Observational Study of Pertuzumab Safety in Participants With Breast Cancer

April 30, 2021 updated by: Hoffmann-La Roche

Post-Marketing Surveillance of Perjeta in Breast Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1130

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of, 49241
        • Pusan National University Hospital
      • Busan, Korea, Republic of, 48108
        • Inje University Haeundae Paik Hospital
      • Busan, Korea, Republic of, 49267
        • Kosin University Gospel Hospital
      • Daegu, Korea, Republic of, 41404
        • Kyungpook National University Chilgok Hospital
      • Daegu, Korea, Republic of, 41931
        • Keimyung University Dongsan Medical Center
      • Daejeon, Korea, Republic of, 35015
        • Chungnam National University Hospital
      • Gyeonggi-do, Korea, Republic of, 16247
        • St. Vincent's Hospital
      • Gyeonggi-do, Korea, Republic of, 16499
        • Ajou University Medical Center
      • Gyeonggi-do, Korea, Republic of, 14068
        • Hallym University Sacred Heart Hospital
      • Gyeonggi-do, Korea, Republic of, 14584
        • Soonchunhyang University Bucheon Hospital
      • Gyeonggi-do, Korea, Republic of, 10408
        • National Health Insurance Service Ilsan Hospital
      • Gyeonggi-do, Korea, Republic of
        • The Catholic University Of Korea Bucheon St. Mary's Hospital
      • Gyeongsangnam-do, Korea, Republic of, 50612
        • Pusan National University Yangsan Hospital
      • Incheon, Korea, Republic of, 22332
        • Inha University Hospital
      • Incheon, Korea, Republic of
        • Catholic Kwandong University International St. Mary'S Hospital.
      • Incheon, Korea, Republic of, 21431
        • Catholic Univ. of Incheon St.Mary's Hospital
      • Incheon, Korea, Republic of, 405-760
        • Gil Hospital. Gachon University
      • Jeollanam-do, Korea, Republic of, 58128
        • Chonnam National University Hwasun Hospital
      • Jeonlabuk-do, Korea, Republic of, 54538
        • Wonkwang University School of Medicine & Hospital
      • Seongnam-si, Korea, Republic of, 13605
        • Seoul National University Bundang Hospital
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 03722
        • Severance Hospital, Yonsei University Health System
      • Seoul, Korea, Republic of, 05030
        • Konkuk University Medical Center
      • Seoul, Korea, Republic of, 156-707
        • SMG-SNU Boramae Medical Center
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
      • Seoul, Korea, Republic of, 02841
        • Korea University Anam Hospital
      • Seoul, Korea, Republic of, 07985
        • Ewha Womans University Mokdong Hospital
      • Seoul, Korea, Republic of, 08308
        • Korea University Guro Hospital
      • Seoul, Korea, Republic of, 01812
        • Korea Cancer Center Hospital of Korea Institute of Radiological and Medical Sciences
      • Seoul, Korea, Republic of, 06273
        • Gangnam Severance Hospital
      • Seoul, Korea, Republic of, 06591
        • Seoul St Mary's Hospital
      • Seoul, Korea, Republic of, 06973
        • Chungang University Hospital
      • Seoul, Korea, Republic of, 05278
        • Gangdong Kyung Hee University Hospital
      • Seoul, Korea, Republic of, 07345
        • Yeouido St. Mary's Hospital
      • Seoul, Korea, Republic of, 01757
        • Inje University, Sanggye-Paik Hospital
      • Seoul, Korea, Republic of, (0)6351
        • Samsung Medical Center
      • Ulsan, Korea, Republic of, 44033
        • Ulsan University Hosiptal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.
Other Names:
  • Perjeta

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Baseline up to approximately 6 years
Baseline up to approximately 6 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants With Overall Response as Determined Using Response Evaluation Criteria in Solid Tumors (RECIST)
Time Frame: Baseline until disease progression or death, whichever occurs earlier (assessed up to approximately 6 years)
Baseline until disease progression or death, whichever occurs earlier (assessed up to approximately 6 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 5, 2015

Primary Completion (Actual)

March 8, 2021

Study Completion (Actual)

March 8, 2021

Study Registration Dates

First Submitted

September 30, 2014

First Submitted That Met QC Criteria

October 13, 2014

First Posted (Estimate)

October 16, 2014

Study Record Updates

Last Update Posted (Actual)

May 3, 2021

Last Update Submitted That Met QC Criteria

April 30, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML29299

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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