Breast CancerNCT06021379
AryoTrust® (Trastuzumab) Safety Study
An observational study of Breast Cancer, run by AryoGen Pharmed Co. at 15 sites in Iran.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Trastuzumab
- How many people
- 597 participants
- Where
- 15 sitesIran
- Study dates
- 22 Feb 2017to 28 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Patients with HER2-positive breast cancer undergoing adjuvant chemotherapy regimens
Who cannot join
- Patients who had received Trastuzumab as part of their therapy or were not candidates for treatment continuation after adjuvant chemotherapy
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Iran15 sites
5th Azar Hospital
Gorgan
Milad Hospital
Isfahan
Mahdieh Clinic
Kermanshah
Hashemi Nezhad Hospital
Mashhad
Imam Reza Hospital
Mashhad
Omid Hospital
Mashhad
Sadra Clinic
Qom
Vasei Hospital
Sabzawār
Namazi Hospital
Shiraz
Valiasr Hospital
Tabriz
Imam Hussein Hospital
Tehran
Mahdiyeh Hospital
Tehran
Shahid Fayaz-Bakhsh Hospital
Tehran
Shohadaye Tajrish Hospital
Tehran
Omid Hospital
Urmia
About this study
Official title: Post-marketing Surveillance for Evaluation of AryoTrust Safety in Iranian HER2-positive Breast Cancer Patients Undergoing Adjuvant Chemotherapy Regimens
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Trastuzumab
- Keywords
- Trastuzumab, Safety, AryoTrust, Breast Cancer, Adjuvant Chemotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrastuzumabDrug
Also called AryoTrust
AryoTrust (AryoGen Pharmed Trastuzumab) is given at a dosing of 6 mg/m2 after adjuvant chemotherapy completion every 3 weeks for 9 cycles.
| Study group | Role | What they receive |
|---|---|---|
| AryoGen Pharmed Trastuzumab | AryoTrust is given at dosing of 6 mg/m2 after adjuvant chemotherapy completion every 3 weeks for 9 cycles. Receives: Drug: Trastuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 27 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2023
- Study start22 Feb 2017
- Primary completion28 Aug 2022
- Study completion28 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 597 participants (actual)
Sponsor and investigators
- Lead sponsor
- AryoGen Pharmed Co.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fatemeh Homaee Shandiz, Prof., Principal investigator, Radiooncology Department, school of Medicine, Mashhad University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06021379
- Sponsor's protocol ID
- TRA.ARY.FH.95.IV
- Status last verified
- Aug 2023
- First submitted
- 28 Aug 2023
- Last updated
- 31 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39076099
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-marketing Surveillance for Evaluation of AryoTrust Safety in Iranian HER2-positive Breast Cancer Patients Undergoing Adjuvant Chemotherapy Regimens
- ClinicalTrials.gov ID
- NCT06021379
- Acronym / sponsor ID
- TRA.ARY.FH.95.IV
- Conditions
- Breast Cancer
- Keywords
- Trastuzumab, Safety, AryoTrust, Breast Cancer, Adjuvant Chemotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 597 participants (actual)
- Lead sponsor
- AryoGen Pharmed Co.Industry (pharma, biotech, devices)
- Study start
- 22 Feb 2017 (actual)
- Primary completion
- 28 Aug 2022 (actual)
- Study completion
- 28 Aug 2022 (actual)
- First posted
- 1 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AryoGen Pharmed Trastuzumab | – | Drug: TrastuzumabAryoTrust is given at dosing of 6 mg/m2 after adjuvant chemotherapy completion every 3 weeks for 9 cycles. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients with HER2-positive breast cancer undergoing adjuvant chemotherapy regimens
Key exclusion criteria (1 listed)
- Patients who had received Trastuzumab as part of their therapy or were not candidates for treatment continuation after adjuvant chemotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TrastuzumabAlso: AryoTrustAryoTrust (AryoGen Pharmed Trastuzumab) is given at a dosing of 6 mg/m2 after adjuvant chemotherapy completion every 3 weeks for 9 cycles. | Drug | AryoGen Pharmed Trastuzumab |
Primary outcome
Evaluation of safety by incidence, severity, seriousness and causality relationship of reported AEs
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Derived from this study: PubMed 39076099Zahedi 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fatemeh Homaee Shandiz, Prof. principal investigator
Radiooncology Department, school of Medicine, Mashhad University of Medical Sciences
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by AryoGen Pharmed Co. at 15 sites in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of safety by incidence, severity, seriousness and causality relationship of reported AEs (time frame: up to 27 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06021379, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2023; AzTrials last refreshed its copy on 26 Oct 2026.