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 23 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
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 | GBR | FRA | ESP | DEU | CAN | BEL 10
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
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 | AUS 2
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
NCT01791478 Phase I Alpelisib + Letrozole BYL719 and Letrozole in Post-Menopausal Patients With Hormone Receptor-Positive Metastatic Breast Cancer Active, not recruiting 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 | NLD | ITA | ESP | DEU | CAN | BEL | AUT | AUS 8


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