ctDNA Positive Patients Diagnosed With cT1bN0 and cT1cN0 TNBC

A Proportion of ctDNA Positive Patients Diagnosed With cT1bN0 and cT1cN0 TNBC (ARES)

This translational biomarker study will collect blood in patients Stage I triple negative breast cancer at diagnosis prior to either neoadjuvant treatment or surgery and then during treatment.

Study Overview

• Status: Recruiting
• Conditions: Triple Negative Breast Cancer

Detailed Description

A highly sensitive, tumor-informed method of detecting circulating free DNA (cfDNA) shed by solid tumors has been developed. Plasma will be assayed for ctDNA using the SaferSeqS tumor-informed assay employing DNA sequences derived from breast biopsies and/ or surgery specimens. The abundance and molecular characteristics of ctDNA will be evaluated in 77 patients using optimum Simon Stage II statistical design.

• Study Type: Observational
• Enrollment (Estimated): 77

Contacts and Locations

• Study Contact: Name: Kelsey Mitch, BSN; Phone Number: 4126412357; Email: adamikka2@upmc.edu
• Study Contact Backup: Name: Lucia M Borrasso, BSN; Phone Number: 4126413304; Email: borrlm@upmc.edu

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15232
      • Recruiting
      • UPMC Hillman Cancer
      • Contact: Kelsey Mitch, BSN; Phone Number: 4126412357; Email: adamikka2@upmc.edu
      • Contact: Lucia M Borrasso, BSN; Phone Number: 412-641-3304; Email: borrlm@upmc.edu
      • Principal Investigator: Marija Balic, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with Stage I triple negative breast cancer at diagnosis prior to either neoadjuvant treatment or surgery and then during treatment.

Description

Inclusion Criteria:

1. Patients must be ≥18 years of age

2. Cytologically or histologically confirmed and previously untreated invasive breast cancer that is:

   • Clinical stage I
   • ≤2 cm on imaging
   • cN0
   • cM0
   • Grade 2 or Grade 3
3. ECOG 0-2
4. Locally assessed ER+ in 0% of cells.
5. Locally assessed HER2-negative (IHC 2+/FISH-negative or IHC 0 or 1+ /either FISH-negative or untested).
6. No prior chemotherapy
7. Fit for chemotherapy and surgery
8. Must have the ability to understand and the willingness to sign a written informed consent document.
9. Must be willing to provide serial blood samples for the study.

Exclusion Criteria:

1. History of other invasive malignancy in the past 2 years
2. Synchronous breast cancers and multifocal/multicentric breast cancers
3. Medical condition or social situation that may preclude adherence to the protocol.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ctDNA detection	Detection of ctDNA by assay in blood collected prior to radical prostatectomy using the Vogelstein lab assay. This assay is a highly sensitive, tumor-informed method of detecting circulating free DNA (cfDNA) shed by solid tumors. This assay has shown prognostic value for recurrence and predictive for benefit of adjuvant chemotherapy.	Up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ctDNA clearing	Percentage of patients clearing the ctDNA during neoadjuvant treatment.	Up to 2 years
pCR rate	pCR rate (ypT0/is) - All mutations per patient tested in one multiplex PCR reaction containing primers for all 96 mutations. This approach allows the detection of as few as one mutant molecule shed from tumor cells into the circulation per hour, and this detection is sufficient to engender high confidence that the patient has residual disease.	Up to 2 years
ctDNA after surgery treatment	Percentage of patients with ctDNA after surgery and all treatment.	Up to 2 years
Event free survival (EFS)	Length of time after primary treatment that the patient remains free of related complications or events.	Up to 2 years
Invasive disease-free survival (IDFS)	Time until the first occurrence of invasive breast cancer recurrence, distant recurrence, or death from any cause.	Up to 2 years

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Investigators: Principal Investigator: Marija Balic, MD, UPMC Hillman Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2026
• Primary Completion (Estimated): January 20, 2029
• Study Completion (Estimated): January 20, 2029

Study Registration Dates

• First Submitted: December 30, 2025
• First Submitted That Met QC Criteria: December 30, 2025
• First Posted (Actual): January 12, 2026

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: ctDNA
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms; Skin and Connective Tissue Diseases; Triple Negative Breast Neoplasms
• Other Study ID Numbers: HCC 25-105

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No