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

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 postmenop...

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Bibliographic Details
Published in:Future oncology (London, England) England), 2019-08, Vol.15 (23), p.2673-2686
Main Author: Yardley, Denise A
Format: Article
Language:English
Subjects:
Adolescent
Adult
Aminopyridines - therapeutic use
Antineoplastic Agents - therapeutic use
Antineoplastic Combined Chemotherapy Protocols - therapeutic use
Aromatase Inhibitors - therapeutic use
Brain cancer
Breast cancer
Breast Neoplasms - drug therapy
Cancer therapies
CDK4/6 inhibitor
Cell cycle
Cell division
Chemotherapy
Clinical trials
Cyclin D1 - metabolism
Cyclin-Dependent Kinase 4 - antagonists & inhibitors
Cyclin-Dependent Kinase 6 - antagonists & inhibitors
Estrogens - metabolism
Female
Fulvestrant - therapeutic use
Hormone replacement therapy
Humans
Letrozole - therapeutic use
Medical research
Middle Aged
MONALEESA-2
MONALEESA-3
MONALEESA-7
Oncology
Patients
Pediatrics
Phosphorylation
postmenopausal
Postmenopause
premenopausal
Progression-Free Survival
Purines - therapeutic use
Receptor, ErbB-2 - metabolism
ribociclib
Studies
Tamoxifen - therapeutic use
Targeted cancer therapy
Tumors
Womens health
Young Adult
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Summary: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. identifiers: NCT01958021 (MONALEESA-2), NCT02422615 (MONALEESA-3), NCT02278120 (MONALEESA-7).
ISSN:1479-6694
1744-8301
DOI:10.2217/fon-2019-0130