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RECRUITING
NCT05530057
PHASE2

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

Sponsor: Seoul National University Hospital

View on ClinicalTrials.gov

Summary

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

Official title: 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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

180

Start Date

2020-02-18

Completion Date

2028-06-30

Last Updated

2025-11-20

Healthy Volunteers

No

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.

Locations (1)

Seoul National University Hospital

Seoul, South Korea