Therapy Detail
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| Therapy Name | Neratinib + Paclitaxel |
| Synonyms | |
| Therapy Description | |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Neratinib | Nerlynx | HKI-272|PB272 | HER2 Inhibitor 26 | Nerlynx (neratinib) inhibits the ERBB2 (HER2) receptor as well as EGFR, resulting in decreased proliferation of HER2 and EGFR expressing tumor cells (PMID: 15173008). Nerlynx (neratinib) is FDA approved for use in patients with early stage ERBB2 (HER2)-positive breast cancer following Herceptin (trastuzumab)-based therapy, and in combination with Xeloda (capecitabine) in patients with advanced/metastatic ERBB2 (HER2)-positive breast cancer who have received two or more anti-ERBB2 (HER2) regimens (FDA.gov). |
| Paclitaxel | Taxol | 7-Epipaclitaxel | Antimicrotubule Agent 12 BCL2 Family Inhibitor 6 | Taxol (paclitaxel) binds to tubulin to inhibit microtubule disassembly, which results in decreased cell division, and also binds to the anti-apoptotic factor Bcl-2, promoting apoptosis (NCI Drug Dictionary). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| ERBB2 positive | Her2-receptor positive breast cancer | sensitive | Neratinib + Paclitaxel | Phase II | Actionable | In a Phase II trial, Nerlynx (neratinib) plus Taxol (paclitaxel) demonstrated similar efficacy to Herceptin (trastuzumab) plus Taxol (paclitaxel), with an median progression-free survival of 12.9 months, however, potentially decreased CNS metastasis risk, with an incidence of 8.3% (20/242) compared to 17.3% (41/237) in the Herceptin (trastuzumab) plus Taxol (paclitaxel) group (PMID: 27078022). | 27078022 |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT01953926 | Phase II | Neratinib + Trastuzumab Fulvestrant + Neratinib + Trastuzumab Neratinib Neratinib + Paclitaxel | Neratinib HER Mutation Basket Study (SUMMIT) | Recruiting | USA | CAN | 12 |
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