Efficacy and Safety Study of EG1206A (EirGenix' Pertuzumab) Compared With EU-sourced Perjeta® (Pe… (NCT06884254) | Clinical Trial Compass
WithdrawnPhase 3
Efficacy and Safety Study of EG1206A (EirGenix' Pertuzumab) Compared With EU-sourced Perjeta® (Pertuzumab) in Patients With HER2-positive Hormone Receptor Negative Early Breast Cancer.
Stopped: Following SA from both the US FDA and the EMA, EirGenix, Inc. has decided to streamline the clinical-development program for EG1206A (biosimilar to Perjeta). EirGenix has concluded that the continuation of the study in no longer necessary.
United States0Started 2025-05
Plain-language summary
The purpose of this research study is to compare the efficacy and safety of EG1206A with Perjeta in combination with trastuzumab and chemotherapy as neoadjuvant treatment for 18 weeks, followed by surgery and subsequent EG1206A or Perjeta in combination with trastuzumab, as adjuvant treatment for 36 weeks.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. 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).
✓. Female and male patients ≥ 18 and ≤ 70 years of age.
✓. Histologically-confirmed invasive carcinoma of the breast.
✓. 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).
✓. Unilateral, measurable tumor of the breast \> 2 cm in diameter (by ultrasound and/or mammography).
✓. 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.
✓. Estrogen receptor and progesterone receptor-negative tumor (according to ASCO/CAP guidelines \[2020\]), as confirmed by central laboratory.
✓. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.
Exclusion criteria
✕. Stage IV (metastatic) breast cancer, bilateral breast cancer.
✕. Pregnancy or lactation or considering becoming pregnant.
✕. 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.
What they're measuring
1
Determination of pathologic complete response (pCR) at time of surgery
Timeframe: At the time of surgery (3-6 weeks after completion of neoadjuvant chemotherapy)
✕. 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.
✕. History of or existing congestive heart failure (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.
✕. 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 (IMP: EG1206A or Perjeta), whichever is longer.
✕. Hypersensitivity to the IMP (EG1206A or Perjeta), trastuzumab or trastuzumab biosimilar, carboplatin (or other platin compounds), and docetaxel, or to any of their excipients.