Clinical trial NCT06021379: AryoTrust® (Trastuzumab) Safety Study
Official title: Post-marketing Surveillance for Evaluation of AryoTrust Safety in Iranian HER2-positive Breast Cancer Patients Undergoing Adjuvant Chemotherapy Regimens
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Trastuzumab
Safety
AryoTrust
Breast Cancer
Adjuvant Chemotherapy
Lead sponsor: AryoGen Pharmed Co.
Sponsor class: INDUSTRY
First posted: 2023-09-01
Enrollment: 597
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of safety by incidence, severity, seriousness and causality relationship of reported AEs
timeFrame: up to 27 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Gorgān
country: Iran, Islamic Republic of
facility: 5th Azar Hospital
city: Isfahan
country: Iran, Islamic Republic of
facility: Milad Hospital
city: Kermanshah
country: Iran, Islamic Republic of
facility: Mahdieh Clinic
city: Mashhad
country: Iran, Islamic Republic of
facility: Hashemi Nezhad Hospital
city: Mashhad
country: Iran, Islamic Republic of
facility: Imam Reza Hospital
city: Mashhad
country: Iran, Islamic Republic of
facility: Omid Hospital
city: Qom
country: Iran, Islamic Republic of
facility: Sadra Clinic
city: Sabzevar
country: Iran, Islamic Republic of
facility: Vasei Hospital
city: Shiraz
country: Iran, Islamic Republic of
facility: Namazi Hospital
city: Tabriz
country: Iran, Islamic Republic of
facility: Valiasr Hospital
city: Tehran
country: Iran, Islamic Republic of
facility: Imam Hussein Hospital
city: Tehran
country: Iran, Islamic Republic of
facility: Mahdiyeh Hospital
city: Tehran
country: Iran, Islamic Republic of
facility: Shahid Fayaz-Bakhsh Hospital
city: Tehran
country: Iran, Islamic Republic of
facility: Shohadaye Tajrish Hospital
city: Urmía
country: Iran, Islamic Republic of
facility: Omid Hospital
Study officials:
affiliation: Radiooncology Department, school of Medicine, Mashhad University of Medical Sciences
name: Fatemeh Homaee Shandiz, Prof.
role: PRINCIPAL_INVESTIGATOR
References: