NCT06021379

AryoTrust® (Trastuzumab) Safety Study

Post-marketing Surveillance for Evaluation of AryoTrust Safety in Iranian HER2-positive Breast Cancer Patients Undergoing Adjuvant Chemotherapy Regimens

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 597 (actual)
• Sponsor: AryoGen Pharmed Co. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Trastuzumab	AryoTrust (AryoGen Pharmed Trastuzumab) is given at a dosing of 6 mg/m2 after adjuvant chemotherapy completion every 3 weeks for 9 cycles.

Timeline

• Start date: 2017-02-22
• Primary completion: 2022-08-28
• Completion: 2022-08-28
• First posted: 2023-09-01
• Last updated: 2023-10-31

Locations

15 sites across 1 country: Iran