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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AryoGen Pharmed Trastuzumab | AryoTrust is given at dosing of 6 mg/m2 after adjuvant chemotherapy completion every 3 weeks for 9 cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trastuzumab | Drug | AryoTrust (AryoGen Pharmed Trastuzumab) is given at a dosing of 6 mg/m2 after adjuvant chemotherapy completion every 3 weeks for 9 cycles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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A total of 597 Iranian patients diagnosed with HER2-positive breast cancer who underwent adjuvant chemotherapy regimens with AryoTrust were enrolled in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Fatemeh Homaee Shandiz, Prof. | Radiooncology Department, school of Medicine, Mashhad University of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 5th Azar Hospital | Gorgan | Iran | ||||
| Milad Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39076099 | Derived | 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. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000068878 | Trastuzumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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|
| Isfahan |
| Iran |
| Mahdieh Clinic | Kermanshah | Iran |
| Hashemi Nezhad Hospital | Mashhad | Iran |
| Imam Reza Hospital | Mashhad | Iran |
| Omid Hospital | Mashhad | Iran |
| Sadra Clinic | Qom | Iran |
| Vasei Hospital | Sabzawār | Iran |
| Namazi Hospital | Shiraz | Iran |
| Valiasr Hospital | Tabriz | Iran |
| Imam Hussein Hospital | Tehran | Iran |
| Mahdiyeh Hospital | Tehran | Iran |
| Shahid Fayaz-Bakhsh Hospital | Tehran | Iran |
| Shohadaye Tajrish Hospital | Tehran | Iran |
| Omid Hospital | Urmia | Iran |
| D017437 |
| Skin and Connective Tissue Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |