RecruitingPhase 2NCT05530057

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

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


Sponsor

Seoul National University Hospital

Enrollment

180 participants

Start Date

Feb 18, 2020

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing eribulin (a chemotherapy drug) with or without trastuzumab (a HER2-targeted antibody) in people with HER2-positive breast cancer that has returned or spread to other parts of the body, and who have already received prior HER2-targeted therapies. **You may be eligible if...** - You are 18 or older with unresectable or metastatic HER2-positive breast cancer - You have been previously treated with trastuzumab, T-DM1 or T-Dxd, and a taxane chemotherapy - You have had fewer than 4 prior lines of chemotherapy or HER2-targeted therapy for metastatic disease - Your disease has shown clear progression on imaging - You are in good functional health (ECOG 0–1) with adequate blood, liver, and kidney function **You may NOT be eligible if...** - You have not previously received the required prior therapies - You have received 4 or more prior lines of treatment in the metastatic setting - You are pregnant or breastfeeding - Your organ function is not adequate for chemotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEribulin 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.

DRUGEribulin 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

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NCT05530057


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