Sintilimab plus eribulin and carboplatin in patients with metastatic triple-negative breast cancer (SECURE): a phase II, multicenter trial
4 affiliations
- 1Department of Medical Oncology, State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer Center, Guangzhou, China
- 2Cancer Hospital, Affiliated Hospital of Guangdong Medical University, Zhanjiang, China
- 3Department of Pathology, State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer Center, Guangzhou, China
- 4Department of Breast, Bone and Soft Tissue Oncology, Guangxi Medical University Cancer Hospital, Nanning, China
Abstract
Background: The clinical benefit of combining chemotherapy with immunotherapy in metastatic triple-negative breast cancer (TNBC) varies depending on the chemotherapy backbone, highlighting the need for optimizing combination partners. This single-arm exploratory phase II trial evaluated the efficacy and safety of sintilimab combined with eribulin and carboplatin (ErCb) in patients with metastatic TNBC previously treated with anthracyclines and/or taxanes.
Methods: Eligible patients received eribulin 1.4 mg/m2 and carboplatin (area under the curve=2) on days 1 and 8, plus sintilimab 200 mg on day 8 of each 21-day cycle. The primary endpoint was the objective response rate (ORR). Secondary endpoints included progression-free survival (PFS), overall survival (OS), disease control rate (DCR), and safety. The trial was registered in the Chinese Clinical Trial Registry (No. ChiCTR2400082647).
Results: Between February 2024 and March 2025, 27 female patients were enrolled. All patients had received prior treatment with anthracyclines and/or taxane-based chemotherapy. 18 patients (66.7%) had ≥3 metastatic lesions, 19 (70.4%) had visceral metastases, and 5 (18.5%) had brain metastases (BM). The confirmed ORR was 70.4% and DCR was 81.5%. At a median follow-up of 16.2 months, median PFS was 7.6 months; median OS was immature at 19.0 months, with only 33.3% of events reported. Notably, all five patients with BM achieved a partial response in both intracranial and systemic lesions. In an exploratory multivariate analysis, Eastern Cooperative Oncology Group performance status 1, ≥3 metastatic sites, and programmed cell death-ligand 1 negativity were potentially associated with worse PFS. The most common grade ≥3 adverse events (AEs) were neutropenia (48.1%), febrile neutropenia (14.8%), and thrombocytopenia (7.4%), stomatitis (3.7%), and aspartate aminotransferase/aspartate aminotransferase elevation (3.7%). Hypothyroidism (18.5%) was the most common immunotherapy-related adverse event (irAE), with no grade ≥3 irAEs observed. Exploratory biomarker analyses suggested that higher baseline CXCL10, CCL28, CD58, and CD99 levels were associated with longer survival, whereas insulin-like growth factor-binding trended downward at progression. RNA-sequencing data revealed enrichment of the hypoxia-inducible factor 1 (HIF-1) pathway in poor responders and at progression.
Conclusion: In this exploratory phase II trial, sintilimab plus ErCb showed promising preliminary antitumor activity and a manageable safety profile in patients with anthracycline-pretreated and/or taxane-pretreated metastatic TNBC. These hypothesis-generating findings support further evaluation in larger, randomized controlled trials.
Trial registration number: ChiCTR2400082647.
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BibTeX
@article{ni2026sintilimab,
title = {{Sintilimab plus eribulin and carboplatin in patients with metastatic triple-negative breast cancer (SECURE): a phase II, multicenter trial}},
author = {Mengqian Ni and Lijia Zhou and Lulu Zhang and Yanhong Su and Huadi Shi and Meiting Chen and Qiufang Zheng and Haifeng Li and Daining Wang and Shu Dun and Qingru Zhou and Peng Sun and Lixia Li and Shusen Wang and Yongkui Lu and Yanxia Shi and Xin An},
journal = {Journal for Immunotherapy of Cancer},
year = {2026},
month = oct,
doi = {10.1136/jitc-2026-016269},
url = {https://doi.org/10.1136/jitc-2026-016269},
note = {CC BY-NC 4.0},
}
RIS
TY - JOUR
TI - Sintilimab plus eribulin and carboplatin in patients with metastatic triple-negative breast cancer (SECURE): a phase II, multicenter trial
AU - Mengqian Ni
AU - Lijia Zhou
AU - Lulu Zhang
AU - Yanhong Su
AU - Huadi Shi
AU - Meiting Chen
AU - Qiufang Zheng
AU - Haifeng Li
AU - Daining Wang
AU - Shu Dun
AU - Qingru Zhou
AU - Peng Sun
AU - Lixia Li
AU - Shusen Wang
AU - Yongkui Lu
AU - Yanxia Shi
AU - Xin An
PY - 2026
DA - 2026/10/23
JO - Journal for Immunotherapy of Cancer
DO - 10.1136/jitc-2026-016269
UR - https://doi.org/10.1136/jitc-2026-016269
AB - Background: The clinical benefit of combining chemotherapy with immunotherapy in metastatic triple-negative breast cancer (TNBC) varies depending on the chemotherapy backbone, highlighting the need for optimizing combination partners. This single-arm exploratory phase II trial evaluated the efficacy and safety of sintilimab combined with eribulin and carboplatin (ErCb) in patients with metastatic TNBC previously treated with anthracyclines and/or taxanes. Methods: Eligible patients received eribulin 1.4 mg/m2 and carboplatin (area under the curve=2) on days 1 and 8, plus sintilimab 200 mg on day 8 of each 21-day cycle. The primary endpoint was the objective response rate (ORR). Secondary endpoints included progression-free survival (PFS), overall survival (OS), disease control rate (DCR), and safety. The trial was registered in the Chinese Clinical Trial Registry (No. ChiCTR2400082647). Results: Between February 2024 and March 2025, 27 female patients were enrolled. All patients had received prior treatment with anthracyclines and/or taxane-based chemotherapy. 18 patients (66.7%) had ≥3 metastatic lesions, 19 (70.4%) had visceral metastases, and 5 (18.5%) had brain metastases (BM). The confirmed ORR was 70.4% and DCR was 81.5%. At a median follow-up of 16.2 months, median PFS was 7.6 months; median OS was immature at 19.0 months, with only 33.3% of events reported. Notably, all five patients with BM achieved a partial response in both intracranial and systemic lesions. In an exploratory multivariate analysis, Eastern Cooperative Oncology Group performance status 1, ≥3 metastatic sites, and programmed cell death-ligand 1 negativity were potentially associated with worse PFS. The most common grade ≥3 adverse events (AEs) were neutropenia (48.1%), febrile neutropenia (14.8%), and thrombocytopenia (7.4%), stomatitis (3.7%), and aspartate aminotransferase/aspartate aminotransferase elevation (3.7%). Hypothyroidism (18.5%) was the most common immunotherapy-related adverse event (irAE), with no grade ≥3 irAEs observed. Exploratory biomarker analyses suggested that higher baseline CXCL10, CCL28, CD58, and CD99 levels were associated with longer survival, whereas insulin-like growth factor-binding trended downward at progression. RNA-sequencing data revealed enrichment of the hypoxia-inducible factor 1 (HIF-1) pathway in poor responders and at progression. Conclusion: In this exploratory phase II trial, sintilimab plus ErCb showed promising preliminary antitumor activity and a manageable safety profile in patients with anthracycline-pretreated and/or taxane-pretreated metastatic TNBC. These hypothesis-generating findings support further evaluation in larger, randomized controlled trials. Trial registration number: ChiCTR2400082647.
SN - 2051-1426
ER -