A Phase 2, Multicenter, Open-Label Study of Trastuzumab Deruxtecan (DS-8201a), anAnti-HER2-Antibody Drug Conjugate (ADC) for HER2-Positive,Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated with T-DM1. - DS8201-A-U201

Daiichi Sankyo Inc.0 个研究点目标入组 253 人开始时间: 2017年10月19日最近更新: 2021年1月5日

适应症

试验速览

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•Men or women the age of majority in their country
•Has pathologically documented breast cancer that:
•1.is unresectable or metastatic
•2.has HER2 positive expression confirmed per protocol
•Has an adequate tumor sample
•Has at least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
•Has protocol-defined adequate cardiac, renal and hepatic function
•Agrees to follow protocol-defined method(s) of contraception
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 207
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 23

•Has a medical history of myocardial infarction, symptomatic congestive heart failure (CHF) (NYHA classes II-IV), unstable angina or serious cardiac arrhythmia
•Has a QTc prolongation to > 450 millisecond (ms) in males and > 470 ms in females
•Has a medical history of clinically significant lung disease
•Is suspected to have certain other protocol-defined diseases based on imaging at screening period
•Has history of any disease, metastatic condition, drug/medication use or other condition that might, per protocol or in the opinion of the investigator, compromise:
•1.safety or well-being of the participant or offspring
•2.safety of study staff
•3.analysis of results

发起方