Observational Study of Pertuzumab Safety in Participants With Breast Cancer

Breast Cancer Clinical Trial

Official title:

Post-Marketing Surveillance of Perjeta in Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02266173
• Other study ID #: ML29299
• Status: Completed
• Start date: February 5, 2015
• Est. completion date: March 8, 2021

Study information

• Verified date: April 2021
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1130
• Est. completion date: March 8, 2021
• Est. primary completion date: March 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Inje university Haeundae Paik Hospital	Busan
Korea, Republic of	Kosin University Gospel Hospital	Busan
Korea, Republic of	Pusan National University Hospital	Busan
Korea, Republic of	Keimyung University Dongsan Medical Center	Daegu
Korea, Republic of	Kyungpook National University Chilgok Hospital	Daegu
Korea, Republic of	Chungnam National University Hospital	Daejeon
Korea, Republic of	Ajou University Medical Center	Gyeonggi-do
Korea, Republic of	Hallym University Sacred Heart 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	St. Vincent's Hospital	Gyeonggi-do
Korea, Republic of	The Catholic University of Korea Bucheon St. Mary's Hospital	Gyeonggi-do
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	Catholic Univ. of Incheon St.Mary's Hospital	Incheon
Korea, Republic of	Gil Hospital. Gachon University	Incheon
Korea, Republic of	Inha University Hospital	Incheon
Korea, Republic of	Chonnam National University Hwasun Hospital	Jeollanam-do
Korea, Republic of	Wonkwang University School of Medicine & Hospital	Jeonlabuk-do
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	ChungAng University Hospital	Seoul
Korea, Republic of	Ewha Womans University Mokdong Hospital	Seoul
Korea, Republic of	Gangdong Kyung Hee University Hospital	Seoul
Korea, Republic of	Gangnam Severance Hospital	Seoul
Korea, Republic of	Inje University, Sanggye-Paik Hospital	Seoul
Korea, Republic of	Konkuk University Medical Center	Seoul
Korea, Republic of	Korea Cancer Center Hospital of Korea Institute of Radiological and Medical Sciences	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Seoul St Mary's Hospital	Seoul
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul
Korea, Republic of	SMG-SNU Boramae Medical Center	Seoul
Korea, Republic of	Yeouido St. Mary's Hospital	Seoul
Korea, Republic of	Ulsan University Hosiptal	Ulsan

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)		Baseline up to approximately 6 years
Secondary	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)