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This is a phase IV, prospective, multicenter, observational study (regulatory post-marketing surveillance) in approximately 600 patients who are to receive Herceptin SC (trastuzumab, subcutaneous administration) per approved local labeling. Patients will be under observation according to standard of care in Korea.
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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 adverse events (AEs), serious adverse events (SAEs), adverse events of special interest, pregnancies, adverse drug reactions (ADRs); unexpected ADRs; expected ADRs | Up to 6 years |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: Pathological Complete Response (pCR) in neoadjuvant early breast cancer (EBC) | Up to 6 years | |
| Efficacy: Overall response per Response Evaluation Criteria in Solid Tumors (RECIST) | Up to 6 years |
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Inclusion Criteria:
- All patients administered Herceptin SC for the locally approved indications
Exclusion Criteria:
N/A
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Patients receiving treatment for breast cancer with Herceptin SC under observation according to standard of care and in line with the current local labeling in Korea.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pusan National University Hospital | Busan | 49241 | South Korea | |||
| Kosin University Gospel Hospital |
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| Busan |
| 49267 |
| South Korea |
| Keimyung University Dongsan Medical Center | Daegu | 41931 | South Korea |
| Myongji Hospital | Gyeonggi-do | 10475 | South Korea |
| Hallym University Sacred Heart Hospital | Gyeonggi-do | 14068 | South Korea |
| Ajou University Medical Center | Gyeonggi-do | 16499 | South Korea |
| Pusan National University Yangsan Hospital | Gyeongsangnam-do | 50612 | South Korea |
| Gyeongsang National University Hospital | Gyeongsangnam-do | 52727 | South Korea |
| Gachon University Gil Medical Center | Incheon | 21565 | South Korea |
| Inha University Hospital | Incheon | 22332 | South Korea |
| Chonnam National University Hwasun Hospital | Jeollanam-do | 58128 | South Korea |
| Wonkwang University School of Medicine & Hospital | Jeonlabuk-do | 54538 | South Korea |
| Samsung Medical Center | Seoul | (0)6351 | South Korea |
| Inje University, Sanggye-Paik Hospital | Seoul | 01757 | South Korea |
| Korea Cancer Hospital of Korea Institute of Radiological and Medical Sciences | Seoul | 01812 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | 03722 | South Korea |
| Cheil General Hospital & Women's Healthcare Center | Seoul | 04619 | South Korea |
| Gangnam Severance Hospital | Seoul | 06273 | South Korea |
| ChungAng University Hospital | Seoul | 06973 | South Korea |
| Borame Medical Center | Seoul | 07061 | South Korea |
| Ewha Womans University Mokdong Hospital | Seoul | 07985 | South Korea |
| Miz Medi Hospital | Seoul | 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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