Status:
COMPLETED
Observational Study of Pertuzumab Safety in Participants With Breast Cancer
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
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 ...
Eligibility Criteria
Inclusion
- 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
- Hypersensitivity for pertuzumab (Perjeta) or any of its excipients
- Contraindications to Perjeta according to SmPC
- Pregnancy and lactation
Key Trial Info
Start Date :
February 5 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 8 2021
Estimated Enrollment :
1130 Patients enrolled
Trial Details
Trial ID
NCT02266173
Start Date
February 5 2015
End Date
March 8 2021
Last Update
May 3 2021
Active Locations (37)
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1
Inje university Haeundae Paik Hospital
Busan, South Korea, 48108
2
Pusan National University Hospital
Busan, South Korea, 49241
3
Kosin University Gospel Hospital
Busan, South Korea, 49267
4
Kyungpook National University Chilgok Hospital
Daegu, South Korea, 41404