An Observational Study of Kadcyla Safety in Breast Cancer
NCT02305641 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 563
Last updated 2023-01-11
Summary
This is a phase IV, prospective, multicenter, non-interventional study (regulatory post-marketing surveillance) in approximately 500 patients who are to receive Kadcyla (trastuzumab emtansine). Patients administered Kadcyla infusion at physician's discretion will be registered for this surveillance in Korea. Patients will be asked to provide informed consent; data will be collected by electronic Case Report Forms for approximately 8 years.
Conditions
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Clinical Trials · Hoffmann-La Roche
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-05-21
- Primary Completion
- 2021-08-10
- Completion
- 2021-08-10
Countries
- South Korea
Study Locations
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