MONALEESA clinical program: a review of ribociclib use in different clinical settings

Future Oncol. 2019 Aug;15(23):2673-2686. doi: 10.2217/fon-2019-0130. Epub 2019 Jul 15.

Abstract

Ribociclib has received approval in the pre/peri- and postmenopausal disease settings on the basis of the MONALEESA trials. MONALEESA-2 demonstrated that ribociclib plus letrozole significantly improved progression-free survival compared with placebo plus letrozole as first-line therapy in postmenopausal patients with HR-positive, HER2-negative advanced breast cancer. Subsequently, ongoing trials reported significant progression-free survival improvements with ribociclib in combination with either fulvestrant in postmenopausal patients with advanced breast cancer who were either treatment naive or received ≤1 line of prior endocrine therapy in the advanced disease setting (MONALEESA-3) or tamoxifen/nonsteroidal aromatase inhibitor with ovarian function suppression in pre/perimenopausal women (MONALEESA-7). This review summarizes the MONALEESA clinical program. ClinicalTrials.gov identifiers: NCT01958021 (MONALEESA-2), NCT02422615 (MONALEESA-3), NCT02278120 (MONALEESA-7).

Keywords: CDK4/6 inhibitor; MONALEESA-2; MONALEESA-3; MONALEESA-7; breast cancer; postmenopausal; premenopausal; ribociclib.

Publication types

  • Clinical Trial, Phase III
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Adult
  • Aminopyridines / therapeutic use*
  • Antineoplastic Agents / therapeutic use*
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Aromatase Inhibitors / therapeutic use
  • Breast Neoplasms / drug therapy*
  • Cyclin D1 / metabolism
  • Cyclin-Dependent Kinase 4 / antagonists & inhibitors
  • Cyclin-Dependent Kinase 6 / antagonists & inhibitors
  • Estrogens / metabolism
  • Female
  • Fulvestrant / therapeutic use
  • Humans
  • Letrozole / therapeutic use*
  • Middle Aged
  • Postmenopause
  • Progression-Free Survival
  • Purines / therapeutic use*
  • Receptor, ErbB-2 / metabolism
  • Tamoxifen / therapeutic use
  • Young Adult

Substances

  • Aminopyridines
  • Antineoplastic Agents
  • Aromatase Inhibitors
  • CCND1 protein, human
  • Estrogens
  • Purines
  • Tamoxifen
  • Cyclin D1
  • Fulvestrant
  • Letrozole
  • ERBB2 protein, human
  • Receptor, ErbB-2
  • CDK4 protein, human
  • CDK6 protein, human
  • Cyclin-Dependent Kinase 4
  • Cyclin-Dependent Kinase 6
  • ribociclib

Associated data

  • ClinicalTrials.gov/NCT01958021
  • ClinicalTrials.gov/NCT02422615
  • ClinicalTrials.gov/NCT02278120