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Therapy Name Anastrozole + Ribociclib
Synonyms
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Anastrozole Arimidex Anastrozol Aromatase Inhibitor 3 Arimidex (anastrozole) is an aromatase inhibitor, which inhibits estrogen synthesis (PMID: 29719441). Arimidex (anastrozole) is FDA approved for postmenopausal women with hormone receptor-positive early breast cancer or advanced patients who have failed tamoxifen therapy (FDA.gov).
Ribociclib Kisqali LEE011|LEE-011|LEE 011 CDK4/6 Inhibitor 14 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).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT05826964 Phase II Everolimus + Fulvestrant Exemestane + Ribociclib Everolimus + Tamoxifen Fulvestrant + Ribociclib Everolimus + Exemestane Abemaciclib + Letrozole Anastrozole + Palbociclib Abemaciclib + Anastrozole Alpelisib + Letrozole Abemaciclib + Exemestane Fulvestrant + Palbociclib Alpelisib + Fulvestrant Letrozole + Palbociclib Exemestane + Palbociclib Anastrozole + Ribociclib Letrozole + Ribociclib Abemaciclib + Fulvestrant Levels of Circulating Tumor DNA as a Predictive Marker for Early Switch in Treatment for Patients With Metastatic (Stage IV) Breast Cancer Active, not recruiting USA 0
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) Completed USA | SWE | LTU | HUN | FRA | FIN | DEU | CZE | CAN | BRA | BGR | BEL | AUT | ARG 9
NCT05827081 Phase III Exemestane + Leuprolide + Ribociclib Letrozole + Leuprolide + Ribociclib Goserelin + Letrozole + Ribociclib Anastrozole + Ribociclib Anastrozole + Goserelin + Ribociclib Exemestane + Goserelin + Ribociclib Exemestane + Ribociclib Anastrozole + Leuprolide + Ribociclib Letrozole + Ribociclib Phase IIIb Study of Ribociclib + ET in Early Breast Cancer (Adjuvant WIDER) Recruiting USA | TUR | ISR | DEU | CAN | AUS | ARG 8
NCT03555877 Phase II Anastrozole Fulvestrant Fulvestrant + Ribociclib Letrozole Exemestane + Ribociclib Letrozole + Ribociclib Anastrozole + Ribociclib Exemestane Anti-hormonal Therapie With Ribociclib in HR-positive / HER2- Negative Metastatic Breast Cancer (AMICA) Completed DEU 0
NCT05161195 FDA approved Fulvestrant + Ribociclib Ribociclib Ribociclib + Tamoxifen Goserelin + Ribociclib Letrozole + Ribociclib Anastrozole + Ribociclib Roll-over Study to Allow Continued Access to Ribociclib Active, not recruiting USA | TUR | POL | LBN | ITA | GRC | ESP | BRA | ARG 13
NCT06953882 Phase II Goserelin + Ribociclib Letrozole + Ribociclib Anastrozole + Ribociclib Impact of Omitting Chemo Based on Patient's Selection for ER-Positive, HER2-Negative Breast Cancer With Ribociclib and Endocrine Therapy (SELECT) Recruiting USA 0
NCT06486883 Phase II Abemaciclib + Fulvestrant Fulvestrant + Palbociclib Exemestane + Ribociclib Anastrozole + Ribociclib Exemestane + Palbociclib Letrozole + Ribociclib Abemaciclib + Exemestane Letrozole + Palbociclib Fulvestrant + Ribociclib Trastuzumab deruxtecan Abemaciclib + Letrozole Anastrozole + Palbociclib Abemaciclib + Anastrozole Safety and Efficacy of T-DXd vs. CDK4/6i-based ET as First-line Therapy of HR-positive and HER2-low/Ultralow Advanced Breast Cancer Patients Classified as Non-luminal Subtype (PONTIAC) Recruiting POL | ITA | FRA | ESP | DEU | BEL 1
NCT04256941 Phase II Abemaciclib + Fulvestrant Fulvestrant + Palbociclib Letrozole + Palbociclib Fulvestrant + Ribociclib Abemaciclib + Letrozole Anastrozole + Palbociclib Anastrozole + Ribociclib Letrozole + Ribociclib Abemaciclib + Anastrozole Aromatase Inhibitor Therapy With or Without Fulvestrant for the Treatment of HR Positive Metastatic Breast Cancer With an ERS1 Activating Mutation, the INTERACT Study Terminated USA 0
NCT05467891 Phase II Fulvestrant + Ribociclib Anastrozole + Ribociclib Letrozole + Ribociclib Exemestane + Ribociclib Ribociclib and Endocrine Treatment of Physician's Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer (RaPhLRR) Recruiting USA 0
NCT06377852 Phase III Letrozole + Ribociclib Exemestane + Palbociclib Fulvestrant + Ribociclib Anastrozole + Palbociclib Anastrozole + Ribociclib Exemestane + Ribociclib Letrozole + Palbociclib Fulvestrant + Palbociclib The CDK4/6 Inhibitor Dosing Knowledge (CDK) Study Recruiting USA 0
NCT03701334 Phase III Anastrozole + Ribociclib Letrozole + Ribociclib Letrozole Anastrozole Goserelin Goserelin + Ribociclib A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer (NATALEE) Active, not recruiting USA | ROU | POL | ITA | IRL | HUN | GBR | FRA | ESP | DEU | CAN | BRA | BEL | AUT | AUS | ARG 4
NCT03944434 Phase II Anastrozole + Ribociclib Letrozole + Ribociclib Leuprolide Goserelin Triptorelin FACILE: FeAsibility of First-line riboCIclib in oLdEr Patients With Advanced Breast Cancer (FACILE) Active, not recruiting ITA 0


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