Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Age
18–80
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Must have histologically or cytologically confirmed triple negative (ER-/PR-/HER2-) invasive breast cancer, clinical stage II-III at diagnosis (AJCC 6th edition) based on initial evaluation by physical examination and/or breast imaging prior to study registration.ER and PR will be considered negative if ≤ 1% of cells stain weakly positive. HER2 will be considered negative if scored 0 or 1+ by immunohistochemistry (IHC) or 2+ by IHC associated with a fluorescence in situ hybridization (FISH) ratio of \< 2.0 or \< 6 copies per cell.
Must receive preoperative (neoadjuvant) chemotherapy. NOTE: Acceptable preoperative regimens include those recommended by NCCN guidelines. Participants who received preoperative therapy as part of a clinical trial may enroll.
ctDNA positive at baseline, after NAC or after surgery
Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
Written informed consent to provide research blood samples and tumor samples
Patients must be willing to have frequent blood tests (every 3 months ) and receive a 12 month course of tislelizumab if randomised to tislelizumab treatment on ctDNA detection
No evidence of distant metastatic disease on staging scans conducted at the time of diagnosis
You may not be if
Previously participated in other interventional trials
Previous malignancy within 3 years of breast cancer diagnosis
Pregnancy or breastfeeding
No written consent
Unable to receive standard NAC and subsequent radiotherapy(if needed)
Active autoimmune disease
Clareo Health | A Prospective, Phase II Trial Using ctDNA to Initiate Post-operation Boost Therapy After NAC in TNBC
