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Peer-reviewedCC BY 4.0Frontiers in Immunology

Eribulin mesylate in combination with ivonescimab as first-line treatment for unresectable locally advanced or metastatic triple-negative breast cancer(EMIT): study protocol for a single-arm, multicenter clinical trial

  • Haiqi Lu1
  • Xufei Wang2
  • Zhuo Wang1
  • Miaoqin Chen1
  • Yiming Zhong1
  • Lingfeng Ma3
  • Wanfen Tang4
  • Xian Wang1
  • Guangliang Li5
5 affiliations
  1. 1Department of Medical Oncology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
  2. 2Nursing Department, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
  3. 3Laboratory of Cancer Biology, Key Lab of Biotherapy in Zhejiang Province, Cancer Center of Zhejiang University, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
  4. 4Department of Medical Oncology, Jinhua Central Hospital/Affiliated Jinhua Hospital, Zhejiang University School of Medicine
  5. 5Department of Breast Medical Oncology, Zhejiang Cancer Hospital, Hangzhou Institute of Medicine (HIM), Chinese Academy of Sciences
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Abstract

Background: Advanced triple-negative breast cancer (TNBC) has an extremely poor prognosis, and current therapies offer limited benefits for patients with low programmed cell death ligand 1(PD-L1) expression. This study innovatively proposes a “novel chemotherapy + bispecific antibody” model. Eribulin Mesylate (hereinafter referred to as Eribulin), a novel microtubule inhibitor, kills tumor cells while remodeling the tumor microenvironment. When combined with the PD-1/VEGF bispecific antibody Ivonescimab, it concurrently dismantles immunosuppression and angiogenesis to synergistically overcome immunotherapy resistance.

Methods: This is a multicenter, open-label, single-arm clinical trial designed to enroll 29 patients with locally advanced or metastatic TNBC who have not received prior systemic anticancer therapy, and who are either ineligible for radical surgical resection or local therapy, or have experienced disease progression following postoperative adjuvant therapy. The primary endpoint is the objective response rate (ORR) assessed by Investigator Assessment (INV) at each participating center based on strict adherence to Response Evaluation Criteria in Solid Tumors version 1.1(RECIST v1.1) criteria. Secondary endpoints include progression-free survival (PFS), overall survival (OS), duration of response (DoR), and safety. Exploratory endpoints involve potential biomarkers, the correlation between PD-L1 expression and efficacy, and patient-reported outcomes (PROs).

Discussion: This combination regimen is expected to leverage the synergistic advantages of “chemotherapy-promoted immunity and potent bispecific antibody efficacy,” providing novel evidence-based medical evidence for the first-line treatment of metastatic TNBC and thereby effectively addressing significant unmet clinical needs.

Clinical Trial Registration: http://www.chictr.org.cn/ , identifier ChiCTR2600117652.

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Cite

BibTeXRIS
BibTeX
@article{lu2026eribulin,
  title = {{Eribulin mesylate in combination with ivonescimab as first-line treatment for unresectable locally advanced or metastatic triple-negative breast cancer(EMIT): study protocol for a single-arm, multicenter clinical trial}},
  author = {Haiqi Lu and Xufei Wang and Zhuo Wang and Miaoqin Chen and Yiming Zhong and Lingfeng Ma and Wanfen Tang and Xian Wang and Guangliang Li},
  journal = {Frontiers in Immunology},
  year = {2026},
  month = oct,
  doi = {10.3389/fimmu.2026.1927990},
  url = {https://www.frontiersin.org/articles/10.3389/fimmu.2026.1927990/full},
  note = {CC BY 4.0},
}
RIS
TY  - JOUR
TI  - Eribulin mesylate in combination with ivonescimab as first-line treatment for unresectable locally advanced or metastatic triple-negative breast cancer(EMIT): study protocol for a single-arm, multicenter clinical trial
AU  - Haiqi Lu
AU  - Xufei Wang
AU  - Zhuo Wang
AU  - Miaoqin Chen
AU  - Yiming Zhong
AU  - Lingfeng Ma
AU  - Wanfen Tang
AU  - Xian Wang
AU  - Guangliang Li
PY  - 2026
DA  - 2026/10/21
JO  - Frontiers in Immunology
DO  - 10.3389/fimmu.2026.1927990
UR  - https://www.frontiersin.org/articles/10.3389/fimmu.2026.1927990/full
AB  - Background: Advanced triple-negative breast cancer (TNBC) has an extremely poor prognosis, and current therapies offer limited benefits for patients with low programmed cell death ligand 1(PD-L1) expression. This study innovatively proposes a “novel chemotherapy + bispecific antibody” model. Eribulin Mesylate (hereinafter referred to as Eribulin), a novel microtubule inhibitor, kills tumor cells while remodeling the tumor microenvironment. When combined with the PD-1/VEGF bispecific antibody Ivonescimab, it concurrently dismantles immunosuppression and angiogenesis to synergistically overcome immunotherapy resistance.  Methods: This is a multicenter, open-label, single-arm clinical trial designed to enroll 29 patients with locally advanced or metastatic TNBC who have not received prior systemic anticancer therapy, and who are either ineligible for radical surgical resection or local therapy, or have experienced disease progression following postoperative adjuvant therapy. The primary endpoint is the objective response rate (ORR) assessed by Investigator Assessment (INV) at each participating center based on strict adherence to Response Evaluation Criteria in Solid Tumors version 1.1(RECIST v1.1) criteria. Secondary endpoints include progression-free survival (PFS), overall survival (OS), duration of response (DoR), and safety. Exploratory endpoints involve potential biomarkers, the correlation between PD-L1 expression and efficacy, and patient-reported outcomes (PROs).  Discussion: This combination regimen is expected to leverage the synergistic advantages of “chemotherapy-promoted immunity and potent bispecific antibody efficacy,” providing novel evidence-based medical evidence for the first-line treatment of metastatic TNBC and thereby effectively addressing significant unmet clinical needs.  Clinical Trial Registration: http://www.chictr.org.cn/ , identifier ChiCTR2600117652.
SN  - 1664-3224
ER  -