Status and phase
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About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
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).
Female, ≥18 and ≤65 years of age.
Histologically-confirmed invasive carcinoma of the breast (American Joint Committee on Cancer [AJCC, vs. 8.0] Stage II, IIIa).
Operable breast cancer, planned surgical resection of breast tumor (mastectomy or lumpectomy) and sentinel or axillary lymph nodes.
Unilateral, measurable tumor of the breast >2 cm in diameter.
HER2 positive tumor, defined as 3+ score by IHC or fluorescence positive by FISH, as confirmed by central laboratory.
Known estrogen receptor (ER) and progesterone receptor (PrR) status at study entry.
Adequate bone marrow function, defined as granulocyte count of ≥1.500/µL, and platelet count of ≥100.000/µL.
Adequate hepatic and renal function, defined as:
bilirubin within normal range
alanine aminotransferase (ALT) ≤2 x upper limit of normal (ULN)
aspartate aminotransferase (AST) ≤2 x ULN
gamma glutamyl transferase (GGT) ≤3 x ULN
serum creatinine <1.5 ULN
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.
Hemoglobin concentrations ≥10 g/dL.
Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.
LVEF ≥55%, measured by multiple-gated acquisition (MUGA) scan or echocardiography.
Negative pregnancy test at entry, women of childbearing potential have to use contraceptives during the course of the study.
Females with childbearing potential must provide a negative serum pregnancy test at Screening and must be using 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 study drug treatment. 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.
Exclusion Criteria:
Primary purpose
Allocation
Interventional model
Masking
807 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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