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Breast CancerPhase 3NCT03433313

Efficacy and Safety Study of EG12014 Compared With Herceptin in Subjects With HER2 Positive Early Breast Cancer

A Phase 3 study testing EG12014 and Herceptin in people with Breast Cancer, run by EirGenix, Inc. at 91 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
EG12014 and Herceptin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
807 participants
Where
91 sitesin 11 countries
Study dates
16 Oct 2018to 20 Jan 2022
Phase
Phase 3
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 18 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • Bilateral breast cancer.
  • Pregnancy or lactation or considering becoming pregnant.
  • Metastases, other than sentinel/axillary lymph nodes.
  • 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.
  • Previous treatment with Herceptin.
  • 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%.
Show all 11Show fewer
  • 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.
  • Positive diagnostic test for hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV).
  • History of hypersensitivity to drugs with similar chemical structures to trastuzumab.
  • History of, or known current problems with, drug or alcohol abuse.
  • Other serious illness, medical disorder or condition that, in the opinion of the Investigator, would make the patient unsuitable for participation in the study.

Trial locations and contacts

91 sites in 11 countries.

91 sites in 11 countries

Russia30 sites

  • Arkhangelsk Clinical Oncology Center

    Arkhangelsk

  • Chelyabinsk Regional Clinical Oncology and Nuclear Medicine Center

    Chelyabinsk

  • Evimed, LLC

    Chelyabinsk

  • Ivanovo Regional Oncology Center

    Ivanovo

  • Republican Clinical Oncology Center

    Kazan'

  • Krasnoyarsk A.I. Kryzhanovsky Regional Oncology Center

    Krasnoyarsk

  • Kursk Regional Clinical Oncology Center

    Kursk

  • N.N. Blokhin National Medical Oncology Research Center

    Moscow

  • National Medical Research Center for Radiology

    Moscow

  • Vitamed" LLC

    Moscow

  • A.F.Tsyb Medical Radiology Research Center

    Obninsk

  • Clinical Oncology Center

    Omsk

  • Pyatigorsk Interdistrict Oncology Center

    Pyatigorsk

  • Rostov Oncology Research Institute

    Rostov-on-Don

  • Regional Clinical Oncology Center

    Ryazan

  • AV Medical Group

    Saint Petersburg

  • City Clinical Oncology Center

    Saint Petersburg

  • Clinic "Mart"

    Saint Petersburg

  • I.I. Mechnikov North-Western State Medical University

    Saint Petersburg

  • Leningrad Regional Oncology Center (Outpatient Department)

    Saint Petersburg

  • Leningrad Regional Oncology Center (Surgery Department)

    Saint Petersburg

  • N.N. Petrov National Medical Research Center of Oncology

    Saint Petersburg

  • Oncology Center of Moskovskiy District

    Saint Petersburg

  • Private Medical Institution "EVROMEDSERVIS", Department of Oncology

    Saint Petersburg

  • St. Petersburg Clinical Research and Practical Center for Specialized Types of Medical Care (Oncology)

    Saint Petersburg

  • Republican Oncology Center

    Saransk

  • Oncology Center #2

    Sochi

  • Tomsk National Research Medical Center

    Tomsk

  • Regional Clinical Oncology Center

    Velikiy Novgorod

  • Volgograd Regional Clinical Oncology Center

    Volgograd

Other trials in Russia

Ukraine23 sites

  • Chernihiv Regional Oncology Center

    Chernihiv

  • Chernivtsi Regional Clinical Oncology Center

    Chernivtsi

  • Clinical Oncology Center

    Dnipro

  • Dnipropetrovsk City Multispecialty Clinical Hospital #4, Department of Chemotherapy

    Dnipro

  • Prikarpattia Clinical Oncology Center

    Ivano-Frankivsk

  • Communal Non-profit enterprise "Regional Center of Oncology"

    Kharkiv

  • State Institution: S.P. Hryhoriev Institute of Medical Radiology under the Ukrainian Academy of Medical Sciences, Department of Clinical Oncology and Hematology

    Kharkiv

  • Khmelnytskyi Regional Oncology Center

    Khmelnytskyi

  • Kryvyi Rih Oncology Center, Department of Chemotherapy

    Kryvyi Rih

  • Kyiv City clinical Hospital #2

    Kyiv

  • Kyiv Regional Oncology Center, Department of Mastology

    Kyiv

  • Medical Center "Verum"

    Kyiv

  • Medical Center of First Private Clinic

    Kyiv

  • Volyn Regional Oncology Center, Department of Chemotherapy

    Lutsk

  • Public Institution under Lviv Regional Council: Lviv Regional Treatment and Diagnostics Oncology Center, Department of Chemotherapy

    Lviv

  • Mariupol Oncology Center

    Mariupol

  • Odesa Regional Clinical Hospital, Center for Mastology, Department of Thoracic Surgery

    Odesa

  • Odesa Regional Oncology Center

    Odesa

  • Ternopil Regional Clinical Oncology Center, Department of Chemotherapy

    Ternopil

  • Central City Clinical Hospital, Department of Oncology and Radiology

    Uzhhorod

  • Zakarpattia Regional Clinical Oncology Center, Department of Chemotherapy

    Uzhhorod

  • Podillia Regional Oncology Center

    Vinnytsia

  • Zhytomyr Regional Oncology Center

    Zhytomyr

Other trials in Ukraine

Georgia9 sites

  • LTD High-Tech Hospital MedCenter

    Batumi

  • JSC "Evex Hospitals

    Kutaisi

  • LTD Acad. F. Todua Medical Center - LTD Research Institute of Clinical Medicine

    Tbilisi

  • LTD Aversi Clinic

    Tbilisi

  • LTD Cancer Research Centre

    Tbilisi

  • LTD Health House

    Tbilisi

  • LTD Institute of Clinical Oncology

    Tbilisi

  • LTD S.Khechinashvili University Hospital

    Tbilisi

  • Malkhaz Katsiashvili Multiprofile Emergency Medicine Center

    Tbilisi

Other trials in Georgia

Belarus6 sites

  • Brest Regional Oncology Center

    Brest

  • Gomel Regional Clinical Oncology Center

    Homyel

  • N.N. Aleksandrov Republican Research Oncology and Medical Radiology Center

    Lesnoy

  • Minsk City Clinical Oncology Center

    Minsk

  • Mogilev Regional Oncology Center

    Mogilev

  • Vitebsk Regional Clinical Oncology Center

    Vitebsk

Other trials in Belarus

Taiwan6 sites

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City

  • China Medical University Hospital

    Taichung

  • National Taiwan University Hospital

    Taipei

  • Taipei Veterans General Hospital

    Taipei

  • Tri-Service General Hospital

    Taipei

  • Linkou Chang Gung Memorial Hospital

    Taoyuan

Other trials in Taiwan

India5 sites

  • Cytecare Cancer Hospitals

    Bengaluru

  • King George's Medical University, Department of Endocrine surgery, Shatabdi Phase II

    Lucknow

  • Tata Memorial Centre

    Mumbai

  • HCG NCHRI Cancer Centre

    Nagpur

  • Christian Medical College, Department of Medical Oncology

    Vellore

Other trials in India

South Africa5 sites

  • GVI Oncology, Cape Gate Oncology Centre

    Cape Town

  • The Oncology Centre

    Durban

  • Medical Oncology Centre of Rosebank

    Johannesburg

  • Little Company of Mary Medical Center, Department of Oncology

    Pretoria

  • University of Pretoria, Department of Medical Oncology

    Pretoria

Other trials in South Africa

United States2 sites

  • Aultman Hospital, Cancer Center

    Canton, Ohio, 44718

  • Detroit Clinical Research Center

    Farmington Hills, Michigan, 48334

Other trials in United States

Chile2 sites

  • Medical Research Limited Society

    Temuco

  • Oncocentro Apys

    Viña del Mar

Other trials in Chile

Colombia2 sites

  • Clinic Life Foundation

    Medellín

  • Rodrigo Botero SAS

    Medellín

Other trials in Colombia

South Korea1 site

  • Keimyung University - Dongsan Medical Center

    Daegu

Other trials in South Korea

About this study

Official title: A Phase III, Randomized, Multicenter, Double-blind Study to Compare Efficacy and Safety of EG12014 With Herceptin as Neoadjuvant Treatment in Combination With Anthracycline/Paclitaxel Systemic Therapy in HER2-Positive Early Breast Cancer

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.

Conditions
Breast Cancer
Being tested
EG12014, Herceptin
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EG12014Drug

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

  • HerceptinDrug

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

Study groups in NCT03433313
Study groupRoleWhat they receive
EG12014ExperimentalEpirubicin and cyclophosphamide followed by EG12014 plus paclitaxel. All patients will be scheduled for surgery (breast and axillary lymph nodes) at 3 to 6 weeks after completion of neoadjuvant chemotherapy.
Receives: Drug: EG12014
HerceptinActive comparatorEpirubicin and cyclophosphamide followed by Herceptin plus paclitaxel. All patients will be scheduled for surgery (breast and axillary lymph nodes) at 3 to 6 weeks after completion of neoadjuvant chemotherapy.
Receives: Drug: Herceptin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: At the time of surgery (3-6 weeks after completion of neoadjuvant chemotherapy)

Secondary outcomes (8)

  1. 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

    Measured: At the time of surgery (3-6 weeks after completion of neoadjuvant chemotherapy)

  2. 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

    Measured: At the time of surgery (3-6 weeks after completion of neoadjuvant chemotherapy)

  3. 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

    Measured: Randomization to date of progression or end of study (up to approximately 24 months or death)

  4. Overall response (OR) prior to surgery

    Objective response is defined as partial response (PR) or complete response (CR) according to RECIST v1.1

    Measured: At screening and prior to surgery (3-6 weeks after completion of neoadjuvant chemotherapy)

  5. 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

    Measured: Randomization to end of study (up to approximately 24 months or death)

  6. Incidence of AEs

    Incidence of AEs (including severity, seriousness, and relationship to study drug) and laboratory abnormalities

    Measured: From time of informed consent to end of study (up to approximately 25 months or death)

  7. Evaluation of Immunogenicity of EG12014 and Herceptin

    Titer of anti-drug antibodies (ADA)

    Measured: Prior to 1st infusion of study drug, during neoadjuvant treatment, after the last dose of neoadjuvant treatment, during adjuvant treatment, and End of Treatment

  8. Measure serum trastuzumab concentration

    Measure serum trastuzumab concentration for EG12014 and Herceptin arms

    Measured: Prior to 1st infusion of study drug, during neoadjuvant treatment after the last dose of neoadjuvant treatment, during adjuvant treatment, and End of Treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Feb 2018
  2. Study start16 Oct 2018
  3. Primary completion20 Jan 2022
  4. Study completion20 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
807 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03433313
Sponsor's protocol ID
EGC002
Other IDs
2017-003973-33, 2017
Status last verified
Jan 2023
First submitted
8 Feb 2018
Last updated
20 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Huang CS, Dzagnidze G, Grohmann-Izay B, Liu LC, Llinas-Quintero N, Lin AN, Mishra AK, Pominchuk D, Prokharau A, Rapoport BL, Semiglazov V, Tseng LM, Ruiz EY, Loibl S. Efficacy and Safety of EG12014 (Biosimilar Trastuzumab) Compared to Reference Trastuzumab in HER2-Positive Early Breast Cancer: A Phase III Randomized Study. Adv Ther. 2026 Sep 24. doi: 10.1007/s12325-026-03781-3. Online ahead of print.

    PubMed 42782448

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing EG12014 and Herceptin in people with Breast Cancer, run by EirGenix, Inc. at 91 sites in 11 countries.

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 0 inclusion and 11 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 20 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 91 sites in Russia, Ukraine, Georgia, Belarus, Taiwan and 6 more countries. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Determination of pathologic complete response (pCR) at time of surgery (time frame: At the time of surgery (3-6 weeks after completion of neoadjuvant chemotherapy)). 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 NCT03433313, 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 20 Jan 2023; AzTrials last refreshed its copy on 7 Nov 2026.

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