AryoTrust® (Trastuzumab) Safety Study

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06021379
• Other study ID #: TRA.ARY.FH.95.IV
• Status: Completed
• Start date: February 22, 2017
• Est. completion date: August 28, 2022

Study information

• Verified date: August 2023
• Source: AryoGen Pharmed Co.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 597
• Est. completion date: August 28, 2022
• Est. primary completion date: August 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients with HER2-positive breast cancer undergoing adjuvant chemotherapy regimens

Exclusion Criteria:

• Patients who had received Trastuzumab as part of their therapy or were not candidates for treatment continuation after adjuvant chemotherapy

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	5th Azar Hospital	Gorgan
Iran, Islamic Republic of	Milad Hospital	Isfahan
Iran, Islamic Republic of	Mahdieh Clinic	Kermanshah
Iran, Islamic Republic of	Hashemi Nezhad Hospital	Mashhad
Iran, Islamic Republic of	Imam Reza Hospital	Mashhad
Iran, Islamic Republic of	Omid Hospital	Mashhad
Iran, Islamic Republic of	Sadra Clinic	Qom
Iran, Islamic Republic of	Vasei Hospital	Sabzevar
Iran, Islamic Republic of	Namazi Hospital	Shiraz
Iran, Islamic Republic of	Valiasr Hospital	Tabriz
Iran, Islamic Republic of	Imam Hussein Hospital	Tehran
Iran, Islamic Republic of	Mahdiyeh Hospital	Tehran
Iran, Islamic Republic of	Shahid Fayaz-Bakhsh Hospital	Tehran
Iran, Islamic Republic of	Shohadaye Tajrish Hospital	Tehran
Iran, Islamic Republic of	Omid Hospital	Urmía

Sponsors (1)

Lead Sponsor	Collaborator
AryoGen Pharmed Co.

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of safety by incidence, severity, seriousness and causality relationship of reported AEs	Safety assessment, including the incidence of any AEs, laboratory results and assessment of tolerability as evaluated by infusion-related reactions. All AEs were classified based on the Medical Dictionary for Regulatory Activities (MedDRA Desktop Browser 4.0 Beta) terms as System Organ Class (SOC) and Preferred Term (PT). All the reported events were graded according to the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). Moreover, seriousness of AEs was assessed according to International Council for Harmonisation (ICH-E2B) guidelines. The causality relation was assessed based on the World Health Organization (WHO) criteria.	up to 27 weeks