ctDNA Positive Patients Diagnosed With cT1bN0 and cT1cN0 TNBC
NCT ID: NCT07332975
Last Updated: 2026-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
77 participants
OBSERVATIONAL
2026-01-31
2029-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
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
2. Synchronous breast cancers and multifocal/multicentric breast cancers
3. Medical condition or social situation that may preclude adherence to the protocol.
18 Years
FEMALE
No
Sponsors
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University of Pittsburgh
OTHER
Responsible Party
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Marija Balic, MD PhD
Professor of Medicine, Hematology Oncology
Principal Investigators
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Marija Balic, MD
Role: PRINCIPAL_INVESTIGATOR
UPMC Hillman Cancer Center
Locations
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UPMC Hillman Cancer
Pittsburgh, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HCC 25-105
Identifier Type: -
Identifier Source: org_study_id
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