Comparing Efficacy and Safety of AryoGen Pharmed Biosimilar Trastuzumab (AryoTrust) Versus Herceptin® in Breast Cancer

NCT03425656 | Completed Phase 3 Results DMC

• 1 other identifier: TRA.ARY.RS.95 (III)
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 19

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 (Aryogen Trastuzumab in comparison to Herceptin® (Genentech/Roche) in patients with Human Epidermal Growth Factor Receptor 2-Positive breast cancer. The main objective is to verify the non-inferiority of AryoTrust (Aryogen trastuzumab) vs. Herceptin® (Genentech/Roche trastuzumab), both given concomitantly with docetaxel after doxorubicin plus cyclophosphamide in the neoadjuvant setting according to pathological complete response (pCR) as primary objective and objective response (cOR), clinical complete response (cCR), clinical partial response (cPR), clinical stable disease (cSD), clinical progressive disease (cPD), breast conservation rate as Secondary objectives of this study. Evaluating the safety and immunogenicity of AryoTrust vs. Herceptin®, are also the other secondary outcomes. This study has two arms and 108 subjects will participate with a 1:1 allocation and receive mentioned treatment randomly.

Conditions

Malignant Neoplasm of Breast

Keywords

breast cancer; AryoTrust; Herceptin®; non-Inferiority

Outcome Measures

Primary Outcomes (1)

• Pathologic Complete Response

  the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes

  week 23

Secondary Outcomes (4)

• Clinical Objective Response

  week 21

• Breast Conservation Rate

  week 23

• Safety Assessment by Evaluation of Adverse Events (AEs) and Abnormal Laboratory Results

  up to week 26

• The Number of Participants With Anti-drug Antibodies Against Trastuzumab (AryoTrust)

  week 10, week 13, week 19, week 26

Study Arms (2)

Trastuzumab (AryoTrust)

EXPERIMENTAL

Trastuzumab (AryoTrust) is given concomitantly with docetaxel (for four 21-day cycles) after four 14-day cycles of Doxorubicin plus cyclophosphamide

Drug: Trastuzumab plus docetaxel (for four 21-day cycles) after four 14-day cycles of Doxorubicin plus cyclophosphamide

Trastuzumab (Herceptin)

ACTIVE COMPARATOR

Trastuzumab (Herceptin) is given concomitantly with docetaxel (for four 21-day cycles) after four 14-day cycles of Doxorubicin plus cyclophosphamide

Drug: Trastuzumab plus docetaxel (for four 21-day cycles) after four 14-day cycles of Doxorubicin plus cyclophosphamide

Interventions

Trastuzumab plus docetaxel (for four 21-day cycles) after four 14-day cycles of Doxorubicin plus cyclophosphamide DRUG

Trastuzumab (8 mg/kg IV loading dose at cycle 1, followed by 6 mg/kg at subsequent cycles) is given concomitantly with docetaxel (100 mg/m2 IV) for four 21-day cycles after four 14-day cycles of Doxorubicin (60 mg/m2 IV) plus cyclophosphamide (600 mg/m2 IV)

Trastuzumab (AryoTrust); Trastuzumab (Herceptin)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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+)).

You may not qualify if:

• 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

Sponsors & Collaborators

• AryoGen Pharmed Co.: lead

Study Sites (19)

Shafa Hospital

Ahvāz, Iran

Location

Sheikh Mofid Clinic

Isfahan, Iran

Location

Javadol Aemeh Clinic

Kerman, Iran

Location

Park clinic

Kerman, Iran

Location

Payandeh Clinic

Kermanshah, Iran

Location

Imam Reza Hospital

Mashhad, Iran

Location

Tohid Hospital

Sanandaj, Iran

Location

Shahid Faqihi Hospital

Shiraz, Iran

Location

Baqiatallah Hospital

Tehran, Iran

Location

Booali Hospital

Tehran, Iran

Location

Firoozgar Hospital

Tehran, Iran

Location

Imam Khomeini hospital

Tehran, Iran

Location

Jahad Daneshgahi Clinic

Tehran, Iran

Location

Masood Clinic

Tehran, Iran

Location

Mehrad Hospital

Tehran, Iran

Location

Rasool Akram Hospital

Tehran, Iran

Location

Toos Hospital

Tehran, Iran

Location

Mortazavizadeh Clinic

Yazd, Iran

Location

Aliebne Abitaleb Hospital

Zahedan, Iran

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Trastuzumab; Docetaxel; Cyclophosphamide

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds

Results Point of Contact

• Title: Dr. Reza Safaei, M.D
• Organization: Imam Khomeini Hospital, Tehran University of Medical Sciences, Tehran, Iran.

safaiino@sina.tums.ac.ir

0098-9124548684

Study Officials

• Reza Safaei, M.D

  Tehran University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2017
• First Posted: February 7, 2018
• Study Start: July 9, 2016
• Primary Completion: March 6, 2018
• Study Completion: August 5, 2018
• Last Updated: June 28, 2024
• Results First Posted: June 28, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

IR (19)