pegylated liposomal doxorubicin

P2, N=60, Not yet recruiting, Beth Israel Deaconess Medical Center

P1, N=30, Recruiting, University of Texas Southwestern Medical Center | Trial completion date: Apr 2026 --> Apr 2029 | Trial primary completion date: Apr 2026 --> Apr 2028

P3, N=1630, Recruiting, Eli Lilly and Company | N=1080 --> 1630 | Trial primary completion date: Apr 2028 --> Nov 2028

P1, N=74, Completed, Zodiac Produtos Farmaceuticos S.A.

P2, N=115, Recruiting, National Cancer Institute (NCI) | Trial completion date: Jun 2026 --> Jun 2027 | Trial primary completion date: Jun 2026 --> Jun 2027

Clinically approved liposomal formulations such as Doxil® (PEGylated doxorubicin) and Myocet® (non-PEGylated doxorubicin) demonstrate improved pharmacokinetic profiles over free drug, yet rely solely on passive tumor accumulation via the enhanced permeability and retention (EPR) effect, an approach rendered insufficient by tumor heterogeneity and variable vascularization, necessitating active targeting strategies. Despite their promise, clinical translation remains constrained by TfR1 receptor saturation, off-target uptake, conjugation-induced immunogenicity, anti-PEG antibody-mediated accelerated blood clearance, and GMP-compliant manufacturing challenges. Overcoming these barriers through pharmacokinetic optimization, standardized quality control, and scalable fabrication is imperative to unlock their full therapeutic potential in breast cancer.

PLD demonstrated modest efficacy in metastatic BC lacking HER2 overexpression, with comparable outcomes in HER2-low and HER2-negative subgroups. These findings suggest that HER2-low status does not predict anthracycline benefit and support the view that HER2-low is unlikely to represent a distinct therapeutic subtype. Further research is needed to refine treatment selection in this heterogeneous population.

In this nationwide propensity score-matched cohort, adjuvant Lipo-Dox was associated with sustained overall survival benefits without increased cardiotoxic risk compared with epirubicin. Lipo-Dox may represent a favorable anthracycline alternative, particularly for patients with cardiovascular comorbidities or elevated cardiotoxicity risk.

P2, N=182, Recruiting, Hebei Medical University Fourth Hospital

Given the advanced stage, the patient received a systemic combination of tislelizumab, cyclophosphamide, pegylated liposomal doxorubicin, and nedaplatin, initially combined with local intrapleural therapy. This case highlights a diagnostic pitfall in lung tumors exhibiting squamoid immunophenotypes and underscores the necessity of incorporating myoepithelial markers into the diagnostic workup. Furthermore, it provides a cautiously interpreted clinical observation of immune checkpoint inhibitor-based combination therapy in advanced PACC.

This study investigated the potential of a fusogenic pH-sensitive liposomal (pSL) nanococktail comprising doxorubicin and bufalin for targeting CSCs in clinically relevant HER2-positive breast cancer models, including cell lines (CD44high HCC1954 and CD44low BT474), homotypic and heterotypic spheroids, patient-derived organoids, and orthotopic HCC1954 mouse xenografts. In vivo, the pSL-cocktail was well-tolerated and achieved significant tumour shrinkage, whereas DOXIL-like liposomes and free drugs showed minimal activity or severe adverse effects. Overall, this pSL-cocktail demonstrates strong potential for CSC-elimination and tumour clearance through synergistic drug combination, superior tumour penetration, and endosomal pH-triggered intracellular drug release.

P1/2, N=52, Recruiting, Fudan University | Trial primary completion date: Aug 2024 --> Aug 2027