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.
Study Type
OBSERVATIONAL
Enrollment
563
Safety (composite outcome measure): Incidence of serious adverse events (SAEs), adverse drug reactions (ADRs); unexpected adverse events and ADRs; expected ADRs; non-serious ADRs
Time frame: Up to 8 years
Efficacy (composite outcome measure): Tumor response to Kadcyla treatment including complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD)
Time frame: Up to 8 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Inje University Busan Paik Hospital
Busan, South Korea
Dong-A University Hospital
Busan, South Korea
Kosin University Gospel Hospital
Busan, South Korea
Pusan National University Hospital
Busan, South Korea
Kyungpook National University Chilgok Hospital
Daegu, South Korea
Keimyung University Dongsan Medical Center
Daegu, South Korea
Yeungnam University Medical Center; Surgical Department of Breast and Internal Secretion
Daegu, South Korea
Chungnam National University Hospital
Daejeon, South Korea
Uijeongbu St. Mary's Hospital
Gyeonggi-do, South Korea
Hallym University Sacred Heart Hospital
Gyeonggi-do, South Korea
...and 28 more locations