A Phase II, Open-Label Study to Evaluate Corrected QT Interval Effects of Trastuzumab-MCC-DM1 (T-DM1) in Patients With HER2-Positive Locally Advanced or Metastatic Breast Cancer and to Evaluate the Safety and Tolerability of Combined T-DM1 and Pertuzumab in Patients With Early Disease Progression While Receiving T-DM1 Alone

This is a multicenter, open-label, single-arm Phase II study designed to evaluate the effect of T-DM1 on the duration of corrected QT (QTc) interval in patients with HER2-positive locally advanced or metastatic breast cancer and to make preliminary assessments regarding the safety, tolerability, and efficacy of combined T-DM1 and pertuzumab in patients with early disease progression. The QT interval is a measure of time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. The QTcF interval is the QT interval as calculated using Fridericia's correction; the QTcB interval is the QT interval as calculated using Bazett's correction.

本研究为一项多中心、开放标签、单臂II期临床试验，旨在评估T-DM1对人类表皮生长因子受体2（HER2）阳性局部晚期或转移性乳腺癌患者校正QT（QTc）间期时长的影响，并针对发生早期疾病进展的患者，对T-DM1联合帕妥珠单抗（pertuzumab）治疗的安全性、耐受性及疗效进行初步评估。
QT间期是指心脏电周期中Q波起始至T波终止的时间跨度。
QTcF间期为采用弗里德西卡（Fridericia）校正法计算得到的QT间期；QTcB间期为采用巴泽特（Bazett）校正法计算得到的QT间期。