This study is a multicenter, randomized controlled phase III clinical trial. The aim of this study is to observe the efficacy and safety of PD-1 inhibitors combined with capecitabine, PD-1 inhibitors alone, or capecitabine alone in patients with TNBC who have residual lesions after neoadjuvant treatment.
The subjects will be randomly assigned in a 1:1:1 ratio to Group A (capecitabine combined with PD-1 inhibitor), Group B (PD-1 inhibitor), and Group C (capecitabine). The stratification factors are the lymph node metastasis status (lymph node metastasis negative ypN0, lymph node metastasis positive ypN1-3) and PD-L1 status (negative/positive) after neoadjuvant treatment.
Group A: Capecitabine, 1250mg/m2, twice a day, 14/21 days, combined with PD-1 inhibitor, for a total of 8 cycles Group B: PD-1 inhibitor, for a total of 8 cycles Group C: Capecitabine, 1250mg/m2, twice a day, 14/21 days, for a total of 8 cycles The study will include approximately 10 centers. After the completion of NAT (chemotherapy + immunotherapy), 852 patients with residual lesions (breast still has invasive cancer lesions remaining and/or positive axillary lymph nodes) will be enrolled, with 284 patients in each of Groups A, B, and C. After surgery, clinicians will, based on clinical treatment guidelines and the clinical practices of each center, administer radiotherapy to subjects with indications for radiotherapy.
During radiotherapy, the use of capecitabine and/or immunotherapy is decided by the supervising doctor as either concurrent or sequential.
Tumor stage: II-IIIc, without internal mammary lymph node and supraclavicular lymph node metastasis
HER2 negative: defined as IHC 0 or IHC 1+ or IHC 2+ and FISH -7 / 32
Estrogen receptor (ER) and progesterone receptor (PR) negative: <1%.
Hemoglobin (HB) ≥ 90g/L;
History of congestive heart failure or systolic dysfunction (LVEF < 50%);
Angina pectoris requiring anti-anginal drugs;
High-risk uncontrolled arrhythmias or severe conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, second- to third-degree atrioventricular block, etc.; average QTcF > 470ms during rest;
Cardiac valve disease with cardiac dysfunction;
Parallel
Capecitabine and PD-1 inhibitor
DrugGroup A: Capecitabine, 1250mg/m\^2, twice a day, 14/21 days, combined with PD-1 inhibitor, for a total of 8 cycles
PD-1 inhibitor
DrugGroup B:PD-1 inhibitor, 8 treatment cycles in total
Capecitabine
DrugGroup C:Capecitabine, 1250mg/m\^2, twice a day, 14/21 days, a total of 8 cycles
The DFS (Disease-Free Survival) of patients randomly assigned to group A (capecitabine combined with PD-1 inhibitor), group B (PD-1 inhibitor) and group C (capecitabine) at the time of enrollment was compared
DFS was defined as the time from randomization to the first occurrence of any of the following events: 1) recurrence of breast cancer with ipsilateral chest wall and regional lymph node involvement; 2) distant metastasis (confirmed by histology or clinically diagnosed); 3) death related to breast cancer, unrelated to breast cancer, or with unknown cause; 4) recurrence of breast cancer on the opposite side.
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