NCT06021379

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
597

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2017

Longer than P75 for all trials

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 22, 2017

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2022

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

August 28, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 1, 2023

Completed
Last Updated

October 31, 2023

Status Verified

August 1, 2023

Enrollment Period

5.5 years

First QC Date

August 28, 2023

Last Update Submit

October 30, 2023

Conditions

Breast Cancer

Keywords

TrastuzumabSafetyAryoTrustBreast CancerAdjuvant Chemotherapy

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

AryoGen Pharmed Trastuzumab

AryoTrust is given at dosing of 6 mg/m2 after adjuvant chemotherapy completion every 3 weeks for 9 cycles.

Drug: Trastuzumab

Interventions

TrastuzumabDRUG

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

Also known as: AryoTrust
AryoGen Pharmed Trastuzumab

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

5th Azar Hospital

Gorgan, Iran

Location

Milad Hospital

Isfahan, Iran

Location

Mahdieh Clinic

Kermanshah, Iran

Location

Hashemi Nezhad Hospital

Mashhad, Iran

Location

Imam Reza Hospital

Mashhad, Iran

Location

Omid Hospital

Mashhad, Iran

Location

Sadra Clinic

Qom, Iran

Location

Vasei Hospital

Sabzawār, Iran

Location

Namazi Hospital

Shiraz, Iran

Location

Valiasr Hospital

Tabriz, Iran

Location

Imam Hussein Hospital

Tehran, Iran

Location

Mahdiyeh Hospital

Tehran, Iran

Location

Shahid Fayaz-Bakhsh Hospital

Tehran, Iran

Location

Shohadaye Tajrish Hospital

Tehran, Iran

Location

Omid Hospital

Urmia, Iran

Location

Related Publications (1)

  • Zahedi F, Jafari A, Nasiri Motlagh B, Hamedi SH, Salek R, Khandoozi S, Farshchian N, Shahidsales S, Mafi AR, Hosseini S, Amouheidari A, Varshoee Tabrizi F, Khanjani N, Ahmadloo N, Dayyani M, Khodabakhshi R, Mojahed MM, Keshvari M, Fazl Ersi M, Mirsadraee M, Izadpanahi P, Saadipoor A, Nasrollahi H, Anbiaee R, Emadi Torghabeh A, Keramati A, Amiran SA, Bayat Mokhtari N, Taghizadeh Kermani A, Anvari K, Sadeghi Ivari M, Dayani M, Amirabadi A, Saeidi Saedi H, Sabzvari A, Kafi H, Homaei Shandiz F. Safety evaluation of the trastuzumab biosimilar in Iranian women with HER2-positive breast cancer undergoing adjuvant chemotherapy: a post-marketing surveillance. Expert Opin Drug Saf. 2024 Aug 1:1-6. doi: 10.1080/14740338.2024.2385483. Online ahead of print.

    PMID: 39076099DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Trastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Fatemeh Homaee Shandiz, Prof.

    Radiooncology Department, school of Medicine, Mashhad University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2023

First Posted

September 1, 2023

Study Start

February 22, 2017

Primary Completion

August 28, 2022

Study Completion

August 28, 2022

Last Updated

October 31, 2023

Record last verified: 2023-08

Locations

IR(15)