Clinical trial NCT02266173: Observational Study of Pertuzumab Safety in Participants With Breast Cancer
Official title: Post-Marketing Surveillance of Perjeta in Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2014-10-16
Enrollment: 1130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility 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

Primary outcomes:
measure: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to approximately 6 years
Secondary outcomes:
measure: Percentage of Participants With Overall Response as Determined Using Response Evaluation Criteria in Solid Tumors (RECIST)
timeFrame: Baseline until disease progression or death, whichever occurs earlier (assessed up to approximately 6 years)
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Inje university Haeundae Paik Hospital
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Busan
country: Korea, Republic of
facility: Kosin University Gospel Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: National Health Insurance Service Ilsan Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Soonchunhyang University Bucheon Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: St. Vincent's Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Ajou University Medical Center
city: Gyeonggi-do
country: Korea, Republic of
facility: The Catholic University of Korea Bucheon St. Mary's Hospital
city: Gyeongsangnam-do
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
city: Incheon
country: Korea, Republic of
facility: Catholic Univ. of Incheon St.Mary's Hospital
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Incheon
country: Korea, Republic of
facility: Gil Hospital. Gachon University
city: Incheon
country: Korea, Republic of
facility: Catholic Kwandong University International St. Mary'S Hospital.
city: Jeollanam-do
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
city: Jeonlabuk-do
country: Korea, Republic of
facility: Wonkwang University School of Medicine & Hospital
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Inje University, Sanggye-Paik Hospital
city: Seoul
country: Korea, Republic of
facility: Korea Cancer Center Hospital of Korea Institute of Radiological and Medical Sciences
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
city: Seoul
country: Korea, Republic of
facility: Gangdong Kyung Hee University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul St Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: ChungAng University Hospital
city: Seoul
country: Korea, Republic of
facility: Yeouido St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: SMG-SNU Boramae Medical Center
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hosiptal
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: