ArticleBMC medicine2026
Mitoxantrone hydrochloride liposome (Lipo-MIT) combined with capecitabine in HER2-negative advanced breast cancer: a dose-escalation, phase I study.
Article 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 NCT06156761 (Clinical Study of Mitoxantrone Hydrochloride Liposome Injection Combined With Capecitabine in Patients With HER-2 Negative Advanced Breast Cancer), which is not on this map. Not yet cited in PubMed.
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Clinical Study of Mitoxantrone Hydrochloride Liposome Injection Combined With Capecitabine in Patients With HER-2 Negative Advanced Breast Cancer
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13 authors.
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Abstract
backgroundPatients with HER2-negative advanced breast cancer (ABC) have limited chemotherapy options after progression on anthracyclines and taxanes. Mitoxantrone Hydrochloride Liposome (Lipo-MIT), a nanoparticle formulation with a 60-nm particle size, is designed to reduce toxicity and enhance tumor targeting. We investigated the safety and efficacy of Lipo-MIT combined with capecitabine in pretreated HER2-negative ABC.
methodsIn this phase I dose-escalation study, eligible patients were sequentially enrolled to receive escalating doses of Lipo-MIT (ranging from 16 to 24 mg/m2) administered either every 3 weeks (Q3W) or every 4 weeks (Q4W), combined with standard capecitabine. Primary endpoints included dose-limiting toxicities (DLTs) and determination of the recommended phase 2 dose (RP2D). Secondary endpoints assessed safety and preliminary efficacy.
resultsTwenty-six patients were enrolled. Lipo-MIT 22 mg/m2 administered Q4W was identified as the RP2D. The combination demonstrated a manageable safety profile, with no reports of severe cardiac toxicity or hand-foot syndrome. Interstitial lung disease was observed in 19.2% of patients, all of which were manageable and low-grade (Grade 1–2). In a post hoc, exploratory analysis, the objective response rate (ORR) was 36.4% in the Q4W cohort and 13.3% in the Q3W cohort. The Q4W regimen yielded a median progression-free survival (mPFS) of 12.7 months (95% CI, 9.3–NR), which was numerically longer than the mPFS of 5.4 months observed in the Q3W cohort, albeit in the context of a sequential design and baseline imbalances.
conclusionsThe combination of Lipo-MIT and capecitabine showed preliminary antitumor activity and manageable tolerability in heavily pretreated HER2-negative ABC. While the Q4W dosing schedule (22 mg/m²) yielded numerically longer PFS, this comparison is based on a non-randomized, sequential cohort design; thus, all inter-cohort efficacy findings are strictly exploratory and hypothesis-generating. Further evaluation in phase II/III trials as a potential later-line strategy. CLINICAL
trial registrationNCT06156761.
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