EMERALD Trial: Trastuzumab, Pertuzumab Plus Eribulin Effective in HER2-Positive Breast Cancer

When used in combination with trastuzumab and pertuzumab, eribulin is noninferior to trastuzumab and pertuzumab plus taxane in treating human epidermal growth factor 2 (HER2)-positive breast cancer, according to findings from the EMERALD study presented at the 2024 American Society of Clinical Oncology Annual Meeting.

“[Trastuzumab plus pertuzumab plus] taxane is a current standard first-line therapy for recurrent or metastatic [HER2-positive] breast cancer. However, taxane-induced toxicities, which reduce patient quality of life (QOL), necessitate the development of less toxic but at least equally effective taxane alternatives,” the researchers said.

In this multicenter, randomized, open-label, parallel-group, phase 3 trial, researchers analyzed 446 patients (median age, 56 years) between August 2017 and June 2021 to assess the noninferiority of eribulin plus trastuzumab and pertuzumab (intervention) against docetaxel/paclitaxel plus trastuzumab and pertuzumab (control) as first-line chemotherapeutic treatment in patients with locally advanced or metastatic HER2-positive breast cancer. Patients in the population of interest were randomized (1:1) to receive, by intravenous infusion in a 21-day cycle, either eribulin on days 1 and 8 or a taxane (docetaxel 75 mg/m² on day 1 or paclitaxel 80 mg/m² on days 1, 8, and 15), each being administered in combination with trastuzumab and pertuzumab on day 1. The primary outcome of interest was progression-free survival (PFS). Secondary end points included objective response rate, overall survival, QOL, and safety.

According to the results, the median PFS was 14.0 months in the intervention group and 12.9 months in the control group (hazard ratio, 0.96; 95% CI, 0.77-1.20), confirming noninferiority of the study regimen. Moreover, adverse drug reactions, including grade ≥3 febrile neutropenia, edema, and diarrhea were numerically lower in the intervention group than in the control group (4.9% vs 8.7%, 8.5% vs 42.2%, and 36.6% vs 54.1%, respectively).

“This is the first study to show noninferiority of eribulin to taxane when used in combination with dual HER2 blockade. As a less toxic but equally effective alternative to the taxane-containing regimen, eribulin combined with [trastuzumab and pertuzumab] could be first-line treatment of locally advanced or metastatic [HER2-positive breast cancer],” the researchers concluded.