AryoTrust® (Trastuzumab) Safety Study
- Registration Number
- NCT06021379
- Lead Sponsor
- AryoGen Pharmed Co.
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 597
- Patients with HER2-positive breast cancer undergoing adjuvant chemotherapy regimens
- Patients who had received Trastuzumab as part of their therapy or were not candidates for treatment continuation after adjuvant chemotherapy
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description AryoGen Pharmed Trastuzumab Trastuzumab AryoTrust is given at dosing of 6 mg/m2 after adjuvant chemotherapy completion every 3 weeks for 9 cycles.
- Primary Outcome Measures
Name Time Method Evaluation of safety by incidence, severity, seriousness and causality relationship of reported AEs 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (14)
Hashemi Nezhad Hospital
🇮🇷Mashhad, Iran, Islamic Republic of
Imam Reza Hospital
🇮🇷Mashhad, Iran, Islamic Republic of
Shahid Fayaz-Bakhsh Hospital
🇮🇷Tehran, Iran, Islamic Republic of
Mahdieh Clinic
🇮🇷Kermanshah, Iran, Islamic Republic of
Shohadaye Tajrish Hospital
🇮🇷Tehran, Iran, Islamic Republic of
Milad Hospital
🇮🇷Isfahan, Iran, Islamic Republic of
Omid Hospital
🇮🇷Urmía, 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
Imam Hussein Hospital
🇮🇷Tehran, Iran, Islamic Republic of
5th Azar Hospital
🇮🇷Gorgān, Iran, Islamic Republic of
Valiasr Hospital
🇮🇷Tabriz, Iran, Islamic Republic of
Mahdiyeh Hospital
🇮🇷Tehran, Iran, Islamic Republic of