^
Association details:
Evidence:
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:

Pooled ctDNA analysis of the MONALEESA (ML) phase III advanced breast cancer (ABC) trials.

Published date:
05/13/2020
Excerpt:
Pts with alterations in FRS2 and PRKCA (treatment interaction P< 0.05) as well as MDM2, ERBB2, AKT1, and BRCA1/2 (P> 0.05 but considered actionable) had a trend for increased PFS benefit of RIB vs PBO (Table)….Results of this pooled analysis of the ML-2, 3, and 7 trials, the largest biomarker analysis of any CDK4/6 inhibitor in ABC, revealed several potential biomarkers of response (FRS2, MDM2, PRKCA, ERBB2, AKT1, and BRCA1/2) or resistance (CHD4, BCL11B, ATM, or CDKN2A/2B/2C) to RIB.
DOI:
10.1200/JCO.2020.38.15_suppl.1009
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Pooled ctDNA analysis of MONALEESA phase III advanced breast cancer trials

Published date:
09/04/2023
Excerpt:
Patients with co-amplified FRS2/MDM2 exhibited a greater reduction in disease progression with ribociclib vs placebo (HR, 0.23 [95% CI, 0.11-0.51], P=0.0255)…Median PFS in patients with altered BRCA1/2 was 14.6 months with ribociclib and 8.1 months with placebo...This analysis identified biomarkers that may be associated with of response or resistance to ribociclib that could affect future drug development for patients with ABC.
DOI:
https://doi.org/10.1016/j.annonc.2023.08.011