Breast Cancer-Minimal/Molecular Residual Disease Detection and Therapy Monitoring in Patients with Early Stage TNBC-Phase I (B-STRONGER-I)
A prospective, multicenter, observational study to evaluate the correlation of Molecular Residual Disease (MRD) detection using circulating tumor DNA guided test to pathological complete response (pCR) after neoadjuvant chemotherapy (NAC) in stage I-III triple negative breast cancer (TNBC). Results from this study aim to improve MRD detection and disease outcomes for future patients.
• Have histologically documented TNBC (defined as ER expression ≤10% by IHC, PR expression≤10% by IHC and HER2 0 or 1+ by IHC or FISH ratio \<2 or HER2 gene copy number of \<6).
• Early-stage breast cancer (stage I-III) and scheduled to undergo NAC treatment with curative intent.
• Be informed of the investigational nature of the study and all pertinent aspects of the trial.
• Have the ability to understand and the willingness to sign a written informed consent document in accordance with institutional and federal guidelines.
• Be ≥ 18years of age.
• Patient who are scheduled to start NAC.
• Be willing to provide blood samples before and during treatment.
• Have available biopsy tissue.