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Outcomes Of The Spanish Cohort Of Early Access To Pertuzumab And Trastuzumab Emtansine — KNOWHER  

Breast Neoplasms Clinical Trial

Official title:
Use Of Pertuzumab And Trastuzumab Emtansine In Adult Patients With Her2-Positive Metastatic Or Locally Recurrent Unresectable Breast Cancer

Clinical Trial Summary

The overall study objective is to evaluate the effectiveness and safety of Trastuzumab emtansine (T-DM1) and Pertuzumab under real-world disease conditions in the Spain, and specifically in patients treated under compassionate use or early access program

Clinical Trial Description

This is a retrospective, non-interventional, non-comparative, observational cohort study / registry in the Spain. The study design will reflect real-life clinical management of patients with HER2-positive MBC. Type and frequency of actual patient visits and all evaluations will be done as for routine clinical practice.

The analysis of the efficacy and safety results obtained in patients receiving pertuzumab or TDM1 in those early access systems is of utmost importance. These real-world patients with advanced breast cancer may have different characteristics than those enrolled in clinical trials and clinicians must often extrapolate into therapeutic decisions not fully supported by a robust evidence. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03025711
Study type Observational
Source Puerta de Hierro University Hospital
Contact
Status Completed
Phase
Start date December 1, 2017
Completion date January 31, 2020
View Details
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