ctDNA Positive Patients Diagnosed With cT1bN0 and cT1cN0 TNBC

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

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.

Conditions3

Locations1 site

Browse More Trials