NCT05530057

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

HER2-targeted therapy is the mainstay therapeutic option for the treatment of HER2 positive breast cancer patients. Even after progression on HER2-targeted therapy, HER2 remains an effective therapeutic target. In a phase III randomized clinical trial, Lapatinib plus capecitabine showed superior outcome compared to capecitabine alone in HER2 positive breast cancer patients who has progressed after trastuzumab-based therapy Moreover, ado-trastuzumab emtansine (T-DM1) showed improved progression free survival (PFS) and overall survival (OS) in HER2-positive advanced breast cancer patients previously treated with trastuzumab and a taxane. Not only switching to a different HER2-targeted agent, but rechallenge of trastuzumab has also shown efficacy in trastuzumab failed HER2-positive breast cancer patients. In HER2-positive breast cancer patients who failed trastuzumab and lapatinib, rechallenge of trastuzumab in combination with conventional chemotherapy showed response rate of 31%, PFS of 4.9 months, and OS of 19.4 months. Eribulin mesylate is a non-taxane inhibitor of microtubule which shows efficacy in HER2-positive breast cancer. The efficacy of eribulin and trastuzumab combination chemotherapy as first line palliative chemotherapy in HER2-positive breast cancer was identified in a phase II trial. Eribulin plus trastuzumab was an effective regimen which showed response rate of 71.2% and PFS of 11.6 months. Currently, the first line regimen for HER2-positive metastatic breast cancer is combination therapy of pertuzumab, trastuzumab, and docetaxel as a result of the CELOPARTRA trial . After failure on pertuzumab and trastuzumab based combination chemotherapy, T-DM1 is frequently used as a 2nd line therapy. 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.

Conditions

• Advanced Breast Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-02-18
• Primary completion: 2028-06-30
• Completion: 2028-06-30
• First posted: 2022-09-07
• Last updated: 2025-11-20

Locations

1 site across 1 country: South Korea