancer.
  • 7. Pregnancy

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Personalis Inc.,

Pavani Chalasani, PRINCIPAL_INVESTIGATOR, George Washington University

Study Record Dates

2025-12-31