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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pertuzumab | Participants for whom the treating physician has decided to administer pertuzumab according to standard of care and in line with the current summary of product characteristics (SmPC)/local labeling, will be observed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pertuzumab | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to approximately 6 years |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Overall Response as Determined Using Response Evaluation Criteria in Solid Tumors (RECIST) | Baseline until disease progression or death, whichever occurs earlier (assessed up to approximately 6 years) |
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Inclusion Criteria:
Exclusion Criteria:
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Adult participants with metastatic or locally unresectable recurrent breast cancer and have never received chemotherapy or anti-HER2 therapy for metastatic disease with HER2 positivity.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inje university Haeundae Paik Hospital | Busan | 48108 | South Korea | |||
| Pusan National University Hospital |
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|
| Busan |
| 49241 |
| South Korea |
| Kosin University Gospel Hospital | Busan | 49267 | South Korea |
| Kyungpook National University Chilgok Hospital | Daegu | 41404 | South Korea |
| Keimyung University Dongsan Medical Center | Daegu | 41931 | South Korea |
| Chungnam National University Hospital | Daejeon | 35015 | South Korea |
| National Health Insurance Service Ilsan Hospital | Gyeonggi-do | 10408 | South Korea |
| Hallym University Sacred Heart Hospital | Gyeonggi-do | 14068 | South Korea |
| Soonchunhyang University Bucheon Hospital | Gyeonggi-do | 14584 | South Korea |
| St. Vincent's Hospital | Gyeonggi-do | 16247 | South Korea |
| Ajou University Medical Center | Gyeonggi-do | 16499 | South Korea |
| The Catholic University of Korea Bucheon St. Mary's Hospital | Gyeonggi-do | South Korea |
| Pusan National University Yangsan Hospital | Gyeongsangnam-do | 50612 | South Korea |
| Catholic Univ. of Incheon St.Mary's Hospital | Incheon | 21431 | South Korea |
| Inha University Hospital | Incheon | 22332 | South Korea |
| Gil Hospital. Gachon University | Incheon | 405-760 | South Korea |
| Catholic Kwandong University International St. Mary'S Hospital. | Incheon | South Korea |
| Chonnam National University Hwasun Hospital | Jeollanam-do | 58128 | South Korea |
| Wonkwang University School of Medicine & Hospital | Jeonlabuk-do | 54538 | South Korea |
| Seoul National University Bundang Hospital | Seongnam-si | 13605 | South Korea |
| Samsung Medical Center | Seoul | (0)6351 | South Korea |
| Inje University, Sanggye-Paik Hospital | Seoul | 01757 | South Korea |
| Korea Cancer Center Hospital of Korea Institute of Radiological and Medical Sciences | Seoul | 01812 | South Korea |
| Korea University Anam Hospital | Seoul | 02841 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | 03722 | South Korea |
| Konkuk University Medical Center | Seoul | 05030 | South Korea |
| Gangdong Kyung Hee University Hospital | Seoul | 05278 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Gangnam Severance Hospital | Seoul | 06273 | South Korea |
| Seoul St Mary's Hospital | Seoul | 06591 | South Korea |
| ChungAng University Hospital | Seoul | 06973 | South Korea |
| Yeouido St. Mary's Hospital | Seoul | 07345 | South Korea |
| Ewha Womans University Mokdong Hospital | Seoul | 07985 | South Korea |
| Korea University Guro Hospital | Seoul | 08308 | South Korea |
| SMG-SNU Boramae Medical Center | Seoul | 156-707 | South Korea |
| Ulsan University Hosiptal | Ulsan | 44033 | South Korea |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C485206 | pertuzumab |
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