[Translation] A multicenter, randomized, double-blind, parallel-controlled phase III study to evaluate the equivalence of preoperative KM118 or pertuzumab combined with trastuzumab and docetaxel in patients with early or locally advanced HER2-positive breast cancer
主要研究目的:通过组长单位中心病理评估的总体病理完全缓解率(tpCR,定义为 ypT0/is、ypN0,即切除乳腺癌样本和所有同侧淋巴结样本中,不存在任何残留的浸润癌的受试者所占比例),评价 KM118或帕妥珠单抗分别联合曲妥珠单抗、多西他赛用于早期或局部晚期 HER2 阳性,ER、PR 均为阴性乳腺癌新辅助治疗的等效性。 次要研究目的: 1. 乳腺病理学完全缓解率 bpCR:由各参研中心病理专家进行评估,指完成新辅助治疗和手术后,切除乳腺癌样本的评估中,不存在任何残留的浸润癌(即根据 AJCC 第八版分期为 ypT0/is)受试者的比例; 2. 新辅助疗程 1-6 期间的客观缓解率(ORR); 3. 保乳率; 4. 评价 KM118 药代动力学(PK)特征。 安全性研究目的:评估各治疗方案的安全性和耐受性。
免疫原性研究目的: 通过测定血清中 ADA 以及其中和抗体(Nabs)的发生率来评价 KM118 的免疫原性。
[Translation] Primary study objectives: To evaluate the equivalence of KM118 or pertuzumab combined with trastuzumab and docetaxel for neoadjuvant treatment of early or locally advanced HER2-positive, ER and PR-negative breast cancer by overall pathological complete response rate (tpCR, defined as ypT0/is, ypN0, i.e., the proportion of subjects without any residual invasive cancer in the resected breast cancer specimen and all ipsilateral lymph node specimens) assessed by the lead center pathology. Secondary study objectives: 1. Breast pathological complete response rate bpCR: assessed by pathologists at each participating center, refers to the proportion of subjects without any residual invasive cancer (i.e., ypT0/is according to the eighth edition of the AJCC staging system) in the assessment of resected breast cancer specimens after completing neoadjuvant therapy and surgery; 2. Objective response rate (ORR) during neoadjuvant courses 1-6; 3. Breast conservation rate; 4. Evaluation of the pharmacokinetic (PK) characteristics of KM118. Purpose of safety study: To evaluate the safety and tolerability of each treatment regimen.
Purpose of immunogenicity study: To evaluate the immunogenicity of KM118 by measuring the incidence of ADA and its neutralizing antibodies (Nabs) in serum.