Camrelizumab plus apatinib and chemotherapy as neoadjuvant therapy for triple negative breast cancer (TNBC): A single-arm, prospective phase II study (MA-BC-II-026).

e12623 Background: Triple-negative breast cancer (TNBC) is a subtype of breast cancer characterized by poor prognosis and limited treatment options due to the lack of targeted therapies. Chemotherapy is the standard treatment for TNBC, but its efficacy remains unsatisfactory. Recent advances in immunotherapy have shown promise in improving treatment outcomes. This study aimed to evaluate the clinical efficacy and safety of camrelizumab, an anti-PD-1 antibody, combined with apatinib and chemotherapy as neoadjuvant therapy in patients with stage II-III TNBC. Methods: In this single-center, prospective, non-randomized clinical trial, patients with newly diagnosed stage II-III TNBC in West China Hospital received a combination of camrelizumab (200 mg intravenouly every 2 weeks), apatinib (250 mg orally daily), and alternating chemotherapy (4 cycles of albumin paclitaxel and 4 cycles of epirubicin plus cyclophosphamide) for 8 cycles. The primary endpoint was pathological complete response (pCR), and secondary endpoints included overall response rate (ORR), and treatment-related adverse events (AEs). Results: A total of 35 patients were enrolled from June 2023 to April 2024, of which one patient withdrew from the study due to intolerance to adverse reactions. At the end of the treatment, the total pCR (ypT0/is ypN0) rate was 67.6% (23/34), and the bpCR (ypT0/is) rate was 70.6% (24/34). The tpCR rate of PD-L1 positive subgroup was higher than that of PD-L1 negative group (66.7% vs. 50.0%). The ORR at the end of neoadjuvant treatment was 94.1% (32/34). The most common grade 3-4 adverse events were elevated levels of alanine aminotransferase (38.2%) and aspartate aminotransferase (29.4%), and no significant toxicities or treatment-related deaths were observed. Conclusions: Camrelizumab and apatinib combined with chemotherapy as neoadjuvant treatment for stage II-III TNBC has high clinical efficacy and favorable safety, which is worthy of further investigation and clinical application. Clinical trial information: NCT05447702 .