AryoTrust® (Trastuzumab) Safety Study

October 30, 2023 updated by: AryoGen Pharmed Co.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

597

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran, Islamic Republic of
      • Gorgān, Iran, Islamic Republic of
        • 5th Azar Hospital
      • Isfahan, Iran, Islamic Republic of
        • Milad Hospital
      • Kermanshah, Iran, Islamic Republic of
        • Mahdieh Clinic
      • Mashhad, Iran, Islamic Republic of
        • Imam Reza Hospital
      • Mashhad, Iran, Islamic Republic of
        • Hashemi Nezhad Hospital
      • Mashhad, Iran, Islamic Republic of
        • Omid Hospital
      • Qom, Iran, Islamic Republic of
        • Sadra Clinic
      • Sabzevar, Iran, Islamic Republic of
        • Vasei Hospital
      • Shiraz, Iran, Islamic Republic of
        • Namazi Hospital
      • Tabriz, Iran, Islamic Republic of
        • Valiasr Hospital
      • Tehran, 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
      • Urmía, Iran, Islamic Republic of
        • Omid Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

A total of 597 Iranian patients diagnosed with HER2-positive breast cancer who underwent adjuvant chemotherapy regimens with AryoTrust were enrolled in the study.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
AryoGen Pharmed Trastuzumab
AryoTrust is given at dosing of 6 mg/m2 after adjuvant chemotherapy completion every 3 weeks for 9 cycles.
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.
Other Names:
  • AryoTrust

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of safety by incidence, severity, seriousness and causality relationship of reported AEs
Time Frame: up to 27 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AryoGen Pharmed Co.

Investigators

  • Principal Investigator: Fatemeh Homaee Shandiz, Prof., Radiooncology Department, school of Medicine, Mashhad University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 22, 2017

Primary Completion (Actual)

August 28, 2022

Study Completion (Actual)

August 28, 2022

Study Registration Dates

First Submitted

August 28, 2023

First Submitted That Met QC Criteria

August 28, 2023

First Posted (Actual)

September 1, 2023

Study Record Updates

Last Update Posted (Actual)

October 31, 2023

Last Update Submitted That Met QC Criteria

October 30, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRA.ARY.FH.95.IV

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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