National Cancer Center Singapore, Singapore.
Princess Margaret Cancer Centre/UHN, Toronto, ON, Canada.
Future Oncol. 2023 Nov;19(35):2349-2359. doi: 10.2217/fon-2023-0228. Epub 2023 Aug 1.
Despite recent treatment advances, the prognosis for patients with locally recurrent inoperable or metastatic triple-negative breast cancer (TNBC) remains poor. The antibody-drug conjugate datopotamab deruxtecan (Dato-DXd) is composed of a humanized anti-TROP2 IgG1 monoclonal antibody linked to a topoisomerase I inhibitor payload via a stable, cleavable linker. The phase III TROPION-Breast02 trial in patients previously untreated for locally recurrent inoperable or metastatic TNBC, who are not candidates for PD-1/PD-L1 inhibitors is evaluating efficacy and safety of Dato-DXd versus investigator's choice of chemotherapy (ICC). Approximately 600 patients will be randomized 1:1 to Dato-DXd 6 mg/kg iv. every 3 weeks or ICC (paclitaxel, nab-paclitaxel, carboplatin, capecitabine or eribulin mesylate). Dual primary end points are progression-free survival by blinded independent central review and overall survival.
尽管最近的治疗进展，局部复发性不可切除或转移性三阴性乳腺癌（TNBC）患者的预后仍然很差。抗体药物偶联物 datopotamab deruxtecan（Dato-DXd）由与人 TROP2 IgG1 单克隆抗体通过稳定的可裂解接头连接的拓扑异构酶 I 抑制剂有效载荷组成。在先前未接受局部复发性不可切除或转移性 TNBC 治疗、不适合 PD-1/PD-L1 抑制剂的患者中进行的 III 期 TROPION-Breast02 试验正在评估 Dato-DXd 与研究者选择的化疗（ICC）的疗效和安全性。大约 600 名患者将按 1:1 的比例随机分配至 Dato-DXd 6mg/kg iv. 每 3 周一次或 ICC（紫杉醇、白蛋白紫杉醇、卡铂、卡培他滨或甲磺酸艾立布林）。双重主要终点是盲法独立中心审查的无进展生存期和总生存期。
