NCT07332975 ctDNA Positive Patients Diagnosed With cT1bN0 and cT1cN0 TNBC
| NCT ID | NCT07332975 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Pittsburgh |
| Condition | Triple Negative Breast Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 77 participants |
| Start Date | 2026-01-20 |
| Primary Completion | 2029-01-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 77 participants in total. It began in 2026-01-20 with a primary completion date of 2029-01-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Marija Balic, MD
PRINCIPAL INVESTIGATOR
UPMC Hillman Cancer Center
Frequently Asked Questions
Who can join the NCT07332975 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Triple Negative Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07332975 currently recruiting?
Yes, NCT07332975 is actively recruiting participants. Contact the research team at adamikka2@upmc.edu for enrollment information.
Where is the NCT07332975 trial being conducted?
This trial is being conducted at Pittsburgh, United States.
Who is sponsoring the NCT07332975 clinical trial?
NCT07332975 is sponsored by University of Pittsburgh. The principal investigator is Marija Balic, MD at UPMC Hillman Cancer Center. The trial plans to enroll 77 participants.
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