Trial Profile
A randomized double-blind, placebo-controlled study of ribociclib in combination with fulvestrant for the treatment of men and postmenopausal women with hormone receptor positive, HER2-negative, advanced breast cancer who have received no or only one line of prior endocrine treatment
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 12 Feb 2024
Price :
$35
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At a glance
- Drugs Fulvestrant (Primary) ; Ribociclib (Primary)
- Indications Advanced breast cancer; HER2 negative breast cancer; Male breast cancer
- Focus Registrational; Therapeutic Use
- Acronyms MONALEESA-3
- Sponsors Novartis; Novartis Pharmaceuticals
- 08 Nov 2023 Results of pooled analysis from MONALEESA-2, -3, -7 assessing intrinsic subtypes with OS published in the Clinical Cancer Research
- 04 Sep 2023 Results of pooled analysis from MONALEESA phase III trials assessing potential biomarkers of response to ribociclib published in the Annals of Oncology.
- 31 Aug 2023 Results (At data cutoff ;January 12, 2022) assessing safety and efficacy in postmenopausal women with HR+/HER2- advanced breast cancer receiving first-line ribociclib plus fulvestrant, published in the Breast Cancer Research.