ctDNA Based MRD Testing for NAC Monitoring in TNBC (B-STRONGER-I)

• ClinicalTrials.gov Identifier: NCT06230185
• Recruitment Status: Recruiting
• First Posted: January 30, 2024
• Last Update Posted: January 30, 2024
• Sponsor: Personalis Inc.
• Information provided by (Responsible Party): Pavani Chalasani, George Washington University

Tracking Information

• First Submitted Date: January 9, 2024
• First Posted Date: January 30, 2024
• Last Update Posted Date: January 30, 2024
• Actual Study Start Date: November 9, 2023
• Estimated Primary Completion Date: August 30, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 18, 2024)

Evaluate the correlation of MRD to pCR after NAC in TNBC [ Time Frame: 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.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: January 18, 2024)

Evaluate the trajectory of changes in MRD to pCR or non pCR in TNBC [ Time Frame: 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).

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: January 18, 2024)

• Stratification based on NAC therapy regimen [ Time Frame: through study completion, an average of 6 months ]
  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.
• Evaluate genomic profiles [ Time Frame: through study completion, an average of 6 months ]
  Evaluate genomic profile for specific biomarkers during neoadjuvant chemotherapy (NAC)

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: ctDNA Based MRD Testing for NAC Monitoring in TNBC
• Official Title: Breast Cancer-Minimal/Molecular Residual Disease Detection and Therapy Monitoring in Patients With Early Stage TNBC-Phase I (B-STRONGER-I)
• 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 Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples With DNA

Description:

FFPE, DNA extracted from blood, ctDNA extracted from plasma

• Sampling Method: Non-Probability Sample
• Study Population: Female patient who are scheduled to start NAC with early-stage Triple Negative Breast Cancer.

Condition

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

• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: January 18, 2024): 422
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2025
• Estimated Primary Completion Date: August 30, 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Ruth Stone; 518 669 9232; restone@criteriuminc.com

Contact: Julee Hartwell; 607-651-6273; jhartwell@criteriuminc.com

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT06230185
• Other Study ID Numbers: 01-PS-001; B-STRONGER-I ( Other Identifier: Personalis )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Pavani Chalasani, George Washington University
• Original Responsible Party: Same as current
• Current Study Sponsor: Personalis Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Pavani Chalasani; George Washington University

• PRS Account: Personalis Inc.
• Verification Date: January 2024