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
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
-
-
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Gorgān, Iran, Islamic Republic of
- 5th Azar Hospital
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Isfahan, Iran, Islamic Republic of
- Milad Hospital
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Kermanshah, Iran, Islamic Republic of
- Mahdieh Clinic
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Mashhad, Iran, Islamic Republic of
- Imam Reza Hospital
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Mashhad, Iran, Islamic Republic of
- Hashemi Nezhad Hospital
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Mashhad, Iran, Islamic Republic of
- Omid Hospital
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Qom, Iran, Islamic Republic of
- Sadra Clinic
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Sabzevar, Iran, Islamic Republic of
- Vasei Hospital
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Shiraz, Iran, Islamic Republic of
- Namazi Hospital
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Tabriz, Iran, Islamic Republic of
- Valiasr Hospital
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Tehran, Iran, Islamic Republic of
- Imam Hussein Hospital
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Tehran, Iran, Islamic Republic of
- Mahdiyeh Hospital
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Tehran, Iran, Islamic Republic of
- Shahid Fayaz-Bakhsh Hospital
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Tehran, Iran, Islamic Republic of
- Shohadaye Tajrish Hospital
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Urmía, Iran, Islamic Republic of
- Omid Hospital
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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.
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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:
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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
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
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.