AryoTrust® (Trastuzumab) Safety Study

Status Completed

Clinical Trial Summary

This study was a phase IV, observational, multicenter, single-arm, open-label, post-marketing surveillance study for the assessment of AryoTrust safety in Iranian HER2-positive breast cancer patients undergoing adjuvant chemotherapy regimens.

Clinical Trial Description

The present study is an observational, multicenter, non-interventional, single-arm, open-label PMS study conducted in Iran. No control groups are included in the study design. The objective of this PMS study is to monitor and assess the safety of AryoTrust in patients with non-metastatic HER2-positive breast cancer in adjuvant setting over a period of 27 weeks. Treatment with AryoTrust in this study is defined as the administration of 6mg/kg AryoTrust, every 3 weeks during the 27 weeks of the study period. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06021379
Study type	Observational
Source	AryoGen Pharmed Co.
Contact
Status	Completed
Phase
Start date	February 22, 2017
Completion date	August 28, 2022

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