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 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). |
| 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 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 |
| 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 |
| 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 |
|---|---|---|---|---|---|---|
| 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 | NLD | LBN | ITA | ISR | ESP | DEU | CZE | CAN | BRA | BGR | BEL | AUT | AUS | 3 |
| NCT01791478 | Phase I | Alpelisib + Letrozole | BYL719 and Letrozole in Post-Menopausal Patients With Hormone Receptor-Positive Metastatic Breast Cancer | Active, not recruiting | USA | 0 |
| NCT05826964 | Phase II | Everolimus + Fulvestrant Exemestane + Ribociclib Everolimus + Tamoxifen Fulvestrant + Ribociclib Everolimus + Exemestane Abemaciclib + Letrozole Anastrozole + Palbociclib Abemaciclib + Anastrozole Alpelisib + Letrozole Abemaciclib + Exemestane Fulvestrant + Palbociclib Alpelisib + Fulvestrant Letrozole + Palbociclib Exemestane + Palbociclib Anastrozole + Ribociclib Letrozole + Ribociclib Abemaciclib + Fulvestrant | Levels of Circulating Tumor DNA as a Predictive Marker for Early Switch in Treatment for Patients With Metastatic (Stage IV) Breast Cancer | 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 Mutant, HR+, HER2- Advanced Breast Cancer Who Have Progressed on or After Prior Treatments (BYLieve) | Active, not recruiting | USA | NLD | ITA | ISR | GBR | FRA | ESP | DNK | DEU | CAN | BEL | ARG | 7 |
| 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 |
| 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 | GBR | FRA | ESP | CHE | AUS | 1 |
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