Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Daiichi Sankyo
With
AstraZeneca
Daiichi Sankyo Co., Ltd.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
Has a medical history of myocardial infarction, symptomatic congestive heart failure (CHF) (NYHA classes II-IV), unstable angina or serious cardiac arrhythmia
Has a corrected QT interval (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
Clareo Health | A Study of DS-8201a in Metastatic Breast Cancer Previously Treated With Trastuzumab Emtansine (T-DM1)
