Status:
COMPLETED
An Observational Study of Kadcyla Safety in Breast Cancer
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Brief 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). Patien...
Eligibility Criteria
Inclusion
- Patients who are administered with Kadcyla at physician's discretion will be registered for this study. The use of Kadcyla in the patients must fall into the approved indication in Korea.
Exclusion
- Patients not receiving treatment for breast cancer with Kadcyla according to standard of care and in line with the current summary of product characteristics (SPC)/local labeling.
- A pediatric patient (age ≤18 years)
- Hypersensitivity for Kadcyla or any ingredient in this product
Key Trial Info
Start Date :
May 21 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 10 2021
Estimated Enrollment :
563 Patients enrolled
Trial Details
Trial ID
NCT02305641
Start Date
May 21 2015
End Date
August 10 2021
Last Update
January 11 2023
Active Locations (38)
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1
Inje University Busan Paik Hospital
Busan, South Korea, 47392
2
Dong-A University Hospital
Busan, South Korea, 49201
3
Kosin University Gospel Hospital
Busan, South Korea, 49267
4
Pusan National University Hospital
Busan, South Korea, 602-739