Table 5.
Nanoparticles clinically approved or under clinical trial investigation for breast cancer.
| Name of Product | Type of Nanoparticle | Drug/Biomolecule | Specific Indication and Confirmed Benefit | Approval/Clinical trial Status |
|---|---|---|---|---|
| EndoTAG-1 | Liposome | Paclitaxel | HER2-negative relapsed or metastatic TNBC | Phase III |
| LEP-ETU (Liposomal Entrapped Paclitaxel-Easy To Use) | Liposome | Paclitaxel | Metastatic breast cancer | Phase II |
| LIPUSU® | Liposome | Paclitaxel | Metastatic breast cancer | Phase IV |
| nal-IRI | Liposome | Irinotecan | Metastatic breast cancer | Phase I |
| Doxil® (US) Caelyx® (Europe) | PEGylated Liposome | Doxorubicin hydrochloride | Metastatic and advanced breast cancer—reduced cardiac toxicity | Approved |
| Myocet | Non-PEGylated Liposome | Doxorubicin citrate | Metastatic breast cancer Reduced cardiac toxicity |
Approved in Europe and Canada/Phase III US |
| MM-302 | HER2-targetingLiposome | Doxorubicin | HER2-positive, locally advanced/metastatic BC | Phase III |
| 2B3-101 | GSH PEG-liposome | Doxorubicin | Metastatic | Phase II |
| Lipolatin (regulon Inc.) | PEGylated liposome | Cisplatin | Metastatic | Phase III |
| Mitoxantrone HCL Liposome | Liposome | Mitoxantrone | Advanced recurrent/metastatic breast cancer | Phase II |
| ThermoDox® | Heat-activated liposome | Doxorubicin | Refractory chest wall breast cancer | Phase I/II |
| Narekt-102 | PEGylated liposome | Irinotecan | Metastatic | Phase III |
| SPI-077 | Stealth liposomal | Cisplatin | Advanced breast cancer | Phase I/II |
| DEP® docetaxel | PEGylated dendrimer | Docetaxel | Locally advanced or metastatic breast cancer | Phase II |
| NK-105 | mPEG-b-poly (asparticacid) micelles | Paclitaxel | Metastatic or recurrent breast cancer | Phase III |
| Nanoxel M® | PEG-poly (D, L-lactide) | Docetaxel | Metastatic | Phase I |
| Genexol®-PM | Polymeric micelle PEG-poly (D, L-lactide) | Paclitaxel | Metastatic breast cancer. Improved progression-free survival only and not overall survival | Phase III US/(Approved in Europe and South Korea) |
| Abraxane/Nab-paclitaxel | Human serum albumin | Paclitaxel | Metastatic breast cancer. Improved progression-free survival only and not overall survival | Approved by US FDA and EuropeanMedicine Agency in 2005 |
| ABI-008 | Human serum albumin | Docetaxel | Metastatic breast cancer | Phase II |