Efficacy and safety of eribulin mesylate vs. docetaxel or paclitaxel, combined with trastuzumab and pertuzumab, as first-line treatment for HER2-positive locally advanced or metastatic breast cancer: updated subgroup analyses of JBCRG-M06/EMERALD.

Norikazu Masuda, Shigehira Saji, Yasuyuki Kojima, Masahiro Kitada, Hiroshi Tada, Tsutomu Iwasa, Kei Koizumi, Tsuguo Iwatani, Yasuaki Sagara, Takashi Kuwayama, Masafumi Shimoda, Tatsunari Sasada, Koichiro Tsugawa, Yoshihiro Kawaguchi, Akihiko Shimomura, Takuhiro Yamaguchi, Hiroki Hasegawa, Shun Osaka, Satoshi Morita, Toshinari Yamashita

Journal: Breast cancer research and treatment 2026;218(1):

PMID: 42420599

Full Text on Springer View on PubMed

Abstract

PURPOSE

We performed updated subgroup analyses of the EMERALD study to investigate efficacy, safety, and quality of life (QoL) in patients treated with eribulin (E) vs. either docetaxel (DTX) or paclitaxel (PTX).

METHODS

Patients with HER2+ locally advanced/metastatic breast cancer (LABC/MBC) were randomized to receive E or taxane (T) (physician's choice of DTX or PTX; declared in advance at registration) in 21-day cycles, each combined with trastuzumab + pertuzumab. Survival outcomes, treatment patterns, antitumor efficacy, safety, and QoL were examined.

RESULTS

The intention-to-treat (and safety) populations comprised 224 (224) patients who received E, 186 (184) who received DTX, and 36 (34) who received PTX. Baseline characteristics were balanced. Progression-free survival (E vs. DTX: 14.0 vs. 13.1 months; hazard ratio [HR], 0.94 [95% CI, 0.74-1.21]; E vs. PTX: 14.1 vs. 10.8 months; HR, 1.00 [95% CI, 0.58-1.73]) and overall survival (E vs. DTX: not reached [NR] vs. NR; E vs. PTX: 75.5 months vs. NR) were similar among the subgroups. Although the incidences of adverse events (AEs) were generally similar, peripheral sensory neuropathy was more frequent with PTX and less frequent with DTX, compared with E. Neutropenia tended to be more frequent with E. Median time to QoL deterioration was longer with E vs. DTX (7.8 vs. 4.7 months) and E vs. PTX (6.1 vs. 3.9 months).

CONCLUSIONS

This trial revealed comparable efficacy of E vs. either DTX or PTX, when combined with dual HER2 blockade as first-line treatment for HER2+ LABC/MBC. AEs were generally similar between the E and T subgroups. QoL was maintained for longer in the E subgroups vs. T subgroups.

TRIAL REGISTRATION

ClinicalTrials.gov (NCT03264547; registered: 28 June 2017); University Hospital Medical Information Network (UMIN000027938; registered: 26 June 2017).

Address: Department of Breast Surgery, Graduate School of Medicine, Kyoto University, 54 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto, 606-8507, Japan. [email protected].; Department of Medical Oncology, Fukushima Medical University, Fukushima, Japan.; Institute for Clinical Genetics and Genomics / Division of Breast Surgical Oncology, Department of Surgery, Showa Medical University, Tokyo, Japan.; Department of Breast Disease Center, Asahikawa Medical University Hospital, Hokkaido, Japan.; Department of Surgery, Division of Breast and Endocrine Surgery, Tohoku University Graduate School of Medicine, Miyagi, Japan.; Division of Breast and Endocrine Surgery, Tohoku Medical and Pharmaceutical University, Miyagi, Japan.; Department of Medical Oncology, Kindai University Hospital, Osaka, Japan.; Department of Surgery 1, Division of Breast Surgery, Hamamatsu University School of Medicine, Shizuoka, Japan.; Department of Breast and Endocrine Surgery, St. Marianna University School of Medicine, Kanagawa, Japan.; Department of Breast and Thyroid Surgical Oncology, Social Medical Corporation Hakuaikai, Sagara Hospital, Kagoshima, Japan.; Department of Breast Surgery, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan.; Department of Breast and Endocrine Surgery, Hyogo Medical University Hospital, Hyogo, Japan.; Department of Breast and Endocrine Surgery, NHO Higashihiroshima Medical Center, Hiroshima, Japan.; Department of Breast Surgery, Asahi University Hospital, Gifu, Japan.; Department of Breast and Medical Oncology, National Center for Global Health and Medicine, Tokyo, Japan.; Division of Biostatistics, Tohoku University Graduate School of Medicine, Miyagi, Japan.; Medical HQs, Eisai Co., Ltd, Tokyo, Japan.; Department of Biomedical Statistics and Bioinformatics, Graduate School of Medicine, Kyoto University, Kyoto, Japan.; Department of Breast Surgery and Oncology, Kanagawa Cancer Center, Kanagawa, Japan.

DOI: 10.1007/s10549-026-08004-5

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https://doi.org/10.1007/s10549-026-08004-5

MeSH Terms: Humans, Polyether Polyketides, Female, Ketones, Breast Neoplasms, Furans, Antineoplastic Combined Chemotherapy Protocols, Erb-b2 Receptor Tyrosine Kinases, Trastuzumab, Antibodies, Monoclonal, Humanized, Paclitaxel, Docetaxel, Quality of Life, Middle Aged, Aged, Adult, Treatment Outcome, Neoplasm Metastasis