Status:
TERMINATED
A Study of DS-8201a in Metastatic Breast Cancer Previously Treated With Trastuzumab Emtansine (T-DM1)
Lead Sponsor:
Daiichi Sankyo
Collaborating Sponsors:
AstraZeneca
Daiichi Sankyo Co., Ltd.
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Some human epidermal growth factor receptor 2 (HER-2) breast cancer patients do not respond or become resistant to current treatment. DS-8201a is a new experimental product that is a combination of an...
Eligibility Criteria
Inclusion
- Men or women the age of majority in their country
- Has pathologically documented breast cancer that:
- is unresectable or metastatic
- 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
Exclusion
- 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:
- safety or well-being of the participant or offspring
- safety of study staff
- analysis of results
Key Trial Info
Start Date :
August 25 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 6 2024
Estimated Enrollment :
253 Patients enrolled
Trial Details
Trial ID
NCT03248492
Start Date
August 25 2017
End Date
May 6 2024
Last Update
June 26 2025
Active Locations (99)
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1
Alaska Urological Institute dba Alaska Clinical Research Center
Anchorage, Alaska, United States, 99508
2
Arizona Oncology Associates
Tucson, Arizona, United States, 85704
3
The Regents of the University of California
Los Angeles, California, United States, 90095
4
Sharp Clinical Oncology Research
San Diego, California, United States, 92123