Tumor-informed ctDNA testing for people with small, early-stage triple-negative breast cancer
Official title: A Proportion of ctDNA Positive Patients Diagnosed With cT1bN0 and cT1cN0 TNBC (ARES)
Run by University of Pittsburgh · NCT07332975 · Data updated 2026-11-12
This project will test whether a highly sensitive tumor-informed blood test (ctDNA) can detect tumor DNA in people newly diagnosed with small, stage I triple-negative breast cancer before and during their treatment.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 77 (estimated) |
| Sponsor | University of Pittsburgh Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Status | Recruiting |
| Started | January 20, 2026 |
| Main results expected | January 20, 2029 |
| Study ends | January 20, 2029 |
| Registry record updated | May 1, 2026 |
| Trial ID | NCT07332975 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with newly diagnosed, treatment-naive clinical stage I (≤2 cm), node-negative, ER 0%, HER2-negative, grade 2 or 3 triple-negative breast cancer who are fit for chemotherapy and surgery and willing to provide serial blood samples are ideal candidates.
✕Probably not a fit
Patients with a recent other invasive malignancy, synchronous or multifocal breast cancers, more advanced or node-positive disease, inability to provide serial blood samples, or medical/social situations that prevent protocol adherence are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational translational biomarker study will collect serial blood samples from 77 patients with clinical stage I triple-negative breast cancer at diagnosis and during treatment, either prior to neoadjuvant therapy or around the time of surgery. Tumor biopsy or surgical specimens will provide tumor-specific DNA sequences that are used to create a personalized SaferSeqS assay for each patient. Plasma samples will be assayed for circulating tumor DNA (ctDNA) and analyzed for abundance and molecular characteristics over time. An optimal Simon two-stage statistical design will be used to determine whether ctDNA is detected at rates suggesting potential clinical utility in this very early-stage population.
Why it matters
Potential benefit: If successful, this could help detect residual disease or early treatment response in stage I TNBC and support more personalized follow-up or therapy decisions.
How similar studies have gone: Tumor-informed ctDNA assays such as SaferSeqS have shown promising sensitivity in other cancers and in higher-stage breast cancer, but applying them to very early stage I TNBC is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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UPMC Hillman Cancer
Pittsburgh, Pennsylvania, United States Recruiting
Study contacts
- Principal investigator: Marija Balic, MD — UPMC Hillman Cancer Center
- Study coordinator: Kelsey Mitch, BSN
- Email: adamikka2@upmc.edu
- Phone: 4126412357
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.