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 : September 21, 2020
|Condition or disease||Intervention/treatment|
|Breast Cancer||Drug: Pertuzumab|
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|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|
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.
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
- Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to approximately 6 years ]
- 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) ]
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
|Contact: Reference Study ID Number: ML29299 www.roche.com/about_roche/roche_worldwide.htm||888-662-6728 (U.S. and Canada)||firstname.lastname@example.org|
|Study Director:||Clinical Trials||Hoffmann-La Roche|