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Clinical Trials List

Protocol NumberEGC102
Not yet recruiting

2025-06-01 - 2028-05-31

Phase III

Recruiting11

ICD-10C50.011

Malignant neoplasm of nipple and areola, right female breast

ICD-10C50.012

Malignant neoplasm of nipple and areola, left female breast

ICD-10C50.019

Malignant neoplasm of nipple and areola, unspecified female breast

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9174.0

Malignant neoplasm of female breast, nipple and areola

A Phase 3, Randomized, Multicenter, Parallel-arm, Double-blind Study to Compare Efficacy and Safety of EG1206A (EirGenix’ Pertuzumab) and Perjeta® (Pertuzumab) Sourced from EU as Neoadjuvant Treatment in Combination with Trastuzumab and Chemotherapy in Patients with HER2-positive Hormone Receptor-negative Early Breast Cancer

  • Sponsor

    EirGenix, Inc.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Kuo-Ting Lee Division of General Surgery
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

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 馮盈勳 Division of Hematology & Oncology
Chi Mei Medical Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator CHIN-SHENG HUNG Division of General Surgery
Taipei 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 Recruiting

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

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 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 陳守棟 Division of General Surgery
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Ming-Feng Hou Division of General Surgery
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator TSU-YI CHAO
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

HER2-positive Hormone Receptor-negative Early Breast Cancer

Objectives

The primary objective of this study is to demonstrate therapeutic equivalence of EG1206A and Perjeta, both given in combination with trastuzumab and chemotherapy as part of neoadjuvant therapy in patients with human epidermal growth factor receptor 2 (HER2)-positive EBC in terms of efficacy determined by pCR, defined as ypT0/is ypN0 at the time of surgery, assessed by central laboratory.

Test Drug

injection

Active Ingredient

Pertuzumab

Dosage Form

27D

Dosage

420mg/14ml

Endpoints

pCR at time of surgery, where pCR is defined as the absence of residual invasive cancer of the complete resected breast specimen (regardless of DCIS) and all sampled sentinel and/or axillary lymph nodes (ypT0/is ypN0), as assessed by central laboratory.

Inclution Criteria

1. Provide signed and dated written informed consent before any study-related procedures are performed. The informed consent will cover both parts of the study (neoadjuvant part and adjuvant part).
2. Female and male patients ≥ 18 and ≤ 70 years of age.
3. Histologically-confirmed invasive carcinoma of the breast.
4. Early stage (T2–3, N0–1, M0), locally advanced stage (T2–3, N2–3, M0 or T4a–c, any N, M0), or inflammatory (T4d, any N, M0) breast cancer planned for surgical resection (mastectomy or lumpectomy of the breast, and resection of 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 status (according to American Society of Clinical Oncology/College of American Pathologists [ASCO/CAP] guidelines [2018, 2023]), as confirmed by central laboratory [41, 42].
7. Estrogen receptor and progesterone receptor-negative tumor (according to ASCO/CAP guidelines [2020]), as confirmed by central laboratory [43].
8. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.
9. Baseline LVEF ≥ 55%, measured by echocardiography or MUGA.
10. Adequate bone marrow function, defined as neutrophil count of ≥ 1,500/μL, hemoglobin ≥ 9 g/dL, and platelet count of ≥ 100,000/μL.
11. Adequate hepatic and renal function, defined as total bilirubin ≤ 1.5 × upper limit of normal (ULN) (or ≤ 3 × ULN and direct bilirubin within normal limits in patients with well documented Gilbert’s syndrome), alanine aminotransferase (ALT) ≤ 3 × ULN, aspartate aminotransferase (AST) ≤ 3 × ULN, creatinine clearance ≥ 30 mL/min (according to Cockcroft and Gault equation).
12. International normalized ratio ≤ 1.5 × ULN (2 to 3 × ULN if on anticoagulants with vitamin K antagonists) or prothrombin time ≤ 1.5 × ULN; activated partial thromboplastin time ≤ 1.5 × ULN.
13. For women of childbearing potential (WOCBP):
WOCBP must have a negative serum pregnancy test at Screening and must use 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 the End of Treatment (EOT) Visit. 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. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause.
14. For men:
Men must agree to use reliable contraceptive measures throughout the duration of the study and for 7 months after the EOT Visit. These methods include documented vasectomy, double-barrier contraception (i.e., condom and diaphragm), or true sexual abstinence (when this is in line with the preferred and usual lifestyle of the patient).
15. Patients with complete pathological remission.
16. Patients with residual disease that cannot receive further treatment with trastuzumab emtansine (in case of contraindication to trastuzumab emtansine, recommendations from local guidelines, or at the discretion of the Investigator).

Exclusion Criteria

1. Stage IV (metastatic) breast cancer, bilateral breast cancer.
2. Pregnancy or lactation or considering becoming pregnant.
3. 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.
4. Previous treatment with Perjeta.
5. Active hepatitis B or hepatitis C infection, or infection with the human immunodeficiency virus (HIV) as shown by a positive diagnostic test for hepatitis B virus (HBV), hepatitis C virus (HCV) or HIV.
6. History of or existing CHF New York Heart Association class II or higher; angina pectoris or arrhythmia requiring medication; poorly controlled hypertension; history of myocardial infarction or cardiac failure; clinically significant cardiac valvular disease; hemodynamic effective pericardial effusion; other cardiomyopathies.
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 IMP (EG1206A or Perjeta), whichever is longer.
8. Hypersensitivity to the IMP (EG1206A or Perjeta), trastuzumab or trastuzumab biosimilar, carboplatin (or other platin compounds), and docetaxel, or to any of their excipients.
9. Vaccination with live attenuated vaccines during the study.
10. History of, or known current problems with, drug or alcohol abuse.
11. Other serious illness, previous surgery (other than for invasive malignant disease), 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

    67 participants

  • Global

    380 participants

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