This Phase IV, prospective, multicenter, non-interventional study (regulatory post-marketing surveillance) will evaluate the safety of pertuzumab in approximately 1000 participants with metastatic or locally unresectable recurrent breast cancer who have never received chemotherapy or anti-human epidermal growth factor receptor 2 (HER2) therapy for their metastatic disease with HER2 positivity in Korea. Participants who are administered with pertuzumab according to medical opinions of the doctor in charge of surveillance will be registered for this study and treated with pertuzumab under the approval conditions of the product in Korea.
Study Type
OBSERVATIONAL
Enrollment
1,130
Study protocol does not specify/enforce any particular dosage regimen. Pertuzumab will be administered according to standard of care and in line with current SmPC/local labelling.
Inje university Haeundae Paik Hospital
Busan, South Korea
Pusan National University Hospital
Busan, South Korea
Kosin University Gospel Hospital
Busan, South Korea
Kyungpook National University Chilgok Hospital
Daegu, South Korea
Keimyung University Dongsan Medical Center
Daegu, South Korea
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Baseline up to approximately 6 years
Percentage of Participants With Overall Response as Determined Using Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: Baseline until disease progression or death, whichever occurs earlier (assessed up to approximately 6 years)
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Chungnam National University Hospital
Daejeon, South Korea
National Health Insurance Service Ilsan Hospital
Gyeonggi-do, South Korea
Hallym University Sacred Heart Hospital
Gyeonggi-do, South Korea
Soonchunhyang University Bucheon Hospital
Gyeonggi-do, South Korea
St. Vincent's Hospital
Gyeonggi-do, South Korea
...and 27 more locations