Observational Study of Pertuzumab Safety in Participants With 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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Inje university Haeundae Paik Hospital, Busan, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pertuzumab

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.

Other names: Perjeta

Primary outcomes

Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame: Baseline up to approximately 6 years

Secondary outcomes

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)

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

Post-Marketing Surveillance of Perjeta in Breast Cancer

Important dates

Study start: 2015
Primary completion: 2021
Study completion: 2021
First posted: Oct 16, 2014
Registry last updated: May 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed