Dataset from A Multicenter Phase I Open-label Dose-escalation Vaccine Trial of dHER2 Protein With AS15 Adjuvant in HER2-overexpressing Patients With High-risk Breast Cancer

Treatment phase: The purpose of this study is to evaluate the safety and the immune response elicited by a new anti-cancer therapy in patients with breast cancer in remission but who are at high risk of relapse. The study product is an immunotherapeutic consisting of the recombinant dHER2 protein combined with an immunostimulant called AS15. The study aims to determine the optimal of three different dose levels of dHER2 combined with the same fixed dose of AS15 by assessing the safety and the immune response elicited after a series of injections of the study product. Five-year follow-up phase: This part of the study aims to assess any late onset toxicity of the study treatment through yearly follow-up visits and to monitor the patients' survival and disease status up to five years after the last administration of the study treatment. The patients' immune response is also measured to assess the robustness of the immune response elicited by the study treatment.

治疗阶段：本研究旨在评估一款新型抗癌疗法在处于临床缓解期但复发风险较高的乳腺癌患者中的安全性与诱导产生的免疫应答。研究产品为重组dHER2蛋白联合名为AS15的免疫刺激剂组成的免疫治疗药物。本研究拟通过评估系列给药后研究产品诱导产生的安全性与免疫应答，确定三种不同dHER2剂量水平联合固定剂量AS15的最优给药剂量。五年随访阶段：本部分研究旨在通过年度随访访视评估研究治疗的迟发性毒性，并监测末次给药后长达五年的患者生存状况与疾病状态，同时检测患者的免疫应答，以评估该疗法诱导产生的免疫应答的稳健性。