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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Personalis Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 9, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 9, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 18, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 30, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 3, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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