Therapy Detail
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| Therapy Name | Letrozole + Ribociclib |
| Synonyms | |
| Therapy Description | |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| 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|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 |
|---|---|---|---|---|---|---|---|
| RB1 H483Y | Her2-receptor negative breast cancer | predicted - resistant | Letrozole + Ribociclib | Case Reports/Case Series | Actionable | In a clinical case study, RB1 H483Y was identified in the circulating tumor DNA of a patient with estrogen receptor (ESR1)-positive, progesterone receptor (PGR)-positive, and Erbb2 (Her2)-negative, invasive ductal carcinoma at the time of disease progression after 13 months of Kisqali (ribociclib) and Femara (letrozole) combination treatment (PMID: 29236940). | 29236940 |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT03673124 | Phase II | Letrozole + Ribociclib | Ribociclib and Letrozole Treatment in Ovarian Cancer | Active, not recruiting | 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 | Active, not 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| NCT06757634 | Phase III | Fulvestrant + Ribociclib Fulvestrant + Gedatolisib + Palbociclib Gedatolisib + Letrozole + Palbociclib Letrozole + Ribociclib | 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 |
| NCT01958021 | Phase III | Letrozole + Ribociclib Letrozole | Study of Efficacy and Safety of LEE011 in Postmenopausal Women With Advanced Breast Cancer.(MONALEESA-2) | Completed | USA | TUR | SWE | NOR | NLD | LBN | ITA | ISR | IRL | HUN | GBR | FRA | FIN | ESP | DNK | DEU | CZE | CAN | BRA | BEL | AUT | AUS | ARG | 6 |
| 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 |
| 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 |
| NCT02712723 | Phase II | Letrozole + Ribociclib | Letrozole Plus Ribociclib or Placebo as Neo-adjuvant Therapy in ER-positive, HER2-negative Early Breast Cancer (FELINE) | Active, not recruiting | USA | 0 |
| NCT03956654 | FDA approved | Letrozole + Ribociclib | A Phase IV Study to Collect Data on the Efficacy and Safety of RIBociclib in Older Women With Breastcancer (RibOB) | Completed | BEL | 0 |
| 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 |
| 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 |
| NCT04657679 | Phase 0 | Fulvestrant + Ribociclib Letrozole + Ribociclib | Pharmacokinetics and Pharmacogenomics of Ribociclib in Race-based Cohorts (LEANORA) | 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 |
| 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 |
| NCT07492641 | Phase III | Letrozole + Ribociclib BGB-43395 + Letrozole Abemaciclib + Letrozole Letrozole + Palbociclib | BGB-43395 Plus Letrozole Versus CDK4/6i Plus Letrozole for Patients With Advanced or Metastatic HR+/HER2- Breast Cancer Who Have Not Received Prior Treatment for Advanced or Metastatic Disease (KANDELA-302) | Recruiting | USA | AUS | 3 |
| NCT07085767 | Phase III | Palazestrant + Ribociclib Letrozole + Ribociclib | Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer (OPERA-02) | Recruiting | USA | ROU | POL | NLD | ITA | HUN | GRC | GBR | FRA | ESP | DEU | CZE | CAN | BEL | AUT | AUS | 6 |
| NCT06760637 | Phase III | Letrozole + Palbociclib Letrozole + Ribociclib Abemaciclib + Letrozole Letrozole + PF-07220060 | Study of PF-07220060 With Letrozole in Adults With HR-positive HER2-negative Breast Cancer Who Have Not Received Anticancer Treatment for Advanced/Metastatic Disease (FourLight-3) | Active, not recruiting | USA | TUR | SWE | SVK | POL | NLD | ITA | ISR | IRL | HUN | GRC | GBR | FRA | FIN | ESP | DNK | DEU | CZE | CHE | CAN | BRA | BGR | BEL | AUS | ARG | 5 |
| NCT01872260 | Phase I | Alpelisib + Letrozole Alpelisib + Letrozole + Ribociclib Letrozole + Ribociclib | Study of LEE011, BYL719 and Letrozole in Advanced ER+ Breast Cancer | Active, not recruiting | USA | ITA | GBR | FRA | ESP | CHE | AUS | 1 |
| NCT03050398 | Phase III | Letrozole + Ribociclib | A Companion Sample Collection Protocol to Support the Discovery of Breast Cancer Aberrations With Treatment of CDK4/6 Therapy/LEE011/Ribociclib | Terminated | USA | 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) | Terminated | USA | ESP | 1 |
| NCT02941926 | Phase III | Letrozole + Ribociclib Leuprolide Goserelin | Study to Assess the Safety and Efficacy of Ribociclib (LEE011) in Combination With Letrozole for the Treatment of Men and Pre/Postmenopausal Women With HR+ HER2- aBC | Completed | USA | SWE | SVN | SVK | POL | NOR | NLD | LBN | ITA | ISR | HUN | GRC | GBR | FRA | FIN | ESP | DNK | CZE | CAN | BGR | BEL | AUT | ARG | 15 |
| NCT02657928 | Phase II | Letrozole + Ribociclib | Ribociclib and Letrozole in Treating Patients With Relapsed ER Positive Ovarian, Fallopian Tube, Primary Peritoneal, or Endometrial Cancer | Completed | USA | 0 |
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