ctDNA Based MRD Testing for NAC Monitoring in TNBC

Minimal Residual Disease Clinical Trial

— B-STRONGER-I  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06230185
• Other study ID #: 01-PS-001
• Secondary ID: B-STRONGER-I
• Status: Recruiting
• Start date: November 9, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2024
• Source: Personalis Inc.
• Contact: Ruth Stone
• Phone: 518 669 9232
• Email: restone[@]criteriuminc.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 422
• Est. completion date: December 31, 2025
• Est. primary completion date: August 30, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Minimal Residual Disease
• Neoplasm, Residual
• TNBC - Triple-Negative Breast Cancer
• Triple Negative Breast Neoplasms

Locations

Country	Name	City	State
United States	Alison Stopeck	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
Personalis Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Stratification based on NAC therapy regimen	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
Other	Evaluate genomic profiles	Evaluate genomic profile for specific biomarkers during neoadjuvant chemotherapy (NAC)	through study completion, an average of 6 months
Primary	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	Evaluate the trajectory of changes in MRD to pCR or non pCR in TNBC	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