Therapy Detail

Therapy Name Letrozole + Ribociclib
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
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).
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
RB1 H483Y Her2-receptor negative breast cancer predicted - resistant Letrozole + Ribociclib Clinical Study Actionable In a clinical case study, RB1 H48Y was identified in the circulating tumor DNA of a patient with estrogen receptor positive, progesterone receptor positive, and Erbb2 (Her2)-negative, invasive ductal carcinoma at the time of disease progression after 13 months of Kisqali (ribociclib) and Femara (letrozole) combination treatment (PMID: 29236940). 29236940
Clinical Trial Phase Therapies Title Recruitment Status
NCT02657928 Phase II Letrozole + Ribociclib Ribociclib and Letrozole in Treating Patients With Relapsed ER Positive Ovarian, Fallopian Tube, Primary Peritoneal or Endometrial Cancer Active, not recruiting
NCT02712723 Phase II Letrozole + Ribociclib Letrozole Plus Ribociclib or Placebo as Neo-adjuvant Therapy in ER-positive, HER2-negative Early Breast Cancer Recruiting
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