HER2 positive unresectable and/or metastatic breast cancer subjects who are resistant or refractory to T-DM1
Conditions
Sponsors
DAIICHI SANKYO Co.,Ltd.
AstraZeneca
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Men or women the age of majority in their country 2.Has pathologically documented breast cancer that: is unresectable or metastatic has HER2 positive expression confirmed per protocol 3.Has an adequate tumor sample 4.Has at least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 5.Has protocol-defined adequate cardiac, renal and hepatic function 6.Agrees to follow protocol-defined method(s) of contraception
Exclusion criteria
Exclusion criteria: 1.Has a medical history of myocardial infarction, symptomatic CHF (NYHA classes II-IV), unstable angina or serious cardiac arrhythmia 2.Has a QTc prolongation to > 450 millisecond (ms) in males and > 470 ms in females 3.Has a medical history of clinically significant lung disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Objective response rate (ORR) assessment by independent central imaging facility review based on RECIST version 1.1. | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy pharmacokinetics Duration of response, best percent change in the sum of the longest diameters of measurable tumors, disease control rate, clinical benefit rate, progression free survival, overall survival, ORR assessed by the investigator based on RECIST version 1.1, Pharmacokinetics, safety | — |
Countries
Asia except Japan, Europe, Japan, North America
Contacts
Public ContactContact for Clinical Trial Information
DAIICHI SANKYO Co.,Ltd.
Outcome results
None listed