Trial reportBMC medicine2026
Inetetamab plus camrelizumab and utidelone for pretreated HER2-positive advanced breast cancer: a prospective, single-arm, phase 2 study.
Trial report in BMC medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04681287 (Exploratory Study of Advanced Breast Cancer in HER2 Positive Patients With Failure of Multi-line Therapy Treated by Combination of Inetetamab), which is not on this map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Exploratory Study of Advanced Breast Cancer in HER2 Positive Patients With Failure of Multi-line Therapy Treated by Combination of Inetetamab (Cipterbin) + PD-1 Inhibitor Combined With Utidelone.
Who cites it
1 citing paper in PubMed.
- Efficacy and safety of utidelone in pretreated patients with metastatic breast cancer in China: a multicenter, real-world study.Therapeutic advances in medical oncology · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
20 authors.
Funding
Abstract
backgroundThe efficacy and safety of anti-HER2 therapy and immune checkpoint inhibitors combined with chemotherapy to treat HER2-positive advanced breast cancer that has failed standard HER2-directed therapies is unknown. This study evaluated the efficacy and safety of a novel, fully China-developed combination therapy-comprising inetetamab (an anti-HER2 monoclonal antibody), camrelizumab (an anti-PD-1 antibody), and utidelone (a microtubule inhibitor)-in this treatment-refractory population.
methodsThe ICU study (NCT04681287) was a single-arm, multicentre, phase 2 trial conducted at five centres in China. Patients with HER2-positive MBC who had experienced progression on prior trastuzumab and TKIs were enrolled. The primary endpoint was the 3-month progression-free survival (PFS) rate in the per-protocol population.
resultsA total of 48 patients with a median of three previous systemic therapies for advanced disease (range, 1-4) were enrolled (median follow-up duration 43.0 months). The 3-month PFS rate in 46 patients was 71.67% (95% CI: 59.7-85.9). The most common any-grade treatment-emergent adverse events (TEAEs) were peripheral neuropathy (87.2%, two events were grade 3) and reactive cutaneous capillary endothelial proliferation (57.4%, all grade 1-2). There were no grade 4 or 5 TEAEs.
conclusionsThe combination of inetetamab, camrelizumab, and utidelone demonstrated promising efficacy and a manageable safety profile in heavily pretreated patients with HER2-positive MBC. These findings support this regimen as a viable treatment option in this setting and warrant further investigation in randomized controlled trials.
trial registrationThe study was registered at ClinicalTrials.gov with the identifier NCT04681287.
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