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Therapy Name | Alpelisib + Nab-paclitaxel |
Synonyms | |
Therapy Description | |
Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
---|---|---|---|---|
Alpelisib | Piqray | BYL719 | PIK3CA inhibitor 24 | Piqray (alpelisib) is a selective PIK3CA inhibitor that blocks activation of the PI3K signaling pathway and inhibits tumor growth (PMID: 23726034). Piqray (alpelisib) is FDA approved in combination with fulvestrant for use in postmenopausal women, and men, with advanced or metastatic hormone receptor (HR)-positive, ERBB2 (HER2)-negative, PIK3CA-mutant breast cancer (FDA.gov). |
Nab-paclitaxel | Abraxane | ABI-007|Paclitaxel Protein-bound | Chemotherapy - Taxane 3 | Abraxane (nab-paclitaxel) is an albumin-stablized version of paclitaxel, which binds microtubules and prevents depolymerization, resulting in decreased cell motility and division (NCI Drug Dictionary). |
Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
---|---|---|---|---|---|---|---|
PIK3CA act mut | Her2-receptor negative breast cancer | predicted - sensitive | Alpelisib + Nab-paclitaxel | Clinical Study - Cohort | Actionable | In a Phase I/II trial, Piqray (Alpelisib) and Abraxane (nab-paclitaxel) combination treatment resulted in improved clinical benefit rate (100% vs 68%; OR=1.47, P=0.013) and median progression-free survival (11.9 vs 7.5 mo.; HR=0.44, P=0.027) and longer median overall survival (26.7 vs. 14.9 mo.; HR=0.59, P=0.19) in patients with ERBB2 (HER2)-negative metastatic breast cancer harboring activating PIK3CA mutations compared to patients without PIK3CA mutations (PMID: 33602685; NCT02379247). | 33602685 |
Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
---|---|---|---|---|---|---|
NCT04251533 | Phase III | Alpelisib + Nab-paclitaxel Nab-paclitaxel | Study Assessing the Efficacy and Safety of Alpelisib + Nab-paclitaxel in Subjects With Advanced TNBC Who Carry Either a PIK3CA Mutation or Have PTEN Loss (EPIK-B3) | Active, not recruiting | USA | TUR | SVN | SVK | POL | NOR | ITA | ISR | HUN | HRV | GBR | FRA | ESP | DEU | CHE | BRA | BGR | AUT | AUS | ARG | 10 |
NCT04216472 | Phase II | Alpelisib + Nab-paclitaxel | Nab-paclitaxel and Alpelisib for the Treatment of Anthracycline Refractory Triple Negative Breast Cancer With PIK3CA or PTEN Alterations | Active, not recruiting | USA | 0 |
NCT02379247 | Phase Ib/II | Alpelisib + Nab-paclitaxel | BYL719 and Nab-Paclitaxel in Locally Recurrent or Metastatic HER-2 Negative Breast Cancer | Completed | USA | 0 |