Efficacy and Safety Study of EG12014 Compared With Herceptin in Subjects With HER2 Positive Early Breast Cancer
Completed · Phase 3
Conditions studied: Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT03433313
- Run by
- EirGenix, Inc.
- People needed
- 807
- Starts
- 2018-10-16
- Expected to finish
- 2022-01-20
- Last updated by the study team
- 2023-01-20
Who can join
Age: 18 and older, up to 65. Sex: female. Healthy volunteers: not accepted.
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.
Where it is running
- Aultman Hospital, Cancer Center — Canton, Ohio, United States
- Brest Regional Oncology Center — Brest, Belarus
- Gomel Regional Clinical Oncology Center — Homyel, 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, Belarus
- Medical Research Limited Society — Temuco, Chile
- Oncocentro Apys — Viña del Mar, Chile
- Clinic Life Foundation — Medellín, Colombia
- Rodrigo Botero SAS — Medellín, Colombia
- 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, Georgia
- 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
- Detroit Clinical Research Center — Farmington Hills, Michigan, United States
Full record on ClinicalTrials.gov
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