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AryoTrust® (Trastuzumab) Safety Study

NCT06021379 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 597

Last updated 2023-10-31

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Trastuzumab

AryoTrust (AryoGen Pharmed Trastuzumab) is given at a dosing of 6 mg/m2 after adjuvant chemotherapy completion every 3 weeks for 9 cycles.

Sponsors & Collaborators

  • AryoGen Pharmed Co.

    lead INDUSTRY

Principal Investigators

  • Fatemeh Homaee Shandiz, Prof. · Radiooncology Department, school of Medicine, Mashhad University of Medical Sciences

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-22
Primary Completion
2022-08-28
Completion
2022-08-28

Countries

  • Iran

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06021379 on ClinicalTrials.gov