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 (
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 (
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 Case Reports/Case Series 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
NCT03673124 Phase II Letrozole + Ribociclib Ribociclib and Letrozole Treatment in Ovarian Cancer Recruiting
NCT02941926 Phase III Letrozole + Ribociclib Leuprolide Goserelin Study to Assess the Safety and Efficacy of Ribociclib (LEE011) in Combination With Letrozole for the Treatment of Men and Pre/Postmenopausal Women With HR+ HER2- aBC Active, not recruiting
NCT01958021 Phase III Letrozole + Ribociclib Letrozole Study of Efficacy and Safety of LEE011 in Postmenopausal Women With Advanced Breast Cancer.(MONALEESA-2) (MONALEESA-2) Active, not recruiting
NCT01872260 Phase I Alpelisib + Letrozole Alpelisib + Letrozole + Ribociclib Letrozole + Ribociclib Study of LEE011, BYL719 and Letrozole in Advanced ER+ Breast 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