問卷
Log In
繁中 EN
TPIDB
TPIDB Outstanding PI
TPIDB > Search Result > Clinical Trials List

Clinical Trials List

Protocol NumberEGC002
NCT Number(ClinicalTrials.gov Identfier)NCT03433313
Completed

2018-05-02 - 2022-01-20

Phase III

Recruiting3

Terminated4

ICD-10C50

Malignant neoplasm of breast

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

  • Trial Applicant

    TAIWAN PSI HEALTH DEVELOPMENT COMPANY LIMITED

  • Sponsor

    EirGenix Inc.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/03/01

Investigators and Locations

Principal Investigator Ling-Ming Tseng Division of General Surgery
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Audit

None

Principal Investigator 戴明燊 Division of Hematology & Oncology
Tri-Service General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Liang-Chih Liu Division of General Surgery
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chiun-Sheng Huang Division of General Surgery
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator Shin-Cheh Chen Division of General Surgery
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator 巫承哲 Division of General Surgery
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator 陳守棟 Division of General Surgery
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Condition/Disease

HER2-Positive Early Breast Cancer

Objectives

Primary Objective  The primary objective of this study is to demonstrate therapeutic equivalence of EG12014 and Herceptin, both given in combination with paclitaxel for 12 weeks (4 cycles) as part of neoadjuvant therapy in patients with HER2-positive EBC, in terms of efficacy determined by pCR (ypT0/is ypN0) at the time of surgery, assessed by central laboratory. Secondary Objectives The secondary objectives are:  Further evaluation of pCR at surgery (ypT0 ypN0, and ypT0/is).  Evaluation of EFS.  Evaluation of overall response (OR) prior to surgery according to RECIST v1.1 criteria.  Evaluation of OS.  Comparison of the safety profile of EG12014 and Herceptin during neoadjuvant treatment, and the safety of EG12014 and Herceptin during the entire study.  Evaluation of the immunogenicity of EG12014 and Herceptin.  Comparison of EG12014 and Herceptin pharmacokinetics (PK) in the neoadjuvant setting.

Test Drug

EG12014

Active Ingredient

Trastuzumab

Dosage Form

Powder for Solution

Dosage

150

Endpoints

Primary Endpoint
 pCR at time of surgery, where pCR is defined as the absence of residual invasive
cancer on hematoxylin and eosin evaluation of the complete resected breast specimen
(regardless of ductal carcinoma in situ [DCIS]), and all sampled sentinel and/or
axillary lymph nodes (ypT0/is ypN0), as assessed by central laboratory.

Secondary Endpoints
 Efficacy:
- pCR at the time of surgery, where pCR is defined as the absence of residual
invasive cancer and of DCIS (ypT0 ypN0) from breast tissue and sentinel/axillary
lymph nodes, as assessed by central laboratory.
- pCR at the time of surgery, defined as the absence of invasive cancer in breast
tissue only (ypT0/is), as assessed by central laboratory.
- EFS up to end of study (EOS), 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.
- Objective response prior to surgery, defined as PR or CR according to
RECIST v1.1.
- OS up to EOS, defined as time from the date of initial randomization to the date
of death.
 Safety:
- Incidence of AEs (including severity, seriousness, and relationship to study drug)
and laboratory abnormalities.
- Cardiac safety.
 Immunogenicity: Incidence and titer of ADA.
 Serum trastuzumab concentration and/or population PK.

Inclution Criteria

Patients will be entered into this study only if they meet all of the following criteria:
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 [42]).
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 (by ultrasound and/or
mammography).
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 neutrophil count of ≥1.500/μL and platelet count of ≥ 100.000/μL.
9. Adequate hepatic and renal function, defined as:
bilirubin ≤ 2 x upper limit of normal (ULN)
alanine aminotransferase (ALT) ≤ 2 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.

Inclusion Criterion after Surgery (Adjuvant Part of the Study)
After completion of the neoadjuvant part of the study and surgery, patients will be
eligible for double-blind adjuvant therapy with EG12014 or Herceptin if they meet the following criterion:
1. No sequelae have occurred after neoadjuvant therapy, in particular regarding cardiac function. No separate informed consent is required.

Exclusion Criteria

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.

The Estimated Number of Participants

  • Taiwan

    50 participants

  • Global

    800 participants

聯絡我們

台灣臨床試驗主持人資料庫 TPIDB

All Contents Copyright 2020 台灣臨床試驗主持人資料庫TPIDB