Positive circulating tumor DNA(ctDNA) status is associated with worse prognosis in breast cancer, especially triple-negative breast cancer(TNBC). Our trial aims to improve the outcome of TNBC patients by using ctDNA to identify patients with high relapse risk. ctDNA positive patients will be randomized to receive boost therapy or standard therapy indicated in NCCN guidelines after NAC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
460
200mg, q3w, for 1 year
600-750 mg/m2 PO Bid,continuous, for 1 year
Sunyat-sen Memorial Hospital
Guandong, Guangdong, China
RECRUITING5 years Disease free survival(DFS)
From diagnosis to 5yrs or DFS events; To determine 5-year disease free survival in ctDNA positive participants with confirmed triple negative breast cancer (TNBC) treated with a boost therapy or standard of care following preoperative chemotherapy
Time frame: 60 months
5 years overall survival(OS)
From diagnosis to 5yrs or death; To determine 5-year overall survival in ctDNA positive participants with confirmed triple negative breast cancer (TNBC) treated with a boost therapy or standard of care following preoperative chemotherapy
Time frame: 60 months
pathological complete remission(pCR) rate
pathological complete remission
Time frame: 12 months
brain metastasis rate
The percentage of patients who develop brain metastasis
Time frame: 60 months
objective response rate(ORR)
The percentage of patients who achieved PR+CR
Time frame: 12 months
Number of Patients with Adverse Events as a Measure of Safety and Tolerability
To determine the toxicities associated with tislelizumab in this population
Time frame: 12 months
10 years DFS
To determine 10-year disease free survival in ctDNA positive participants with confirmed triple negative breast cancer (TNBC) treated with a boost therapy or standard of care following preoperative chemotherapy
Time frame: 120 months
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10 years OS
To determine 10-year overall survival in ctDNA positive participants with confirmed triple negative breast cancer (TNBC) treated with a boost therapy or standard of care following preoperative chemotherapy
Time frame: 120 months
Relapse and metastasis rate
The percentage of patients who develop brain metastasis any relapse or metastasis
Time frame: 24 months