Recruiting

Observational Study

Sponsor:

University of Pittsburgh

Code:

NCT07332975

Conditions

Triple Negative Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT07332975

Start date

Jan 20, 2026

Status verified date

Mar, 2026

Completion date

Jan 20, 2029

Anticipated

Primary completion date

Jan 20, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

77 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • ctDNA detection [ Time Frame: Up to 2 years ]

Central Contacts and Locations

Central contacts

Lucia M Borrasso, BSN

4126413304borrlm@upmc.edu

Locations

UPMC Hillman Cancer

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Contacts

Lucia M Borrasso, BSN

412-641-3304borrlm@upmc.edu

Principal Investigator:

Marija Balic, MD

More Information

Sponsor

University of Pittsburgh

Last update posted

May 1, 2026

Last verified

Mar, 2026

Keywords

  • ctDNA

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Pittsburgh on 2026-05-01.