Phase II clinical trial of PD-L1 in combination with vinorelbine + cyclophosphamide + capecitabine (VEX) metronomic chemotherapy with or without radiotherapy for advanced triple-negative breast cancer.
Male or female who is 18 years of age or older on the day of signing the informed consent form.
Subjects with metastatic triple-negative breast cancer, with clear clinical data records; specific reference to the "American Society of Clinical Oncology - College of American Pathologists (ASCO/CAP) guidelines."
Have received less than or equal to 1 line of chemotherapy for metastatic breast cancer;
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 as assessed within 10 days before the start of study treatment;
None
Parallel
Adebrelimab + VEX metronomic chemotherapy + radiotherapy
Drug1、Adebrelimab: 1200mg on day 1, every 3 weeks； 2、VEX Metronomic Chemotherapy: Vinorelbine 20mg orally, once every other day, Q3W Cyclophosphamide 50mg orally, once daily, Q3W Capecitabine 500mg orally, three times daily, Q3W
Adebrelimab + VEX metronomic chemotherapy
Drug1、Adebrelimab: 1200mg on day 1, every 3 weeks； 2、VEX Metronomic Chemotherapy: Vinorelbine 20mg orally, once every other day, Q3W Cyclophosphamide 50mg orally, once daily, Q3W Capecitabine 500mg orally, three times daily, Q3W
Progression-Free Survival
According to RECIST 1.1 criteria：Disease Progression (PD): Referring to the smallest sum of the diameters of all measured target lesions throughout the entire experimental study, there is a relative increase of at least 20% in the sum of the diameters (if the baseline measurement is the smallest, then the baseline value is used as the reference); in addition, there must be an absolute increase of at least 5 mm in the sum of the diameters (the appearance of one or more new lesions is also considered disease progression).
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