Therapy Detail

Therapy Name Letrozole + BYL719
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Alpelisib BYL719 PIK3CA inhibitor 14 Alpelisib (BYL719) is a selective PIK3CA inhibitor that blocks activation of the PI3K signaling pathway and inhibits tumor growth (PMID: 23726034).
Letrozole Femara Letrozol Aromatase Inhibitor 3 Femara (letrozole) is an aromatase inhibitor, which inhibits estrogen synthesis (NCI Drug Dictionary). Femara (letrozole) is approved for postmenopausal women with hormone receptor positive breast cancer (FDA.gov).
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
Clinical Trial Phase Therapies Title Recruitment Status
NCT01870505 Phase I BYL719 + Exemestane Letrozole + BYL719 BYL719 Plus Letrozole or Exemestane for Patients With Hormone-Receptor Positive Locally-Advanced Unresectable or Metastatic Breast Cancer Active, not recruiting
NCT03056755 Phase II Alpelisib + Fulvestrant Letrozole + BYL719 Efficacy and Safety of Treatment With Alpelisib Plus Endocrine Therapy in Patients With HR+, HER2-negative aBC, With PIK3CA Mutations, Whose Disease Has Progressed on or After CDK 4/6 Treatment With an Aromatase Inhibitor (AI) or Fulvestrant Recruiting
NCT01923168 Phase II BKM120 + Letrozole Letrozole Letrozole + BYL719 Study of Letrozole With or Without BYL719 or Buparlisib, for the Neoadjuvant Treatment of Postmenopausal Women Completed
NCT01872260 Phase Ib/II Letrozole + BYL719 LEE011 + BYL719 + Letrozole Letrozole + Ribociclib Study of LEE011, BYL719 and Letrozole in Advanced ER+ Breast Cancer Active, not recruiting
NCT01791478 Phase I Letrozole + BYL719 BYL719 and Letrozole in Post-Menopausal Patients With Hormone Receptor-Positive Metastatic Breast Cancer Active, not recruiting