CtDNA Based MRD Testing for NAC Monitoring in TNBC
B-STRONGER-I
Breast Cancer-Minimal/Molecular Residual Disease Detection and Therapy Monitoring in Patients with Early Stage TNBC-Phase I (B-STRONGER-I)
2 other identifiers
observational
422
1 country
14
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2023
Typical duration for all trials
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 9, 2023
CompletedFirst Submitted
Initial submission to the registry
January 9, 2024
CompletedFirst Posted
Study publicly available on registry
January 30, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedJanuary 7, 2025
January 1, 2025
1.8 years
January 9, 2024
January 3, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluate the correlation of MRD to pCR after NAC in TNBC
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 Outcomes (1)
Evaluate the trajectory of changes in MRD to pCR or non pCR in TNBC
through study completion, an average of 6 months
Other Outcomes (2)
Stratification based on NAC therapy regimen
through study completion, an average of 6 months
Evaluate genomic profiles
through study completion, an average of 6 months
Eligibility Criteria
Female patient who are scheduled to start NAC with early-stage Triple Negative Breast Cancer.
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Personalis Inc.lead
Study Sites (14)
Arizona Oncology
Tucson, Arizona, 85704, United States
University of Colorado Cancer Center
Aurora, Colorado, 80045, United States
George Washington University
Washington D.C., District of Columbia, 20037, United States
Mount Sinai Medical Center of Florida
Miami Beach, Florida, 33140, United States
Comprehensive Hematology Oncology (ONare Alliance, LLC / Exigent Research, LLC
St. Petersburg, Florida, 33709, United States
Illinois Cancer Care
Peoria, Illinois, 61615, United States
Louisiana State University
New Orleans, Louisiana, 70112, United States
Trinity Health-Michigan
Ypsilanti, Michigan, 48197, United States
Nebraska Methodist
Omaha, Nebraska, 68114, United States
Stony Brook University Cancer Center
Stony Brook, New York, 11794, United States
Oregon Oncology Specialists
Salem, Oregon, 97301, United States
Cancer Care Associates of York
York, Pennsylvania, 17403, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Cancer Care Northwest
Spokane, Washington, 99202, United States
Biospecimen
FFPE, DNA extracted from blood, ctDNA extracted from plasma
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pavani Chalasani
George Washington University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Division of Hematology and Oncology
Study Record Dates
First Submitted
January 9, 2024
First Posted
January 30, 2024
Study Start
November 9, 2023
Primary Completion
August 30, 2025
Study Completion
December 31, 2025
Last Updated
January 7, 2025
Record last verified: 2025-01