ctDNA Positive Patients Diagnosed With cT1bN0 and cT1cN0 TNBC
Recruiting · NCT07332975 · Observational (researchers observe without assigning treatment) · Lead sponsor: University of Pittsburgh
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Where it is running
1 location listed across 1 US state.
- UPMC Hillman Cancer - Pittsburgh, Pennsylvania, United States