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Therapy Name Fulvestrant + Ribociclib
Synonyms
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Fulvestrant Faslodex ICI 182,780 Hormone - Anti-estrogens 31 Faslodex (fulvestrant) is a competitive inhibitor of estrogen that binds and deforms estrogen receptors, and causes inhibition of growth in cultured estrogen-sensitive breast cancer cells and is FDA approved for use in patients with hormone receptor-positive breast cancer (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
PTEN loss breast cancer resistant Fulvestrant + Ribociclib Preclinical - Cell culture Actionable In a preclinical study, PTEN-deficient breast cancer cells demonstrated resistance to the combination of Kisqali (ribociclib) and Faslodex (fulvestrant) in culture (PMID: 31594766). 31594766

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT04920708 Phase II Fulvestrant + Ribociclib Fulvestrant + Ipatasertib + Palbociclib Fulvestrant + Palbociclib Abemaciclib + Fulvestrant Fulvestrant, Ipatasertib and CDK4/6 Inhibition in Metastatic ER+/HER2- Breast Cancer Patients Without ctDNA Suppression (FAIM) Recruiting GBR 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
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
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
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 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 ITA | ESP 1
NCT05207709 Phase III Letrozole + Ribociclib Fulvestrant + Palbociclib Letrozole + Palbociclib Fulvestrant + Ribociclib Paclitaxel Ribociclib vs. Palbociclib in Patients With Advanced Breast Cancer Within the HER2-Enriched Intrinsic Subtype (HARMONIA) Active, not recruiting USA | ESP 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
NCT04657679 Phase 0 Fulvestrant + Ribociclib Letrozole + Ribociclib Pharmacokinetics and Pharmacogenomics of Ribociclib in Race-based Cohorts (LEANORA) Terminated USA 0
NCT02088684 Phase Ib/II Buparlisib + Fulvestrant + Ribociclib Fulvestrant + Ribociclib Alpelisib + Fulvestrant + Ribociclib Study of LEE011 With Fulvestrant and BYL719 or BKM120 in Advanced Breast Cancer Completed USA | ITA | GBR | FRA | ESP 3
NCT06757634 Phase III Fulvestrant + Ribociclib Fulvestrant + Gedatolisib + Ribociclib Fulvestrant + Gedatolisib + Palbociclib Fulvestrant + Palbociclib Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2) Recruiting USA | TUR | ROU | POL | ITA | HUN | GRC | FRA | ESP | DEU | CZE | BRA | BGR | BEL | AUS | ARG 6
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
NCT05625087 Phase II Fulvestrant + Ribociclib Alpelisib + Fulvestrant Detection of Tumor DNA in the Blood of Patients Receiving Standard Therapy for Hormone Receptor-positive (HR+) Non-HER2 Expressing (HER2-) Metastatic Breast Cancer as a Tool to Select Those Who May Benefit From the Next Course of Fulvestrant in Combination With Alpelisib or Ribociclib (SAFIR 03) Active, not recruiting FRA 0
NCT06065748 Phase III Fulvestrant + Palbociclib Abemaciclib + Fulvestrant Giredestrant + Ribociclib Giredestrant + Palbociclib Abemaciclib + Giredestrant Fulvestrant + Ribociclib A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer) Recruiting USA | TUR | SVN | ROU | POL | NZL | ITA | ISR | HUN | GRC | FRA | FIN | ESP | DEU | CAN | BRA | BEL | AUT | AUS | ARG 17
NCT06409390 Phase I Fulvestrant + Ribociclib Trastuzumab deruxtecan Sacituzumab govitecan-hziy Capecitabine Abemaciclib + Fulvestrant Cyclophosphamide + Docetaxel + Sargramostim Sequential Therapies Modeled on Evolutionary Dynamics for Breast Cancer Recruiting USA 0
NCT02422615 Phase III Fulvestrant Fulvestrant + Ribociclib Study of Efficacy and Safety of LEE011 in Men and Postmenopausal Women With Advanced Breast Cancer. (MONALEESA-3) Completed USA | TUR | SWE | POL | NOR | NLD | LBN | ITA | HUN | GBR | FRA | ESP | DNK | DEU | CZE | CHE | CAN | BGR | BEL | AUT | AUS 9
NCT06726148 Phase Ib/II ECI830 + Fulvestrant + Ribociclib ECI830 Fulvestrant + Ribociclib ECI830 + Fulvestrant Study of ECI830 Single Agent or in Combination in Patients With Advanced HR+/HER2- Breast Cancer and Other Advanced Solid Tumors Recruiting USA | ITA | ISR | FRA | DNK | DEU | CZE | CAN | AUS 4
NCT02632045 Phase II Fulvestrant + Ribociclib Fulvestrant Study of Efficacy of Ribociclib After Progression on CDK4/6 Inhibition in Patients With HR+ HER2- Advanced Breast Cancer (MAINTAIN) Completed USA 0


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