Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03433313
Other study ID # EGC002
Secondary ID 2017-003973-33
Status Completed
Phase Phase 3
First received
Last updated
Start date October 16, 2018
Est. completion date January 20, 2022

Study information

Verified date January 2023
Source EirGenix, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this research study is to compare the efficacy and safety of EG12014 with Herceptin as neoadjuvant treatment for 12 weeks, followed by surgery and subsequent EG12014 or Herceptin adjuvant treatment for up to 12 months.


Recruitment information / eligibility

Status Completed
Enrollment 807
Est. completion date January 20, 2022
Est. primary completion date January 20, 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 65 Years
Eligibility 1. Provide signed and dated written informed consent before entering the study. The informed consent will cover both parts of the study (neoadjuvant part and adjuvant part). 2. Female, =18 and =65 years of age. 3. Histologically-confirmed invasive carcinoma of the breast (American Joint Committee on Cancer [AJCC, vs. 8.0] Stage II, IIIa). 4. Operable breast cancer, planned surgical resection of breast tumor (mastectomy or lumpectomy) and sentinel or axillary lymph nodes. 5. Unilateral, measurable tumor of the breast >2 cm in diameter. 6. HER2 positive tumor, defined as 3+ score by IHC or fluorescence positive by FISH, as confirmed by central laboratory. 7. Known estrogen receptor (ER) and progesterone receptor (PrR) status at study entry. 8. Adequate bone marrow function, defined as granulocyte count of =1.500/µL, and platelet count of =100.000/µL. 9. Adequate hepatic and renal function, defined as: bilirubin within normal range alanine aminotransferase (ALT) =2 x upper limit of normal (ULN) aspartate aminotransferase (AST) =2 x ULN gamma glutamyl transferase (GGT) =3 x ULN serum creatinine <1.5 ULN 10. International normalized ratio =1.5×ULN (2 to 3×ULN if on anticoagulants) or prothrombin time =1.5×ULN; activated partial thromboplastin time =1.5×ULN. 11. Hemoglobin concentrations =10 g/dL. 12. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1. 13. LVEF =55%, measured by multiple-gated acquisition (MUGA) scan or echocardiography. 14. Negative pregnancy test at entry, women of childbearing potential have to use contraceptives during the course of the study. Females with childbearing potential must provide a negative serum pregnancy test at Screening and must be using adequate birth control. Adequate birth control is defined as agreement to consistently practice an effective and accepted method of contraception throughout the duration of the study and for 7 months after study drug treatment. These methods include hormonal contraceptives, intrauterine device, or double barrier contraception (i.e., condom + diaphragm) or a male partner with documented vasectomy. Non-childbearing potential is defined as post-menopausal for at least 1 year or surgical sterilization or hysterectomy at least 3 months before study start. Exclusion Criteria: 1. Bilateral breast cancer. 2. Pregnancy or lactation or considering becoming pregnant. 3. Metastases, other than sentinel/axillary lymph nodes. 4. Previous treatment (chemotherapy, biologic therapy, radiation, or surgery) for invasive malignant disease or other concomitant malignancy, other than basal cell carcinoma of the skin. Previous treatment for carcinoma in situ of the cervix is allowed. 5. Previous treatment with Herceptin. 6. Angina pectoris or arrhythmia requiring medication; poorly controlled hypertension; history of myocardial infarction or cardiac failure, New York Heart Association (NYHA) class II or higher; clinically significant cardiac valvular disease; hemodynamic effective pericardial effusion; other cardiomyopathies; LVEF of <55%. 7. Any investigational treatment less than 30 days prior to study entry, or within a time interval less than at least 5 half-lives of the investigational medicinal product, whichever is longer. 8. Positive diagnostic test for hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV). 9. History of hypersensitivity to drugs with similar chemical structures to trastuzumab. 10. History of, or known current problems with, drug or alcohol abuse. 11. Other serious illness, medical disorder or condition that, in the opinion of the Investigator, would make the patient unsuitable for participation in the study.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
EG12014
EG12014 6mg/kg is ongoing to be administered after 8mg/kg loading dose.
Herceptin
Herceptin 6mg/kg is ongoing to be administered after 8mg/kg loading dose.

Locations

Country Name City State
Belarus Brest Regional Oncology Center Brest
Belarus Gomel Regional Clinical Oncology Center Gomel
Belarus N.N. Aleksandrov Republican Research Oncology and Medical Radiology Center Lesnoy
Belarus Minsk City Clinical Oncology Center Minsk
Belarus Mogilev Regional Oncology Center Mogilev
Belarus Vitebsk Regional Clinical Oncology Center Vitebsk
Chile Medical Research Limited Society Temuco
Chile Oncocentro Apys Viña Del Mar
Colombia Clinic Life Foundation Medellín
Colombia Rodrigo Botero SAS Medellín
Georgia LTD High-Tech Hospital MedCenter Batumi
Georgia JSC "Evex Hospitals Kutaisi
Georgia LTD Acad. F. Todua Medical Center - LTD Research Institute of Clinical Medicine Tbilisi
Georgia LTD Aversi Clinic Tbilisi
Georgia LTD Cancer Research Centre Tbilisi
Georgia LTD Health House Tbilisi
Georgia LTD Institute of Clinical Oncology Tbilisi
Georgia LTD S.Khechinashvili University Hospital Tbilisi
Georgia Malkhaz Katsiashvili Multiprofile Emergency Medicine Center Tbilisi
India Cytecare Cancer Hospitals Bengaluru
India King George's Medical University, Department of Endocrine surgery, Shatabdi Phase II Lucknow
India Tata Memorial Centre Mumbai
India HCG NCHRI Cancer Centre Nagpur
India Christian Medical College, Department of Medical Oncology Vellore
Korea, Republic of Keimyung University - Dongsan Medical Center Daegu
Russian Federation Arkhangelsk Clinical Oncology Center Arkhangel'sk
Russian Federation Chelyabinsk Regional Clinical Oncology and Nuclear Medicine Center Chelyabinsk
Russian Federation Evimed, LLC Chelyabinsk
Russian Federation Ivanovo Regional Oncology Center Ivanovo
Russian Federation Republican Clinical Oncology Center Kazan
Russian Federation Krasnoyarsk A.I. Kryzhanovsky Regional Oncology Center Krasnoyarsk
Russian Federation Kursk Regional Clinical Oncology Center Kursk
Russian Federation N.N. Blokhin National Medical Oncology Research Center Moscow
Russian Federation National Medical Research Center for Radiology Moscow
Russian Federation Vitamed" LLC Moscow
Russian Federation A.F.Tsyb Medical Radiology Research Center Obninsk
Russian Federation Clinical Oncology Center Omsk
Russian Federation Pyatigorsk Interdistrict Oncology Center Pyatigorsk
Russian Federation Rostov Oncology Research Institute Rostov-on-Don
Russian Federation Regional Clinical Oncology Center Ryazan'
Russian Federation AV Medical Group Saint Petersburg
Russian Federation City Clinical Oncology Center Saint Petersburg
Russian Federation Clinic "Mart" Saint Petersburg
Russian Federation I.I. Mechnikov North-Western State Medical University Saint Petersburg
Russian Federation Leningrad Regional Oncology Center (Outpatient Department) Saint Petersburg
Russian Federation Leningrad Regional Oncology Center (Surgery Department) Saint Petersburg
Russian Federation N.N. Petrov National Medical Research Center of Oncology Saint Petersburg
Russian Federation Oncology Center of Moskovskiy District Saint Petersburg
Russian Federation Private Medical Institution "EVROMEDSERVIS", Department of Oncology Saint Petersburg
Russian Federation St. Petersburg Clinical Research and Practical Center for Specialized Types of Medical Care (Oncology) Saint Petersburg
Russian Federation Republican Oncology Center Saransk
Russian Federation Oncology Center #2 Sochi
Russian Federation Tomsk National Research Medical Center Tomsk
Russian Federation Regional Clinical Oncology Center Veliky Novgorod
Russian Federation Volgograd Regional Clinical Oncology Center Volgograd
South Africa GVI Oncology, Cape Gate Oncology Centre Cape Town
South Africa The Oncology Centre Durban
South Africa Medical Oncology Centre of Rosebank Johannesburg
South Africa Little Company of Mary Medical Center, Department of Oncology Pretoria
South Africa University of Pretoria, Department of Medical Oncology Pretoria
Taiwan Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung
Taiwan China Medical University Hospital Taichung
Taiwan National Taiwan University Hospital Taipei
Taiwan Taipei Veterans General Hospital Taipei
Taiwan Tri-Service General Hospital Taipei
Taiwan Linkou Chang Gung Memorial Hospital Taoyuan
Ukraine Chernihiv Regional Oncology Center Chernihiv
Ukraine Chernivtsi Regional Clinical Oncology Center Chernivtsi
Ukraine Clinical Oncology Center Dnipro
Ukraine Dnipropetrovsk City Multispecialty Clinical Hospital #4, Department of Chemotherapy Dnipro
Ukraine Prikarpattia Clinical Oncology Center Ivano-Frankivsk
Ukraine Communal Non-profit enterprise "Regional Center of Oncology" Kharkiv
Ukraine State Institution: S.P. Hryhoriev Institute of Medical Radiology under the Ukrainian Academy of Medical Sciences, Department of Clinical Oncology and Hematology Kharkiv
Ukraine Khmelnytskyi Regional Oncology Center Khmelnytskyi
Ukraine Kryvyi Rih Oncology Center, Department of Chemotherapy Kryvyi Rih
Ukraine Kyiv City clinical Hospital #2 Kyiv
Ukraine Kyiv Regional Oncology Center, Department of Mastology Kyiv
Ukraine Medical Center "Verum" Kyiv
Ukraine Medical Center of First Private Clinic Kyiv
Ukraine Volyn Regional Oncology Center, Department of Chemotherapy Luts'k
Ukraine Public Institution under Lviv Regional Council: Lviv Regional Treatment and Diagnostics Oncology Center, Department of Chemotherapy Lviv
Ukraine Mariupol Oncology Center Mariupol
Ukraine Odesa Regional Clinical Hospital, Center for Mastology, Department of Thoracic Surgery Odesa
Ukraine Odesa Regional Oncology Center Odesa
Ukraine Ternopil Regional Clinical Oncology Center, Department of Chemotherapy Ternopil'
Ukraine Central City Clinical Hospital, Department of Oncology and Radiology Uzhhorod
Ukraine Zakarpattia Regional Clinical Oncology Center, Department of Chemotherapy Uzhhorod
Ukraine Podillia Regional Oncology Center Vinnytsia
Ukraine Zhytomyr Regional Oncology Center Zhytomyr
United States Aultman Hospital, Cancer Center Canton Ohio
United States Detroit Clinical Research Center Farmington Hills Michigan

Sponsors (1)

Lead Sponsor Collaborator
EirGenix, Inc.

Countries where clinical trial is conducted

United States,  Belarus,  Chile,  Colombia,  Georgia,  India,  Korea, Republic of,  Russian Federation,  South Africa,  Taiwan,  Ukraine, 

Outcome

Type Measure Description Time frame Safety issue
Primary Determination of pathologic complete response (pCR) at time of surgery pCR is defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled sentinel and/or axillary lymph nodes At the time of surgery (3-6 weeks after completion of neoadjuvant chemotherapy)
Secondary pCR at the time of surgery pCR is defined as the absence of residual invasive cancer and of DICS (ypT0 ypN0) from breast tissue and sentinel/axillary lymph nodes, as assessed by central laboratory At the time of surgery (3-6 weeks after completion of neoadjuvant chemotherapy)
Secondary pCR at the time of surgery pCR is defined as the absence of invasive cancer in breast tissue only (ypT0/is) as assessed by central laboratory At the time of surgery (3-6 weeks after completion of neoadjuvant chemotherapy)
Secondary Event-free survival (EFS) up to end of study (EOS) EFS is defined as time from initial randomization to the date when disease recurrence or progression (local, regional, distant or contralateral) is diagnosed according to institutional standard, or date of death of any cause, whichever is earlier Randomization to date of progression or end of study (up to approximately 24 months or death)
Secondary Overall response (OR) prior to surgery Objective response is defined as partial response (PR) or complete response (CR) according to RECIST v1.1 At screening and prior to surgery (3-6 weeks after completion of neoadjuvant chemotherapy)
Secondary Overall survival (OS) up to End of Study (EOS) OS up to EOS is defined as time from the date of initial randomization to the date of death Randomization to end of study (up to approximately 24 months or death)
Secondary Incidence of AEs Incidence of AEs (including severity, seriousness, and relationship to study drug) and laboratory abnormalities From time of informed consent to end of study (up to approximately 25 months or death)
Secondary Evaluation of Immunogenicity of EG12014 and Herceptin Titer of anti-drug antibodies (ADA) Prior to 1st infusion of study drug, during neoadjuvant treatment, after the last dose of neoadjuvant treatment, during adjuvant treatment, and End of Treatment
Secondary Measure serum trastuzumab concentration Measure serum trastuzumab concentration for EG12014 and Herceptin arms Prior to 1st infusion of study drug, during neoadjuvant treatment after the last dose of neoadjuvant treatment, during adjuvant treatment, and End of Treatment
See also
  Status Clinical Trial Phase
Recruiting NCT04681911 - Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer Phase 2
Completed NCT04890327 - Web-based Family History Tool N/A
Terminated NCT04066790 - Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer Phase 2
Completed NCT03591848 - Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility N/A
Recruiting NCT03954197 - Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients N/A
Terminated NCT02202746 - A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer Phase 2
Active, not recruiting NCT01472094 - The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
Recruiting NCT06057636 - Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study N/A
Recruiting NCT06049446 - Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
Recruiting NCT05560334 - A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations Phase 2
Active, not recruiting NCT05501769 - ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer Phase 1
Recruiting NCT04631835 - Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer Phase 1
Completed NCT04307407 - Exercise in Breast Cancer Survivors N/A
Recruiting NCT03544762 - Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation Phase 3
Terminated NCT02482389 - Study of Preoperative Boost Radiotherapy N/A
Enrolling by invitation NCT00068003 - Harvesting Cells for Experimental Cancer Treatments
Completed NCT00226967 - Stress, Diurnal Cortisol, and Breast Cancer Survival
Recruiting NCT06006390 - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT06019325 - Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy N/A
Recruiting NCT06037954 - A Study of Mental Health Care in People With Cancer N/A