Observational Study of Pertuzumab Safety in Participants With Breast Cancer

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Pertuzumab

• Registration Number: NCT02266173
• Lead Sponsor: 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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-09-30
• Study First Submitted QC: 2014-10-13
• Study First Posted: 2014-10-16
• Study Start: 2015-02-05
• Primary Completion: 2021-03-08
• Study Completion: 2021-03-08
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-30
• Last Update Posted: 2021-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1130

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pertuzumab	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	Baseline up to approximately 6 years

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (37)

Inje university Haeundae Paik Hospital; 🇰🇷 Busan, Korea, Republic of

Pusan National University Hospital; 🇰🇷 Busan, Korea, Republic of

Kosin University Gospel Hospital; 🇰🇷 Busan, Korea, Republic of

Kyungpook National University Chilgok Hospital; 🇰🇷 Daegu, Korea, Republic of

Keimyung University Dongsan Medical Center; 🇰🇷 Daegu, Korea, Republic of

Chungnam National University Hospital; 🇰🇷 Daejeon, Korea, Republic of

National Health Insurance Service Ilsan Hospital; 🇰🇷 Gyeonggi-do, Korea, Republic of

Hallym University Sacred Heart Hospital; 🇰🇷 Gyeonggi-do, Korea, Republic of

Soonchunhyang University Bucheon Hospital; 🇰🇷 Gyeonggi-do, Korea, Republic of

St. Vincent's Hospital; 🇰🇷 Gyeonggi-do, Korea, Republic of

Scroll for more (27 remaining)