Therapy Detail

Contact

Missing content? – Request curation!

Request curation for specific Genes, Variants, or PubMed publications.

Have questions, comments, or suggestions? - Let us know!

Email us at : ckbsupport@genomenon.com

Therapy Name Letrozole + Ribociclib
Synonyms
Therapy Description

Filtering

  • Case insensitive filtering will display rows if any text in any cell matches the filter term
  • Use simple literal full or partial string matches
  • Separate multiple filter terms with a space. Any order may be used (i. e. a b c and c b a are equivalent )
  • Filtering will only apply to rows that are already loaded on the page. Filtering has no impact on query parameters.
  • Use quotes to match on a longer phrase with spaces (i.e. "mtor c1483f")

Sorting

  • Generally, the default sort order for tables is set to be first column ascending; however, specific tables may set a different default sort order.
  • Click on any column header arrows to sort by that column
  • Hold down the Shift key and click multiple columns to sort by more than one column. Be sure to set ascending or descending order for a given column before moving on to the next column.

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).

Filtering

  • Case insensitive filtering will display rows if any text in any cell matches the filter term
  • Use simple literal full or partial string matches
  • Separate multiple filter terms with a space. Any order may be used (i. e. a b c and c b a are equivalent )
  • Filtering will only apply to rows that are already loaded on the page. Filtering has no impact on query parameters.
  • Use quotes to match on a longer phrase with spaces (i.e. "mtor c1483f")

Sorting

  • Generally, the default sort order for tables is set to be first column ascending; however, specific tables may set a different default sort order.
  • Click on any column header arrows to sort by that column
  • Hold down the Shift key and click multiple columns to sort by more than one column. Be sure to set ascending or descending order for a given column before moving on to the next column.

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

Filtering

  • Case insensitive filtering will display rows if any text in any cell matches the filter term
  • Use simple literal full or partial string matches
  • Separate multiple filter terms with a space. Any order may be used (i. e. a b c and c b a are equivalent )
  • Filtering will only apply to rows that are already loaded on the page. Filtering has no impact on query parameters.
  • Use quotes to match on a longer phrase with spaces (i.e. "mtor c1483f")

Sorting

  • Generally, the default sort order for tables is set to be first column ascending; however, specific tables may set a different default sort order.
  • Click on any column header arrows to sort by that column
  • Hold down the Shift key and click multiple columns to sort by more than one column. Be sure to set ascending or descending order for a given column before moving on to the next column.

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
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
NCT04657679 Phase 0 Fulvestrant + Ribociclib Letrozole + Ribociclib Pharmacokinetics and Pharmacogenomics of Ribociclib in Race-based Cohorts (LEANORA) Terminated 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 Completed 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
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
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) Suspended AUS 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
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
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 Recruiting USA 0
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
NCT02712723 Phase II Letrozole + Ribociclib Letrozole Plus Ribociclib or Placebo as Neo-adjuvant Therapy in ER-positive, HER2-negative Early Breast Cancer (FELINE) Unknown status USA 0
NCT03673124 Phase II Letrozole + Ribociclib Ribociclib and Letrozole Treatment in Ovarian Cancer Active, not recruiting USA 0
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
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
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
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
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


Additional content available in CKB BOOST