Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
597 participants
OBSERVATIONAL
2017-02-22
2022-08-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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AryoGen Pharmed Trastuzumab
AryoTrust is given at dosing of 6 mg/m2 after adjuvant chemotherapy completion every 3 weeks for 9 cycles.
Trastuzumab
AryoTrust (AryoGen Pharmed Trastuzumab) is given at a dosing of 6 mg/m2 after adjuvant chemotherapy completion every 3 weeks for 9 cycles.
Interventions
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Trastuzumab
AryoTrust (AryoGen Pharmed Trastuzumab) is given at a dosing of 6 mg/m2 after adjuvant chemotherapy completion every 3 weeks for 9 cycles.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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AryoGen Pharmed Co.
INDUSTRY
Responsible Party
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Principal Investigators
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Fatemeh Homaee Shandiz, Prof.
Role: PRINCIPAL_INVESTIGATOR
Radiooncology Department, school of Medicine, Mashhad University of Medical Sciences
Locations
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5th Azar Hospital
Gorgan, , Iran
Milad Hospital
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
Countries
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References
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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.
Other Identifiers
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TRA.ARY.FH.95.IV
Identifier Type: -
Identifier Source: org_study_id
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