The study of Eribulin and Trastuzumab-biosimilar in patients with HER2-overexpressed recurrent or stage IV breast cancer

Seoul National University Hospital is starting a new clinical trial of Eribulin With or Without Trastuzumab-biosimilar in Patients With HER2-overexpressed Recurrent or Stage IV Breast Cancer.

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

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 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.

The clinical trial started in February 18, 2020 and will continue throughout December 31, 2025.

The inclusion parameter is Adults ≥18 years old. - Pathologically documented breast cancer that: - is unresectable or metastatic - has confirmed HER2 positive expression (immunohistochemistry or FISH) as determined according to American Society of Clinical Oncology - College of American Pathologists guidelines evaluated at a central laboratory - was previously treated with trastuzumab, T-DM1, and taxane (whether in recurrent/metastatic setting or neoadjuvant/adjuvant setting). - Less than 4 prior lines of chemotherapy or HER2 targeted therapies for treatment in metastatic disease (<4 treatment regimens for recurrent/metastatic disease excluding adjuvant treatments) - Documented radiologic progression (during or after most recent treatment or within 6 months after completing adjuvant therapy), for complete list and more details see: https://ichgcp.net/clinical-trials-registry/NCT05530057.

The location is the Seoul National University Hospital, Seoul, Korea, Republic of.