Observational Study of Pertuzumab Safety in Participants With Breast Cancer
- Registration Number
- NCT02266173
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1130
- 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
- Hypersensitivity for pertuzumab (Perjeta) or any of its excipients
- Contraindications to Perjeta according to SmPC
- Pregnancy and lactation
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Pertuzumab 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.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Baseline up to approximately 6 years
- Secondary Outcome Measures
Name Time Method 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)
Trial Locations
- Locations (37)
Inje university Haeundae Paik Hospital
🇰🇷Busan, Korea, Republic of
Pusan National University Hospital
🇰🇷Busan, Korea, Republic of
Kyungpook National University Chilgok Hospital
🇰🇷Daegu, Korea, Republic of
The Catholic University of Korea Bucheon St. Mary's Hospital
🇰🇷Gyeonggi-do, Korea, Republic of
National Health Insurance Service Ilsan Hospital
🇰🇷Gyeonggi-do, Korea, Republic of
Soonchunhyang University Bucheon Hospital
🇰🇷Gyeonggi-do, Korea, Republic of
Chonnam National University Hwasun Hospital
🇰🇷Jeollanam-do, Korea, Republic of
Catholic Univ. of Incheon St.Mary's Hospital
🇰🇷Incheon, Korea, Republic of
Pusan National University Yangsan Hospital
🇰🇷Gyeongsangnam-do, Korea, Republic of
Catholic Kwandong University International St. Mary'S Hospital.
🇰🇷Incheon, Korea, Republic of
Wonkwang University School of Medicine & Hospital
🇰🇷Jeonlabuk-do, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Korea, Republic of
Inje University, Sanggye-Paik Hospital
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Konkuk University Medical Center
🇰🇷Seoul, Korea, Republic of
Gangdong Kyung Hee University Hospital
🇰🇷Seoul, Korea, Republic of
Seoul St Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
SMG-SNU Boramae Medical Center
🇰🇷Seoul, Korea, Republic of
Kosin University Gospel Hospital
🇰🇷Busan, Korea, Republic of
Keimyung University Dongsan Medical Center
🇰🇷Daegu, Korea, Republic of
Hallym University Sacred Heart Hospital
🇰🇷Gyeonggi-do, Korea, Republic of
St. Vincent's Hospital
🇰🇷Gyeonggi-do, Korea, Republic of
Ajou University Medical Center
🇰🇷Gyeonggi-do, Korea, Republic of
Gil Hospital. Gachon University
🇰🇷Incheon, Korea, Republic of
Inha University Hospital
🇰🇷Incheon, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Korea Cancer Center Hospital of Korea Institute of Radiological and Medical Sciences
🇰🇷Seoul, Korea, Republic of
Gangnam Severance Hospital
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Yeouido St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
ChungAng University Hospital
🇰🇷Seoul, Korea, Republic of
Ewha Womans University Mokdong Hospital
🇰🇷Seoul, Korea, Republic of
Chungnam National University Hospital
🇰🇷Daejeon, Korea, Republic of
Ulsan University Hosiptal
🇰🇷Ulsan, Korea, Republic of