Tumor-informed ctDNA testing for people with small, early-stage triple-negative breast cancer
A Proportion of ctDNA Positive Patients Diagnosed With cT1bN0 and cT1cN0 TNBC (ARES)
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 |
|---|---|
| Enrollment | 77 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Pittsburgh Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT07332975 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Pittsburgh, Pennsylvania
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.