NCT07332975Recruiting
ctDNA Positive Patients Diagnosed With cT1bN0 and cT1cN0 TNBC
A Proportion of ctDNA Positive Patients Diagnosed With cT1bN0 and cT1cN0 TNBC (ARES)
Source: ClinicalTrials.gov · Last updated 1 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 77 (estimated)
- First submitted
- 30 Dec 2025
- Start date
- 20 Jan 2026
- Primary completion date
- 20 Jan 2029
- Lead sponsor
- University of Pittsburgh
- Diseases
- Triple-negative breast cancer
- NCT number
- NCT07332975
What you commit to
- Study type: Observational
- Planned participants: 77
- From 20 Jan 2026 to the primary completion date, 20 Jan 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UPMC Hillman Cancer Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.