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Observational Study of Pertuzumab Safety in Participants With Breast Cancer

NCT ID: NCT02266173

Last Updated: 2021-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1130 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-02-05

Study Completion Date

2021-03-08

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Pertuzumab

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Perjeta

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Inje university Haeundae Paik Hospital

Busan, , South Korea

Site Status

Pusan National University Hospital

Busan, , South Korea

Site Status

Kosin University Gospel Hospital

Busan, , South Korea

Site Status

Kyungpook National University Chilgok Hospital

Daegu, , South Korea

Site Status

Keimyung University Dongsan Medical Center

Daegu, , South Korea

Site Status

Chungnam National University Hospital

Daejeon, , South Korea

Site Status

National Health Insurance Service Ilsan Hospital

Gyeonggi-do, , South Korea

Site Status

Hallym University Sacred Heart Hospital

Gyeonggi-do, , South Korea

Site Status

Soonchunhyang University Bucheon Hospital

Gyeonggi-do, , South Korea

Site Status

St. Vincent's Hospital

Gyeonggi-do, , South Korea

Site Status

Ajou University Medical Center

Gyeonggi-do, , South Korea

Site Status

The Catholic University of Korea Bucheon St. Mary's Hospital

Gyeonggi-do, , South Korea

Site Status

Pusan National University Yangsan Hospital

Gyeongsangnam-do, , South Korea

Site Status

Catholic Univ. of Incheon St.Mary's Hospital

Incheon, , South Korea

Site Status

Inha University Hospital

Incheon, , South Korea

Site Status

Gil Hospital. Gachon University

Incheon, , South Korea

Site Status

Catholic Kwandong University International St. Mary'S Hospital.

Incheon, , South Korea

Site Status

Chonnam National University Hwasun Hospital

Jeollanam-do, , South Korea

Site Status

Wonkwang University School of Medicine & Hospital

Jeonlabuk-do, , South Korea

Site Status

Seoul National University Bundang Hospital

Seongnam-si, , South Korea

Site Status

Samsung Medical Center

Seoul, , South Korea

Site Status

Inje University, Sanggye-Paik Hospital

Seoul, , South Korea

Site Status

Korea Cancer Center Hospital of Korea Institute of Radiological and Medical Sciences

Seoul, , South Korea

Site Status

Korea University Anam Hospital

Seoul, , South Korea

Site Status

Seoul National University Hospital

Seoul, , South Korea

Site Status

Severance Hospital, Yonsei University Health System

Seoul, , South Korea

Site Status

Konkuk University Medical Center

Seoul, , South Korea

Site Status

Gangdong Kyung Hee University Hospital

Seoul, , South Korea

Site Status

Asan Medical Center

Seoul, , South Korea

Site Status

Gangnam Severance Hospital

Seoul, , South Korea

Site Status

Seoul St Mary's Hospital

Seoul, , South Korea

Site Status

ChungAng University Hospital

Seoul, , South Korea

Site Status

Yeouido St. Mary's Hospital

Seoul, , South Korea

Site Status

Ewha Womans University Mokdong Hospital

Seoul, , South Korea

Site Status

Korea University Guro Hospital

Seoul, , South Korea

Site Status

SMG-SNU Boramae Medical Center

Seoul, , South Korea

Site Status

Ulsan University Hosiptal

Ulsan, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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ML29299

Identifier Type: -

Identifier Source: org_study_id

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