ctDNA Positive Patients Diagnosed With cT1bN0 and cT1cN0 TNBC

NCT07332975 | Recruiting DMC

• 1 other identifier: HCC 25-105
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Triple Negative Breast Cancer

Keywords

ctDNA

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• ctDNA clearing

  Up to 2 years

• pCR rate

  Up to 2 years

• ctDNA after surgery treatment

  Up to 2 years

• Event free survival (EFS)

  Up to 2 years

• Invasive disease-free survival (IDFS)

  Up to 2 years

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients must be ≥18 years of age
• 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
• ECOG 0-2
• Locally assessed ER+ in 0% of cells.
• Locally assessed HER2-negative (IHC 2+/FISH-negative or IHC 0 or 1+ /either FISH-negative or untested).
• No prior chemotherapy
• Fit for chemotherapy and surgery
• Must have the ability to understand and the willingness to sign a written informed consent document.
• Must be willing to provide serial blood samples for the study.

You may not qualify if:

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

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

UPMC Hillman Cancer

Pittsburgh, Pennsylvania, 15232, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

circulating free DNA (cfDNA); paired tumor and matched WBC whole genome sequencing

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Marija Balic, MD

  UPMC Hillman Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kelsey Mitch, BSN

CONTACT

4126412357; adamikka2@upmc.edu

Lucia M Borrasso, BSN

CONTACT

4126413304; borrlm@upmc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Hematology Oncology

Study Record Dates

• First Submitted: December 30, 2025
• First Posted: January 12, 2026
• Study Start: January 20, 2026
• Primary Completion (Estimated): January 20, 2029
• Study Completion (Estimated): January 20, 2029
• Last Updated: May 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)