Therapy Detail
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| Therapy Name | Alpelisib + Letrozole |
| Synonyms | |
| Therapy Description | |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Alpelisib | Piqray | BYL719 | PIK3CA inhibitor 18 | 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). |
| Letrozole | Femara | Letrozol | Aromatase Inhibitor 3 | Femara (letrozole) is an aromatase inhibitor, which inhibits estrogen synthesis, and is approved for postmenopausal women with hormone receptor positive breast cancer (FDA.gov). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| PIK3CA E78K PIK3CA E726K PIK3CA D939G | estrogen-receptor positive breast cancer | no benefit | Alpelisib + Letrozole | Phase Ib/II | Actionable | In a Phase Ib trial, an estrogen-receptor positive breast cancer patient harboring PIK3CA mutations, E78K, D939G, and E726K, demonstrated progressive disease when treated with a combination of Femara (letrozole) and Alpelisib (BYL719) (PMID: 27126994). | 27126994 |
| PIK3CA P447_L455del | estrogen-receptor positive breast cancer | predicted - sensitive | Alpelisib + Letrozole | Case Reports/Case Series | Actionable | In a clinical case study, a patient with estrogen-receptor positive breast cancer harboring PIK3CA P447_L455del demonstrated an 11 month sustained response to the combination therapy of Femara (letrozole) and Alpelisib (BYL719) (PMID: 29284706). | 29284706 |
| PTEN R130* | Her2-receptor negative breast cancer | predicted - resistant | Alpelisib + Letrozole | Case Reports/Case Series | Actionable | In a Phase I/II trial, combination of Piqray (Alpelisib) and Femara (letrozole) resulted in no clinical benefit in a patient with hormone receptor positive, ERBB2 (HER2)-negative breast cancer harboring PTEN R130* (PMID: 32864625; NCT01870505). | 32864625 |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT01872260 | Phase I | Alpelisib + Letrozole Alpelisib + Letrozole + Ribociclib Letrozole + Ribociclib | Study of LEE011, BYL719 and Letrozole in Advanced ER+ Breast Cancer | Active, not recruiting | USA | ITA | FRA | ESP | 4 |
| NCT01870505 | Phase I | Alpelisib + Exemestane Alpelisib + Letrozole | BYL719 Plus Letrozole or Exemestane for Patients With Hormone-Receptor Positive Locally-Advanced Unresectable or Metastatic Breast Cancer | Completed | USA | 0 |
| NCT01923168 | Phase II | Buparlisib + Letrozole Letrozole Alpelisib + Letrozole | Study of Letrozole With or Without BYL719 or Buparlisib, for the Neoadjuvant Treatment of Postmenopausal Women | Completed | USA | ITA | ESP | DEU | CAN | BEL | AUT | 10 |
| NCT01791478 | Phase I | Alpelisib + Letrozole | BYL719 and Letrozole in Post-Menopausal Patients With Hormone Receptor-Positive Metastatic Breast Cancer | Active, not recruiting | USA | 0 |
| NCT03056755 | Phase II | Alpelisib + Fulvestrant Alpelisib + Letrozole | Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant or Letrozole, Based on Prior Endocrine Therapy, in Patients With PIK3CA Mutation With Advanced Breast Cancer Who Have Progressed on or After Prior Treatments (BYLieve) | Active, not recruiting | USA | ITA | FRA | ESP | DEU | CAN | BEL | 12 |
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