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|Therapy Name||Goserelin + Letrozole + Ribociclib|
|Drug Name||Trade Name||Synonyms||Drug Classes||Drug Description|
|Goserelin||Zoladex||Goserelin acetate||Zoladex (goserelin) is a synthetic analog of lutenizing hormone-releasing hormone, which causes decreased testosterone production in males and decreased estradiol production in females, and is FDA approved for use in prostate carcinoma (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).|
|Ribociclib||Kisqali||LEE011||CDK4/6 Inhibitor 13||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||Covered Countries||Other Countries|
|NCT02278120||Phase III||Goserelin + Ribociclib + Tamoxifen Goserelin + Tamoxifen Anastrozole + Goserelin Goserelin + Letrozole Goserelin + Letrozole + Ribociclib Anastrozole + Goserelin + Ribociclib||Study of Efficacy and Safety in Premenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer (MONALEESA-7)||Completed||USA | ITA | FRA | ESP | DEU | CAN | BEL | AUS||22|
|NCT03822468||Phase II||Goserelin + Letrozole + Ribociclib Anastrozole + Ribociclib Anastrozole + Goserelin + Ribociclib Letrozole + Ribociclib||Study of 2 Ribociclib Doses in Combination With Aromatase Inhibitors in Women With HR+, HER2- Advanced Breast Cancer (AMALEE)||Active, not recruiting||USA | FRA | DEU | CAN | BEL | AUT||17|