Clinical trial · Observational
ctDNA Positive Patients Diagnosed With cT1bN0 and cT1cN0 TNBC
A Proportion of ctDNA Positive Patients Diagnosed With cT1bN0 and cT1cN0 TNBC (ARES)
NCT07332975CI-TRIAL-00110031recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Triple Negative Breast Cancer | Triple-Negative Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- ctDNA detection
- timeFrame
- Up to 2 years
- description
- 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.
Secondary outcomes (5)
- measure
- ctDNA clearing
- timeFrame
- Up to 2 years
- description
- Percentage of patients clearing the ctDNA during neoadjuvant treatment.
- measure
- pCR rate
- timeFrame
- Up to 2 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.