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Recruiting NCT06230185

CtDNA Based MRD Testing for NAC Monitoring in TNBC

— Observational TNBC - Triple-Negative Breast Cancer Minimal Residual Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: TNBC - Triple-Negative Breast Cancer, Minimal Residual Disease. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

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.

Primary outcome measures

  • Evaluate the correlation of MRD to pCR after NAC in TNBC [Time frame: through study completion, an average of 6 months]
Secondary outcome measures (1)
  • Evaluate the trajectory of changes in MRD to pCR or non pCR in TNBC [Time frame: through study completion, an average of 6 months]

Eligibility criteria

Inclusion criteria

  • 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).
  • Early-stage breast cancer (stage I-III) and scheduled to undergo NAC treatment with curative intent.
  • Be informed of the investigational nature of the study and all pertinent aspects of the trial.
  • Have the ability to understand and the willingness to sign a written informed consent document in accordance with institutional and federal guidelines.
  • Be ≥ 18years of age.
  • Patient who are scheduled to start NAC.
  • Be willing to provide blood samples before and during treatment.
  • Have available biopsy tissue.

Exclusion criteria

  • Receiving concurrent anti-neoplastic therapy for another malignancy.
  • Stage IV disease.
  • 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.
  • History of allogeneic bone marrow or organ transplant.
  • Blood transfusion within two weeks before collection of blood for central ctDNA testing.
  • Started systemic therapy for their breast cancer.
  • Pregnancy

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 14 centers
  • Arizona Oncology — Tucson
  • University of Colorado Cancer Center — Aurora
  • George Washington University — Washington D.C.
  • Mount Sinai Medical Center of Florida — Miami Beach
  • Comprehensive Hematology Oncology (ONare Alliance, LLC / Exigent Research, LLC — St. Petersburg
  • Illinois Cancer Care — Peoria
  • Louisiana State University — New Orleans
  • Trinity Health-Michigan — Ypsilanti
  • … and 6 more centers

Identifiers

NCT: NCT06230185 · 01-PS-001 · B-STRONGER-I

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗