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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
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 | BRA | AUS | ARG 8
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
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
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
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
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
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 | GBR | FRA | ESP | DEU | BEL | AUT 1
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
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
NCT07391774 Phase III Anastrozole + Ribociclib Letrozole + Ribociclib Exemestane + Ribociclib Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial 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
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
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


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