180
Participants
Start Date
February 18, 2020
Primary Completion Date
December 31, 2026
Study Completion Date
December 31, 2026
Eribulin Mesylate + Samfenet (Trastruzumab-biosimilar)
"* Patients will receive eribulin mesylate 1.4 mg/m2 administered I.V. with infusion over 2 to 5 minutes on days 1 and 8 of each 21-day cycle and SB3 8 mg/kg I.V. over 90 minutes on day 1 of cycle 1 . Thereafter, SB3 6 mg/kg will be infused over 30 minutes on day 1 of each subsequent 21-day cycle until progression or unacceptable toxicity.~* Dose reductions for eribulin, but not for SB3, is permitted.~* Two dose reductions (1.1, 0.7 mg/m2) are allowed for eribulin before consideration of study treatment discontinuation. Eribulin could be continued as monotherapy if trastuzumab-similar was discontinued, and vice-versa."
Eribulin Mesylate
"* Patients will receive eribulin mesylate 1.4 mg/m2 administered I.V. with infusion over 2 to 5 minutes on days 1 and 8 of each 21-day cycle until progression or unacceptable toxicity.~* Two dose reductions (1.1, 0.7 mg/m2) are allowed before consideration of study treatment discontinuation."
RECRUITING
Seoul National University Hospital, Seoul
Seoul National University Hospital
OTHER