Abstract PO1-03-11: Camrelizumab in Combination with Nab-Paclitaxel and Carboplatin versus Nab-Paclitaxel and Carboplatin as Neoadjuvant Therapy for Triple Negative Breast Cancer: A Multicenter, Open-Label, Randomized Controlled Study

Abstract Background: Triple-negative breast cancer (TNBC) is recognized for its aggressive nature and unfavorable prognosis. Immune checkpoint inhibitors have demonstrated promising antitumor activity in both neoadjuvant and metastatic settings. This study aimed to assess the efficacy and safety of camrelizumab, an anti-PD-1 antibody, in conjunction with chemotherapy as a neoadjuvant treatment for early-stage TNBC. Methods: This two-phase prospective, multicenter, randomized controlled study was initiated with the enrollment of previously untreated stage II-III TNBC patients in the first phase. They received neoadjuvant therapy comprising six 3-week cycles of camrelizumab (200 mg, q3w), along with nab-paclitaxel (220 mg/m2, q3w) and carboplatin (AUC 5, q3w). In the second phase, patients were enrolled and randomized 1:1 to either the camrelizumab plus nab-paclitaxel and carboplatin group or the nab-paclitaxel plus carboplatin group. The present report covers the data from the first phase of the study. The primary endpoint was the total pathological complete response (tpCR, ypT0/is ypN0) rate. Secondary endpoints included breast pathological complete response (bpCR, ypT0/is) rate, objective response rate (ORR), event-free survival (EFS), residual cancer burden (RCB), and safety. This study is registered with ClinicalTrials.gov, under the identifier NCT04907344. Results: Between September 2021 and March 2023, 39 patients were enrolled in the first phase. A total of 35 (89.7%) were node-positive. Among the 32 patients with evaluable efficacy, the tpCR rate was 59.4% (19/32), and the bpCR rate was 68.8% (22/32). The ORR at the end of neoadjuvant treatment stood at 87.2% (34/39). Among the 39 patients, 11 (28.2%) experienced grade 3 or higher treatment-related adverse events, the most common of which were thrombocytopenia (6 15.4%), leucopenia (5 12.8%), neutropenia (5 12.8%), alanine aminotransferase increased (2 5.1%), aspartate aminotransferase increased (1 2.6%), and hypothyroidism (1 2.6%). Adverse events leading to discontinuation of any agent occurred in 5 (12.8%) patients, while adverse events leading to delay in treatment occurred in 7 (17.9%) patients. Serious treatment-related adverse events were reported by 4 (10.4%) patients. Conclusions: In patients with early TNBC, the neoadjuvant treatment of camrelizumab in combination with nab-paclitaxel and carboplatin demonstrated a high pCR rate with an acceptable safety profile. The second phase of the study is currently in progress to validate these findings. Citation Format: Weipeng Zhao, Xin Wang, Bin Zhang, Yehui Shi, Chen Wang, Xu Wang, Shufen Li, Chunfang Hao, Ning Lu, Yongsheng Jia, Li Zhang, Lan Zhang, Weixin Sun, Xuchen Cao, Zhongsheng Tong. Camrelizumab in Combination with Nab-Paclitaxel and Carboplatin versus Nab-Paclitaxel and Carboplatin as Neoadjuvant Therapy for Triple Negative Breast Cancer: A Multicenter, Open-Label, Randomized Controlled Study abstract. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO1-03-11.