Randomized, Open Label, Multi-Center, Phase II Trial of Eribulin With or Without SB3 (Trastuzumab-biosimilar) in Patients With HER2-overexpressed Recurrent or Stage IV Breast Cancer Who Have Received at Least 2 Prior HER2-directed Regimens
Optimal salvage treatment for HER2-positive breast cancer after trastuzumab and T-DM1 failure still remains to be established. We would like to investigate the efficacy and safety of combination chemotherapy of eribulin and trastuzumab as salvage treatment for HER2-Positive breast cancer after exposure to trastuzumab and T-DM1
• Adults ≥18 years old.
• Pathologically documented breast cancer that:
‣ is unresectable or metastatic
⁃ has confirmed HER2 positive expression (immunohistochemistry or FISH) as determined according to American Society of Clinical Oncology - College of American Pathologists guidelines evaluated at a central laboratory
⁃ was previously treated with trastuzumab, T-DM1, and taxane (whether in recurrent/metastatic setting or neoadjuvant/adjuvant setting).
⁃ Less than 4 prior lines of chemotherapy or HER2 targeted therapies for treatment in metastatic disease (\<4 treatment regimens for recurrent/metastatic disease excluding adjuvant treatments)
• Documented radiologic progression (during or after most recent treatment or within 6 months after completing adjuvant therapy).
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, or 1
• Male and female subjects of reproductive/childbearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and for at least 4.5 months after the last dose of study treatment.
• Adequate hematopoietic, renal and hepatic functions.
• Adequate hematopoietic function: Absolute granulocyte count ≥1,500/mm3, platelet≥100,000/mm3, hemoglobin≥10g/mm3
• Adequate hepatic function: total bilirubin ≤1.5mg/dL, AST/ALT ≤2 x UNL, alkaline phosphatase ≤2.5 x UNL, in case with bone metastases alkaline phosphatase ≤5 x UNL
• Adequate renal function: Serum creatinine ≤1.5mg/dL
• a left ventricular ejection fraction of 50% or more (determined by echocardiography or multiple-gated acquisition \[MUGA(Multigated Blood Pool Scan)\] scanning)
• CNS(central nervous system) metastasis is permitted if asymptomatic or controlled with minimal steroid requirement and is documented to be non-progressing at study entry.
• Negative urine pregnancy test within 7 days prior to registration in premenopausal patients
• Ability to understand and comply with protocol during study period
• Patients should sign a written informed consent before study entry