RECRUITING

ctDNA Based MRD Testing for NAC Monitoring in TNBC

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Conditions

TNBC - Triple-Negative Breast CancerMinimal Residual DiseasectDNALiquid BiopsyBreast CancerMRDNACTNBCNeXT Personal®

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-11-09
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06230185

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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. 2. Early-stage breast cancer (stage I-III) and scheduled to undergo NAC treatment with curative intent.
  3. 3. Be informed of the investigational nature of the study and all pertinent aspects of the trial.
  4. 4. Have the ability to understand and the willingness to sign a written informed consent document in accordance with institutional and federal guidelines.
  5. 5. Be ≥ 18years of age.
  6. 6. Patient who are scheduled to start NAC.
  7. 7. Be willing to provide blood samples before and during treatment.
  8. 8. Have available biopsy tissue.
  1. 1. Receiving concurrent anti-neoplastic therapy for another malignancy.
  2. 2. Stage IV disease.
  3. 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. 4. History of allogeneic bone marrow or organ transplant.
  5. 5. Blood transfusion within two weeks before collection of blood for central ctDNA testing.
  6. 6. Started systemic therapy for their breast cancer.
  7. 7. Pregnancy

Contacts and Locations

Study Contact

Ruth Stone
CONTACT
518 669 9232
restone@criteriuminc.com
Julee Hartwell
CONTACT
607-651-6273
jhartwell@criteriuminc.com

Principal Investigator

Pavani Chalasani
PRINCIPAL_INVESTIGATOR
George Washington University

Study Locations (Sites)

Alison Stopeck
Stony Brook, New York, 11794
United States

Collaborators and Investigators

Sponsor: Personalis Inc.

  • Pavani Chalasani, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2023-11-09
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2023-11-09
Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

  • ctDNA
  • Liquid Biopsy
  • Breast Cancer
  • MRD
  • NAC
  • TNBC
  • NeXT Personal®

Additional Relevant MeSH Terms

  • TNBC - Triple-Negative Breast Cancer
  • Minimal Residual Disease