AryoTrust® (Trastuzumab) Safety Study

AryoGen Pharmed

Status: Completed

Conditions: Breast Cancer

Treatments: Drug: Trastuzumab

Study type: Observational

Funder types: Industry

Identifiers

NCT06021379

TRA.ARY.FH.95.IV

Details and patient eligibility

About

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.

Full 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.

Enrollment: 597 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

597 participants in 1 patient group

AryoGen Pharmed Trastuzumab

Description:

AryoTrust is given at dosing of 6 mg/m2 after adjuvant chemotherapy completion every 3 weeks for 9 cycles.

Treatment:

Drug: Trastuzumab