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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort | Method of continuous surveillance per standard of care |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety (composite outcome measure): Incidence of serious adverse events (SAEs), adverse drug reactions (ADRs); unexpected adverse events and ADRs; expected ADRs; non-serious ADRs | Up to 8 years |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy (composite outcome measure): Tumor response to Kadcyla treatment including complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD) | Up to 8 years |
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Inclusion Criteria:
Exclusion Criteria:
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Korean patients administered Kadcyla infusion at physician's discretion
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inje University Busan Paik Hospital | Busan | 47392 | South Korea | |||
| Dong-A University Hospital |
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| Busan |
| 49201 |
| South Korea |
| Kosin University Gospel Hospital | Busan | 49267 | South Korea |
| Pusan National University Hospital | Busan | 602-739 | South Korea |
| Kyungpook National University Chilgok Hospital | Daegu | 41404 | South Korea |
| Keimyung University Dongsan Medical Center | Daegu | 41931 | South Korea |
| Yeungnam University Medical Center; Surgical Department of Breast and Internal Secretion | Daegu | South Korea |
| Chungnam National University Hospital | Daejeon | 35015 | South Korea |
| Uijeongbu St. Mary's Hospital | Gyeonggi-do | 11765 | South Korea |
| Hallym University Sacred Heart Hospital | Gyeonggi-do | 14068 | South Korea |
| Soonchunhyang University Bucheon Hospital | Gyeonggi-do | 14584 | South Korea |
| Bucheon St Mary's hospital | Gyeonggi-do | 14647 | South Korea |
| St. Vincent's Hospital | Gyeonggi-do | 16247 | South Korea |
| Pusan National University Yangsan Hospital | Gyeongsangnam-do | 50612 | South Korea |
| Gachon University Gil Medical Center | Incheon | 21565 | South Korea |
| Inha University Hospital | Incheon | 22332 | South Korea |
| Catholic Kwandong University International St. Mary'S Hospital. | Incheon | South Korea |
| Chonbuk National Uni Hospital | Jeollabuk-do | 561-712 | South Korea |
| Chonnam National University Hwasun Hospital | Jeollanam-do | 58128 | South Korea |
| Presbyterian Medical Center | Jeonju | 54987 | South Korea |
| Wonkwang University School of Medicine & Hospital | Jeonlabuk-do | 54538 | South Korea |
| NHIC Ilsan Hospital | Kyonggi-do | 411-719 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | 003-722 | 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 |
| Kangbuk Samsung Hospital | Seoul | 03181 | 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 |
| 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 |
| Samsung Medical Center | Seoul | 135-710 | South Korea |
| SMG-SNU Boramae Medical Center | Seoul | 156-707 | South Korea |
| Ajou University Hospital | Suwon | 443-721 | 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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