Eribulin With or Without Trastuzumab-biosimilar in Patients With HER2-overexpressed Recurrent or Stage IV Breast Cancer

PHASE2RecruitingINTERVENTIONAL
Enrollment

180

Participants

Timeline

Start Date

February 18, 2020

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2026

Conditions
Advanced Breast Cancer
Interventions
DRUG

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."

DRUG

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."

Trial Locations (1)

Unknown

RECRUITING

Seoul National University Hospital, Seoul

All Listed Sponsors
lead

Seoul National University Hospital

OTHER

NCT05530057 - Eribulin With or Without Trastuzumab-biosimilar in Patients With HER2-overexpressed Recurrent or Stage IV Breast Cancer | Biotech Hunter | Biotech Hunter