Status:
COMPLETED
Comparing Efficacy and Safety of AryoGen Pharmed Biosimilar Trastuzumab (AryoTrust) Versus Herceptin® in Breast Cancer
Lead Sponsor:
AryoGen Pharmed Co.
Conditions:
Malignant Neoplasm of Breast
Eligibility:
FEMALE
18-70 years
Phase:
PHASE3
Brief Summary
This is A Phase III, randomized, two-armed, patient-outcome assessor-data analyzer blinded, parallel active controlled non-Inferiority clinical trial study to evaluate efficacy and safety of AryoTrust...
Detailed Description
This is A Phase III, randomized, two-armed, patient-outcome assessor-data analyzer blinded, parallel active controlled non-Inferiority clinical trial study to evaluate efficacy and safety of AryoTrust...
Eligibility Criteria
Inclusion
- 18-70 years old female patients
- Patients with newly diagnosed stage III (locally advanced) or inoperable stage II (due to sizes larger than 5 cm or high tumor to breast ratio) tumors are candidates for participation.
- Willing and able to sign an informed consent
- Pathological diagnosis of adenocarcinoma of the breast
- ECOG status of 0-1
- With any ER/PR status
- HER2 positive (Immunohistochemical (IHC) 3+ intensity, amplification of the HER2 gene on fluorescence in situ hybridization (FISH+ ) or HER2 positive results of Chromogenic in situ hybridization (CISH+)).
Exclusion
- Clinical or radiologic evidence of metastatic disease
- History of any other malignancy including previous breast cancer, second non-breast malignant disease
- History of previous chemotherapy
- Left ventricular ejection fraction \[LVEF\] \<55% confirmed by echo cardiogram within 3 months before registration, Any prior myocardial infarction, History of documented congestive heart failure (CHF),Any prior history of arrhythmia or cardiac valvular disease requiring medications or clinically significant, Current use of medications for treatment of angina pectoris, Current uncontrolled hypertension (diastolic \> 100 mmHg or systolic \> 200 mmHg), A severe conduction abnormality (having pacemaker or diagnosed by the ECG) and any other significant cardiovascular disease.
- Hematologic abnormalities including baseline Absolute Neutrophil Count (ANC) of ≤1,500/µL or platelet count ≤ 100,000/µL
- Liver dysfunction including : (baseline)
- Alanine amino transferase (ALT) and/or aspartate amino transferase (AST) ≥ 3 Upper Limit Normal (ULN)
- Alkaline phosphatase (ALP) ≥3 ͯ ULN
- serum total bilirubin \> 1.5 ULN
- Renal dysfunction, defined as serum creatinine ≥2.5 mg/dL
- Pregnant, lactating women or women of childbearing potential who are not willing to use adequate contraception
Key Trial Info
Start Date :
July 9 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 5 2018
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT03425656
Start Date
July 9 2016
End Date
August 5 2018
Last Update
June 28 2024
Active Locations (19)
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1
Shafa Hospital
Ahvāz, Iran
2
Sheikh Mofid Clinic
Isfahan, Iran
3
Javadol Aemeh Clinic
Kerman, Iran
4
Park clinic
Kerman, Iran