Therapy Detail

Therapy Name LEE011 + Everolimus + Exemestane
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Everolimus Afinitor RAD001|Zortress mTORC1 Inhibitor 8 Afinitor (everolimus) binds to FKBP-12 and allosterically inhibits mTOR, leading to decreased mTORC1 signaling and potentially resulting in decreased tumor cell growth (PMID: 17766661, PMID: 28400999). Afinitor (everolimus) is FDA approved for use in neuroendocrine tumors of pancreatic, lung or gastrointestinal tract origin, advanced renal cell carcinoma, and in combination with Aromasin (exemestane) in hormone receptor-positive, HER2-negative breast cancer (FDA.gov).
Exemestane Aromasin Aromatase Inhibitor 3 Aromasin (exemestane) is an aromatase inhibitor, which prevents the conversion of androgenic precursors to estrogens (NCI Drug Dictionary).
Ribociclib Kisqali LEE011 CDK4/6 Inhibitor 8 Kisqali (ribociclib) is a dual CDK4/6 inhibitor, which may induce cell cycle arrest and reduce proliferation in cancer cells (PMID: 24045179). Kisqali (ribociclib) is FDA-approved in combination with an aromatase inhibitor in women with hormone receptor-positive, ERBB2 (HER2)-negative breast cancer, and in combination with Faslodex (fulvestrant) in postmenopausal women with hormone receptor-positive, ERBB2 (HER2)-negative 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
NCT02732119 Phase Ib/II LEE011 + Everolimus + Exemestane Study of Ribociclib With Everolimus + Exemestane in HR+ HER2- Locally Advanced/Metastatic Breast Cancer Post Progression on CDK 4/6 Inhibitor. (TRINITI-1) Active, not recruiting
NCT01857193 Phase Ib/II LEE011 + Everolimus + Exemestane Exemestane + Everolimus LEE011 + Exemestane Phase Ib/II Trial of LEE011 With Everolimus (RAD001) and Exemestane in the Treatment of ER+ Her2- Advanced Breast Cancer Active, not recruiting