CClinicalTrials.gg
Sign In
RecruitingNCT07332975Updated May 1, 2026

ctDNA Positive Patients Diagnosed With cT1bN0 and cT1cN0 TNBC

An observational study in Triple Negative Breast Cancer, sponsored by University of Pittsburgh. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-01.

Sponsored by University of Pittsburgh · Observational

From the registry’s dates

  • Started Jan 2026; still recruiting 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
77
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Triple Negative Breast Cancer

Keywords

  • ctDNA
03

In context

Triple Negative Breast Neoplasms

1,140 studies on the registry are indexed under Triple Negative Breast Neoplasms; 443 are open to participants now.

This study's planned enrollment of 77 is below the median of 186 across 103 observational studies indexed under Triple Negative Breast Neoplasms.

Browse Triple Negative Breast Neoplasms studies →

Lead sponsor

University of Pittsburgh is the lead sponsor of 1,385 studies on the registry; 167 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
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.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
77 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna
06

What researchers measure

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.

    Time frame: Up to 2 years

Secondary outcomes

  1. ctDNA clearing

    Percentage of patients clearing the ctDNA during neoadjuvant treatment.

    Time frame: Up to 2 years

  2. 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.

    Time frame: Up to 2 years

  3. ctDNA after surgery treatment

    Percentage of patients with ctDNA after surgery and all treatment.

    Time frame: Up to 2 years

  4. Event free survival (EFS)

    Length of time after primary treatment that the patient remains free of related complications or events.

    Time frame: Up to 2 years

  5. Invasive disease-free survival (IDFS)

    Time until the first occurrence of invasive breast cancer recurrence, distant recurrence, or death from any cause.

    Time frame: Up to 2 years

07

Study locations

1 of 1 sites recruiting
  • UPMC Hillman Cancer
    Pittsburgh, Pennsylvania 15232, United States
    • Kelsey Mitch, BSN · Contact · adamikka2@upmc.edu · 4126412357
    • Lucia M Borrasso, BSN · Contact · borrlm@upmc.edu · 412-641-3304
    • Marija Balic, MD · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07332975
Lead sponsor
University of Pittsburgh
Responsible party
Marija Balic, MD PhD (Professor of Medicine, Hematology Oncology, University of Pittsburgh) — Principal investigator
First posted
Jan 12, 2026
Start date
Jan 20, 2026
Primary completion
Jan 20, 2029 (estimated)
Completion
Jan 20, 2029 (estimated)
Last update
May 1, 2026

Study contacts

Kelsey Mitch, BSN
Contact
adamikka2@upmc.edu
4126412357
Lucia M Borrasso, BSN
Contact
borrlm@upmc.edu
4126413304
Marija Balic, MD
principal investigator · UPMC Hillman Cancer Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Triple Negative Breast Neoplasms→

Other studies from this sponsor

University of Pittsburgh

Start the discussion