Observational Study of Pertuzumab Safety in Participants With Breast Cancer
Post-Marketing Surveillance of Perjeta in Breast Cancer
1 other identifier
observational
1,130
1 country
37
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2015
Longer than P75 for all trials
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2014
CompletedFirst Posted
Study publicly available on registry
October 16, 2014
CompletedStudy Start
First participant enrolled
February 5, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 8, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 8, 2021
CompletedMay 3, 2021
April 1, 2021
6.1 years
September 30, 2014
April 30, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Baseline up to approximately 6 years
Secondary Outcomes (1)
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)
Study Arms (1)
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.
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- Hypersensitivity for pertuzumab (Perjeta) or any of its excipients
- Contraindications to Perjeta according to SmPC
- Pregnancy and lactation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (37)
Inje university Haeundae Paik Hospital
Busan, 48108, South Korea
Pusan National University Hospital
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2014
First Posted
October 16, 2014
Study Start
February 5, 2015
Primary Completion
March 8, 2021
Study Completion
March 8, 2021
Last Updated
May 3, 2021
Record last verified: 2021-04