Therapy Detail
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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 29 | 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 |
|---|---|---|---|---|---|---|
| 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 |
| NCT04657679 | Phase 0 | Fulvestrant + Ribociclib Letrozole + Ribociclib | Pharmacokinetics and Pharmacogenomics of Ribociclib in Race-based Cohorts (LEANORA) | Terminated | 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 | Recruiting | USA | TUR | POL | LBN | ITA | GRC | ESP | BRA | ARG | 12 |
| 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 |
| 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 | SVN | POL | NZL | ITA | ISR | HUN | GRC | FRA | FIN | ESP | DEU | CAN | BRA | BEL | AUT | AUS | ARG | 15 |
| 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) | Active, not 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) | Recruiting | FRA | 0 |
| 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) | Recruiting | USA | ESP | 1 |
| 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 |
| 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 |
| 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 |
| 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 | Completed | 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 |
| 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 |
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