Observational Study of Pertuzumab Safety in Participants With Breast Cancer
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Drug: Pertuzumab
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.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Baseline up to approximately 6 years]
Secondary Outcome Measures
- 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)]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Participants with metastatic or locally unresectable recurrent breast cancer who have never received chemotherapy or anti-HER2 therapy for metastatic disease with HER2 positivity
-
HER2-positive, locally advanced, inflammatory, or early stage breast cancer (greater than [>]2 centimeters [cm] in diameter) participants who have never received chemotherapy and surgery for breast cancer
Exclusion Criteria:
-
Hypersensitivity for pertuzumab (Perjeta) or any of its excipients
-
Contraindications to Perjeta according to SmPC
-
Pregnancy and lactation
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Inje university Haeundae Paik Hospital | Busan | Korea, Republic of | 48108 | |
| 2 | Pusan National University Hospital | Busan | Korea, Republic of | 49241 | |
| 3 | Kosin University Gospel Hospital | Busan | Korea, Republic of | 49267 | |
| 4 | Kyungpook National University Chilgok Hospital | Daegu | Korea, Republic of | 41404 | |
| 5 | Keimyung University Dongsan Medical Center | Daegu | Korea, Republic of | 41931 | |
| 6 | Chungnam National University Hospital | Daejeon | Korea, Republic of | 35015 | |
| 7 | National Health Insurance Service Ilsan Hospital | Gyeonggi-do | Korea, Republic of | 10408 | |
| 8 | Hallym University Sacred Heart Hospital | Gyeonggi-do | Korea, Republic of | 14068 | |
| 9 | Soonchunhyang University Bucheon Hospital | Gyeonggi-do | Korea, Republic of | 14584 | |
| 10 | St. Vincent's Hospital | Gyeonggi-do | Korea, Republic of | 16247 | |
| 11 | Ajou University Medical Center | Gyeonggi-do | Korea, Republic of | 16499 | |
| 12 | The Catholic University of Korea Bucheon St. Mary's Hospital | Gyeonggi-do | Korea, Republic of | ||
| 13 | Pusan National University Yangsan Hospital | Gyeongsangnam-do | Korea, Republic of | 50612 | |
| 14 | Catholic Univ. of Incheon St.Mary's Hospital | Incheon | Korea, Republic of | 21431 | |
| 15 | Inha University Hospital | Incheon | Korea, Republic of | 22332 | |
| 16 | Gil Hospital. Gachon University | Incheon | Korea, Republic of | 405-760 | |
| 17 | Catholic Kwandong University International St. Mary'S Hospital. | Incheon | Korea, Republic of | ||
| 18 | Chonnam National University Hwasun Hospital | Jeollanam-do | Korea, Republic of | 58128 | |
| 19 | Wonkwang University School of Medicine & Hospital | Jeonlabuk-do | Korea, Republic of | 54538 | |
| 20 | Seoul National University Bundang Hospital | Seongnam-si | Korea, Republic of | 13605 | |
| 21 | Samsung Medical Center | Seoul | Korea, Republic of | (0)6351 | |
| 22 | Inje University, Sanggye-Paik Hospital | Seoul | Korea, Republic of | 01757 | |
| 23 | Korea Cancer Center Hospital of Korea Institute of Radiological and Medical Sciences | Seoul | Korea, Republic of | 01812 | |
| 24 | Korea University Anam Hospital | Seoul | Korea, Republic of | 02841 | |
| 25 | Seoul National University Hospital | Seoul | Korea, Republic of | 03080 | |
| 26 | Severance Hospital, Yonsei University Health System | Seoul | Korea, Republic of | 03722 | |
| 27 | Konkuk University Medical Center | Seoul | Korea, Republic of | 05030 | |
| 28 | Gangdong Kyung Hee University Hospital | Seoul | Korea, Republic of | 05278 | |
| 29 | Asan Medical Center | Seoul | Korea, Republic of | 05505 | |
| 30 | Gangnam Severance Hospital | Seoul | Korea, Republic of | 06273 | |
| 31 | Seoul St Mary's Hospital | Seoul | Korea, Republic of | 06591 | |
| 32 | ChungAng University Hospital | Seoul | Korea, Republic of | 06973 | |
| 33 | Yeouido St. Mary's Hospital | Seoul | Korea, Republic of | 07345 | |
| 34 | Ewha Womans University Mokdong Hospital | Seoul | Korea, Republic of | 07985 | |
| 35 | Korea University Guro Hospital | Seoul | Korea, Republic of | 08308 | |
| 36 | SMG-SNU Boramae Medical Center | Seoul | Korea, Republic of | 156-707 | |
| 37 | Ulsan University Hosiptal | Ulsan | Korea, Republic of | 44033 |
Sponsors and Collaborators
- Hoffmann-La Roche
Investigators
- Study Director: Clinical Trials, Hoffmann-La Roche
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ML29299