CtDNA Based MRD Testing for NAC Monitoring in TNBC (B-STRONGER-I)

January 3, 2025 updated by: Pavani Chalasani, Personalis Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

NeXT Personal CTA (Clinical Trial Assay) is a patient-specific, tumor-informed device which allows for detection of MRD from cfDNA. By using next generation sequencing technology, whole genome sequencing (WGS) is conducted from DNA derived from patient tumor and normal samples. A tumor informed personalized panel is then constructed that uses only a selection of DNA targets from the WGS by applying bioinformatic filters. The targeted personalized panel is then sequenced using NGS and DNA derived from cfDNA from plasma samples. The data from the cfDNA NGS are then further analyzed using bioinformatics filters to report the MRD status.

Study Type

Observational

Enrollment (Estimated)

422

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85704
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado Cancer Center
        • Contact:
        • Contact:
          • Peter Kabos, MD
    • District of Columbia
      • Washington DC, District of Columbia, United States, 20037
        • Recruiting
        • George Washington University
        • Contact:
          • Pavani Chalasani, MD
        • Contact:
    • Florida
      • Miami Beach, Florida, United States, 33140
        • Recruiting
        • Mount Sinai Medical Center of Florida
        • Contact:
        • Contact:
          • Oleg Gligich, MD
      • St. Petersburg, Florida, United States, 33709
        • Recruiting
        • Comprehensive Hematology Oncology (ONare Alliance, LLC / Exigent Research, LLC
        • Contact:
        • Contact:
          • Neeharika Makani, MD
    • Illinois
      • Peoria, Illinois, United States, 61615
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Recruiting
        • Louisiana State University
        • Contact:
        • Contact:
          • Michelle Loch, MD
    • Michigan
      • Ypsilanti, Michigan, United States, 48197
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Recruiting
        • Nebraska Methodist
        • Contact:
        • Contact:
          • Kristen Leu, MD
    • New York
      • Stony Brook, New York, United States, 11794
    • Oregon
      • Salem, Oregon, United States, 97301
        • Recruiting
        • Oregon Oncology Specialists
        • Contact:
        • Contact:
          • Janelle Meyer, MD
    • Pennsylvania
      • York, Pennsylvania, United States, 17403
        • Recruiting
        • Cancer Care Associates of York
        • Contact:
        • Contact:
          • Joyce Huang, MD
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • The University of Texas MD Anderson Cancer Center
        • Contact:
        • Contact:
          • Carlos Hernando Barcenas, MD
    • Washington
      • Spokane, Washington, United States, 99202
        • Recruiting
        • Cancer Care Northwest
        • Contact:
        • Contact:
          • Kristen Rinn, MD

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Female patient who are scheduled to start NAC with early-stage Triple Negative Breast Cancer.

Description

Inclusion 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.

Exclusion Criteria:

  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the correlation of MRD to pCR after NAC in TNBC
Time Frame: through study completion, an average of 6 months
Evaluate the correlation of MRD detection by NeXT Personal CTA to pathological Complete Response (pCR) after neoadjuvant chemotherapy (NAC) in stage I-III triple negative breast cancer (TNBC). The pCR is defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy.
through study completion, an average of 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the trajectory of changes in MRD to pCR or non pCR in TNBC
Time Frame: through study completion, an average of 6 months
Evaluate the trajectory of changes in MRD detected by NeXT Personal CTA during neoadjuvant chemotherapy (NAC) to pathological Complete Response (pCR) or non pCR in stage I-III triple negative breast cancer (TNBC).
through study completion, an average of 6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stratification based on NAC therapy regimen
Time Frame: through study completion, an average of 6 months
NeXT Personal CTA clinical accuracy may be evaluated as compared to other clinically available tests. Stratification based on NAC therapy regimen, genomic profiles and biomarker analysis.
through study completion, an average of 6 months
Evaluate genomic profiles
Time Frame: through study completion, an average of 6 months
Evaluate genomic profile for specific biomarkers during neoadjuvant chemotherapy (NAC)
through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Personalis Inc.

Investigators

  • Principal Investigator: Pavani Chalasani, George Washington University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 9, 2023

Primary Completion (Estimated)

August 30, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

January 9, 2024

First Submitted That Met QC Criteria

January 18, 2024

First Posted (Actual)

January 30, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 3, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01-PS-001
  • B-STRONGER-I (Other Identifier: Personalis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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