Trial reportInvestigational new drugs2022
Efficacy and safety of mitoxantrone hydrochloride liposome injection in Chinese patients with advanced breast cancer: a randomized, open-label, active-controlled, single-center, phase II clinical trial.
Trial report in Investigational new drugs, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02596373 (A Randomized, Open-label, Positive-controlled, Single-institutional, Phase Ⅱ of Mitoxantrone Hydrochloride Liposome Injection in Advanced Recurrent or Metastatic Breast Cancer), which is not on this map. Cited by 18 papers, 1 of them a synthesis that pooled it.
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.
A Randomized, Open-label, Positive-controlled, Single-institutional, Phase Ⅱ of Mitoxantrone Hydrochloride Liposome Injection in Advanced Recurrent or Metastatic Breast Cancer
Who cites it
18 citing papers in PubMed, 1 synthesis or guideline pooled it, 34 citations in OpenAlex.
- Drug induced hyperpigmentation: systematic review and meta-analysis.Frontiers in medicine · 2026Pooled it
- Ubiquitin-specific protease 11 facilitates the activation and proliferation of renal interstitial fibroblasts through epidermal growth factor receptor signaling pathways.Renal failure · 2026Article
- Engineering smart polymeric lipid nanoparticles for breast cancer: AI-guided formulation design, biological barriers, and translational constraints.Journal of nanobiotechnology · 2026Review
- Mitoxantrone hydrochloride liposome (Lipo-MIT) combined with capecitabine in HER2-negative advanced breast cancer: a dose-escalation, phase I study.BMC medicine · 2026Article
- Targeted Drug Delivery for Breast Cancer using Functionalized Liposomes: Preparation Methods, Challenges, and Clinical Translation.AAPS PharmSciTech · 2025Review
- The Efficacy and Safety of the Addition of Mitoxantrone Hydrochloride Liposome in Conditioning Regimen for High-Risk Acute Myeloid Leukemia.Hematological oncology · 2025Article
- The NET-DNA-CCDC25 inhibitor di-Pal-MTO suppresses tumor progression and promotes the innate immune response.Cellular & molecular immunology · 2025Article
- Efficacy and safety of mitoxantrone hydrochloride liposome-containing regimens in treating refractory/relapsed acute myeloid leukemia.Discover oncology · 2025Article
- Innovative approach to the detection of circulating tumor biomarkers: multi-dimensional application of liposome technology.Lipids in health and disease · 2025Review
- YAP/TAZ-Hippo pathway mediates the tumorigenesis of various cancers through post-translational modification represented by ubiquitination.Cell death discovery · 2025Article
- Determination of Total and Free Plasma Concentration of Liposomal Mitoxantrone and Clinical Application in Adult Patients with Relapsed or Refractory Peripheral T-Cell Lymphoma.Drug design, development and therapy · 2025Article
- Prospects and Challenges of Different Delivery Systems in Breast Tumors Therapy.Breast cancer : basic and clinical research · 2025Review
- Magnetically modified-mitoxantrone mesoporous organosilica drugs: an emergent multimodal nanochemotherapy for breast cancer.Journal of nanobiotechnology · 2024Article
- Safety, tolerability, and pharmacokinetics of mitoxantrone hydrochloride injection for tracing in patients with gastric cancer: a single-blind, single-center, phase I clinical trial.American journal of cancer research · 2024Article
- Remodeling of tumour microenvironment: strategies to overcome therapeutic resistance and innovate immunoengineering in triple-negative breast cancer.Frontiers in immunology · 2024Review
- Case report: Good response to CMOP regimen containing mitoxantrone hydrochloride liposome (PLM60) as induction chemotherapy in patients with angioimmunoblastic T-cell lymphoma.Frontiers in oncology · 2024Article
- Cancer nanomedicine: a review of nano-therapeutics and challenges ahead.RSC advances · 2023Review
- Towards principled design of cancer nanomedicine to accelerate clinical translation.Materials today. Bio · 2022Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThis trial aimed to evaluate the efficacy and safety of mitoxantrone hydrochloride liposome injection (Lipo-MIT) in advanced breast cancer (ABC).
methodsIn this randomized, open-label, active-controlled, single-center, phase II clinical trial, eligible patients were randomized in a ratio of 1:1 to receive Lipo-MIT or mitoxantrone hydrochloride injection (MIT) intravenously. The primary endpoint was objective response rate (ORR). The secondary endpoints were disease control rate (DCR), progression-free survival (PFS), and safety outcomes.
resultsSixty patients were randomized to receive Lipo-MIT or MIT. The ORR was 13.3% (95% confidence interval (CI): 3.8-30.7%) for Lipo-MIT and 6.7% (95% CI: 0.8-22.1%) for MIT. The DCR was 50% (95% CI: 31.3-68.7%) with Lipo-MIT vs. 30% (95% CI: 14.7-49.4%) with MIT. The median PFS was 1.92 months (95% CI: 1.75-3.61) for Lipo-MIT and 1.85 months (95% CI: 1.75-2.02) for MIT. The most common toxicity was myelosuppression. Lipo-MIT resulted in an incidence of 86.7% of leukopenia and 80.0% of neutropenia, which was marginally superior to MIT (96.7% and 96.7%, respectively). Lipo-MIT showed a lower incidence of cardiovascular events (13.3% vs. 20.0%) and increased cardiac troponin T (3.3% vs. 36.7%); but higher incidence of anemia (76.7% vs. 46.7%), skin hyperpigmentation (66.7% vs. 3.3%), and fever (23.3% vs. 10.0%) than MIT. Conclusions The clinical benefit parameters of Lipo-MIT and MIT were comparable. Lipo-MIT provided a different toxicity profile, which might be associated with the altered distribution of the drug. Additional study is needed to elucidate the potential benefit of Lipo-MIT in ABC. CLINICAL
trial registrationThis study is registered with ClinicalTrials.gov (No. NCT02596373) on Nov 4, 2015.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.