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Trial record 5 of 172 for:    pertuzumab

Observational Study of Pertuzumab Safety in Participants With Breast Cancer

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ClinicalTrials.gov Identifier: NCT02266173
Recruitment Status : Recruiting
First Posted : October 16, 2014
Last Update Posted : October 8, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This Phase IV, prospective, multicenter, non-interventional study (regulatory post-marketing surveillance) will evaluate the safety of pertuzumab in approximately 3000 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.

Condition or disease Intervention/treatment
Breast Cancer Drug: Pertuzumab

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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-Marketing Surveillance of Perjeta in Breast Cancer
Actual Study Start Date : February 5, 2015
Estimated Primary Completion Date : May 28, 2021
Estimated Study Completion Date : May 28, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Pertuzumab

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 Name: Perjeta




Primary Outcome Measures :
  1. Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to approximately 6 years ]

Secondary Outcome Measures :
  1. 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) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02266173


Contacts
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Contact: Reference Study ID Number: ML29299 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

Locations
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Korea, Republic of
Inje university Haeundae Paik Hospital Terminated
Busan, Korea, Republic of, 48108
Pusan National University Hospital Active, not recruiting
Busan, Korea, Republic of, 49241
Kosin University Gospel Hospital Active, not recruiting
Busan, Korea, Republic of, 49267
Kyungpook National University Chilgok Hospital Active, not recruiting
Daegu, Korea, Republic of, 41404
Keimyung University Dongsan Medical Center Recruiting
Daegu, Korea, Republic of, 41931
Chungnam National University Hospital Active, not recruiting
Daejeon, Korea, Republic of, 35015
National Health Insurance Service Ilsan Hospital Recruiting
Gyeonggi-do, Korea, Republic of, 10444
Seoul National University Bundang Hospital Active, not recruiting
Gyeonggi-do, Korea, Republic of, 13620
Hallym University Sacred Heart Hospital Recruiting
Gyeonggi-do, Korea, Republic of, 14068
Soonchunhyang University Bucheon Hospital Recruiting
Gyeonggi-do, Korea, Republic of, 14584
St. Vincent's Hospital Active, not recruiting
Gyeonggi-do, Korea, Republic of, 16247
Ajou University Medical Center Active, not recruiting
Gyeonggi-do, Korea, Republic of, 16499
The Catholic University of Korea Bucheon St. Mary's Hospital Recruiting
Gyeonggi-do, Korea, Republic of
Pusan National University Yangsan Hospital Recruiting
Gyeongsangnam-do, Korea, Republic of, 50612
Catholic Univ. of Incheon St.Mary's Hospital Active, not recruiting
Incheon, Korea, Republic of, 21431
Inha University Hospital Active, not recruiting
Incheon, Korea, Republic of, 22332
Gil Hospital. Gachon University Active, not recruiting
Incheon, Korea, Republic of, 405-760
Catholic Kwandong University International St. Mary'S Hospital. Active, not recruiting
Incheon, Korea, Republic of
Chonnam National University Hwasun Hospital Active, not recruiting
Jeollanam-do, Korea, Republic of, 58128
Wonkwang University School of Medicine & Hospital Recruiting
Jeonlabuk-do, Korea, Republic of, 54538
Inje University, Sanggye-Paik Hospital Recruiting
Seoul, Korea, Republic of, 01757
Korea Cancer Hospital of Korea Institute of Radiological and Medical Sciences Active, not recruiting
Seoul, Korea, Republic of, 01812
Korea University Anam Hospital Active, not recruiting
Seoul, Korea, Republic of, 02841
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Kangbuk Samsung Hospital Terminated
Seoul, Korea, Republic of, 03181
Severance Hospital, Yonsei University Health System Active, not recruiting
Seoul, Korea, Republic of, 03722
Konkuk University Medical Center Recruiting
Seoul, Korea, Republic of, 05030
Gangdong Kyung Hee University Hospital Active, not recruiting
Seoul, Korea, Republic of, 05278
Asan Medical Center - Oncology Active, not recruiting
Seoul, Korea, Republic of, 05505
Gangnam Severance Hospital Recruiting
Seoul, Korea, Republic of, 06273
Seoul St Mary's Hospital Recruiting
Seoul, Korea, Republic of, 06591
ChungAng University Hospital Recruiting
Seoul, Korea, Republic of, 06973
Yeouido St. Mary's Hospital Active, not recruiting
Seoul, Korea, Republic of, 07345
Ewha Womans University Mokdong Hospital Active, not recruiting
Seoul, Korea, Republic of, 07985
Korea University Guro Hospital Active, not recruiting
Seoul, Korea, Republic of, 08308
SMG-SNU Boramae Medical Center Recruiting
Seoul, Korea, Republic of, 156-707
Samsung Medical Center Active, not recruiting
Seoul, Korea, Republic of, 6351
Ulsan University Hosiptal Recruiting
Ulsan, Korea, Republic of, 44033
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02266173     History of Changes
Other Study ID Numbers: ML29299
First Posted: October 16, 2014    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Pertuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents