CtDNA Based MRD Testing for NAC Monitoring in TNBC

Recruiting

• Conditions: TNBC - Triple-Negative Breast Cancer; Minimal Residual Disease

• Registration Number: NCT06230185
• Lead Sponsor: Personalis Inc.

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.

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 Timeline

• Study Start: 2023-11-09
• Study First Submitted: 2024-01-09
• Study First Submitted QC: 2024-01-18
• Study First Posted: 2024-01-30
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-03
• Last Update Posted: 2025-01-07
• Primary Completion: 2025-08-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 422

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate the correlation of MRD to pCR after NAC in TNBC	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.

Secondary Outcome Measures

Name	Time	Method
Evaluate the trajectory of changes in MRD to pCR or non pCR in TNBC	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).

Trial Locations

Locations (14)

Comprehensive Hematology Oncology (ONare Alliance, LLC / Exigent Research, LLC; 🇺🇸 St. Petersburg, Florida, United States

Illinois Cancer Care; 🇺🇸 Peoria, Illinois, United States

Louisiana State University; 🇺🇸 New Orleans, Louisiana, United States

Trinity Health-Michigan; 🇺🇸 Ypsilanti, Michigan, United States

Nebraska Methodist; 🇺🇸 Omaha, Nebraska, United States

Stony Brook University Cancer Center; 🇺🇸 Stony Brook, New York, United States

Oregon Oncology Specialists; 🇺🇸 Salem, Oregon, United States

Cancer Care Associates of York; 🇺🇸 York, Pennsylvania, United States

The University of Texas MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Cancer Care Northwest; 🇺🇸 Spokane, Washington, United States

Arizona Oncology; 🇺🇸 Tucson, Arizona, United States

University of Colorado Cancer Center; 🇺🇸 Aurora, Colorado, United States

George Washington University; 🇺🇸 Washington DC, District of Columbia, United States

Mount Sinai Medical Center of Florida; 🇺🇸 Miami Beach, Florida, United States