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

NCT03433313 | Completed Phase 3 FDA Drug

• 2 other identifiers: EGC0022017-003973-33
• Study Type: interventional
• Target: 807
• Locations: 11 countries
• Sites: 91

Brief 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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (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

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

Secondary Outcomes (8)

• pCR at the time of surgery

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

• pCR at the time of surgery

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

• Event-free survival (EFS) up to end of study (EOS)

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

• Overall response (OR) prior to surgery

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

• Overall survival (OS) up to End of Study (EOS)

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

Study Arms (2)

EG12014

EXPERIMENTAL

Epirubicin 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.

Drug: EG12014

Herceptin

ACTIVE COMPARATOR

Epirubicin 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.

Drug: Herceptin

Interventions

EG12014 DRUG

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

EG12014

Herceptin DRUG

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

Herceptin

Eligibility Criteria

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

You may not qualify if:

• 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%.
• 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.

Sponsors & Collaborators

• EirGenix, Inc.: lead

Study Sites (91)

Detroit Clinical Research Center

Farmington Hills, Michigan, 48334, United States

Location

Aultman Hospital, Cancer Center

Canton, Ohio, 44718, United States

Location

Brest Regional Oncology Center

Brest, Belarus

Location

Gomel Regional Clinical Oncology Center

Homyel, Belarus

Location

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

Lesnoy, Belarus

Location

Minsk City Clinical Oncology Center

Minsk, Belarus

Location

Mogilev Regional Oncology Center

Mogilev, Belarus

Location

Vitebsk Regional Clinical Oncology Center

Vitebsk, Belarus

Location

Medical Research Limited Society

Temuco, Chile

Location

Oncocentro Apys

Viña del Mar, Chile

Location

Clinic Life Foundation

Medellín, Colombia

Location

Rodrigo Botero SAS

Medellín, Colombia

Location

LTD High-Tech Hospital MedCenter

Batumi, Georgia

Location

JSC "Evex Hospitals

Kutaisi, Georgia

Location

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

Tbilisi, Georgia

Location

LTD Aversi Clinic

Tbilisi, Georgia

Location

LTD Cancer Research Centre

Tbilisi, Georgia

Location

LTD Health House

Tbilisi, Georgia

Location

LTD Institute of Clinical Oncology

Tbilisi, Georgia

Location

LTD S.Khechinashvili University Hospital

Tbilisi, Georgia

Location

Malkhaz Katsiashvili Multiprofile Emergency Medicine Center

Tbilisi, Georgia

Location

Cytecare Cancer Hospitals

Bengaluru, India

Location

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

Lucknow, India

Location

Tata Memorial Centre

Mumbai, India

Location

HCG NCHRI Cancer Centre

Nagpur, India

Location

Christian Medical College, Department of Medical Oncology

Vellore, India

Location

Arkhangelsk Clinical Oncology Center

Arkhangelsk, Russia

Location

Chelyabinsk Regional Clinical Oncology and Nuclear Medicine Center

Chelyabinsk, Russia

Location

Evimed, LLC

Chelyabinsk, Russia

Location

Ivanovo Regional Oncology Center

Ivanovo, Russia

Location

Republican Clinical Oncology Center

Kazan', Russia

Location

Krasnoyarsk A.I. Kryzhanovsky Regional Oncology Center

Krasnoyarsk, Russia

Location

Kursk Regional Clinical Oncology Center

Kursk, Russia

Location

N.N. Blokhin National Medical Oncology Research Center

Moscow, Russia

Location

National Medical Research Center for Radiology

Moscow, Russia

Location

Vitamed" LLC

Moscow, Russia

Location

A.F.Tsyb Medical Radiology Research Center

Obninsk, Russia

Location

Clinical Oncology Center

Omsk, Russia

Location

Pyatigorsk Interdistrict Oncology Center

Pyatigorsk, Russia

Location

Rostov Oncology Research Institute

Rostov-on-Don, Russia

Location

Regional Clinical Oncology Center

Ryazan, Russia

Location

AV Medical Group

Saint Petersburg, Russia

Location

City Clinical Oncology Center

Saint Petersburg, Russia

Location

Clinic "Mart"

Saint Petersburg, Russia

Location

I.I. Mechnikov North-Western State Medical University

Saint Petersburg, Russia

Location

Leningrad Regional Oncology Center (Outpatient Department)

Saint Petersburg, Russia

Location

Leningrad Regional Oncology Center (Surgery Department)

Saint Petersburg, Russia

Location

N.N. Petrov National Medical Research Center of Oncology

Saint Petersburg, Russia

Location

Oncology Center of Moskovskiy District

Saint Petersburg, Russia

Location

Private Medical Institution "EVROMEDSERVIS", Department of Oncology

Saint Petersburg, Russia

Location

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

Saint Petersburg, Russia

Location

Republican Oncology Center

Saransk, Russia

Location

Oncology Center #2

Sochi, Russia

Location

Tomsk National Research Medical Center

Tomsk, Russia

Location

Regional Clinical Oncology Center

Veliky Novgorod, Russia

Location

Volgograd Regional Clinical Oncology Center

Volgograd, Russia

Location

GVI Oncology, Cape Gate Oncology Centre

Cape Town, South Africa

Location

The Oncology Centre

Durban, South Africa

Location

Medical Oncology Centre of Rosebank

Johannesburg, South Africa

Location

Little Company of Mary Medical Center, Department of Oncology

Pretoria, South Africa

Location

University of Pretoria, Department of Medical Oncology

Pretoria, South Africa

Location

Keimyung University - Dongsan Medical Center

Daegu, South Korea

Location

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Location

China Medical University Hospital

Taichung, Taiwan

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

Taipei Veterans General Hospital

Taipei, Taiwan

Location

Tri-Service General Hospital

Taipei, Taiwan

Location

Linkou Chang Gung Memorial Hospital

Taoyuan District, Taiwan

Location

Chernihiv Regional Oncology Center

Chernihiv, Ukraine

Location

Chernivtsi Regional Clinical Oncology Center

Chernivtsi, Ukraine

Location

Clinical Oncology Center

Dnipro, Ukraine

Location

Dnipropetrovsk City Multispecialty Clinical Hospital #4, Department of Chemotherapy

Dnipro, Ukraine

Location

Prikarpattia Clinical Oncology Center

Ivano-Frankivsk, Ukraine

Location

Communal Non-profit enterprise "Regional Center of Oncology"

Kharkiv, Ukraine

Location

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

Kharkiv, Ukraine

Location

Khmelnytskyi Regional Oncology Center

Khmelnytskyi, Ukraine

Location

Kryvyi Rih Oncology Center, Department of Chemotherapy

Kryvyi Rih, Ukraine

Location

Kyiv City clinical Hospital #2

Kyiv, Ukraine

Location

Kyiv Regional Oncology Center, Department of Mastology

Kyiv, Ukraine

Location

Medical Center "Verum"

Kyiv, Ukraine

Location

Medical Center of First Private Clinic

Kyiv, Ukraine

Location

Volyn Regional Oncology Center, Department of Chemotherapy

Lutsk, Ukraine

Location

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

Lviv, Ukraine

Location

Mariupol Oncology Center

Mariupol, Ukraine

Location

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

Odesa, Ukraine

Location

Odesa Regional Oncology Center

Odesa, Ukraine

Location

Ternopil Regional Clinical Oncology Center, Department of Chemotherapy

Ternopil, Ukraine

Location

Central City Clinical Hospital, Department of Oncology and Radiology

Uzhhorod, Ukraine

Location

Zakarpattia Regional Clinical Oncology Center, Department of Chemotherapy

Uzhhorod, Ukraine

Location

Podillia Regional Oncology Center

Vinnytsia, Ukraine

Location

Zhytomyr Regional Oncology Center

Zhytomyr, Ukraine

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Trastuzumab

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

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: February 8, 2018
• First Posted: February 14, 2018
• Study Start: October 16, 2018
• Primary Completion: January 20, 2022
• Study Completion: January 20, 2022
• Last Updated: January 20, 2023

Record last verified: 2023-01

Locations

US (2); CL (2); KR (1); RU (30); GE (9); UA (23); IN (5); CO (2); ZA (5); TW (6); BE (6)