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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: C2 – Inclusion Criteria
New
Title:

Managed Access Program to Provide Access to Ribociclib, for Locally Advanced or Metastatic Cancer Resistant or Refractory to Available Treatment Options and Candidate for Therapy With a CDK Inhibitor

Excerpt:
...CDK4 amplification or mutation; CDK6 amplification or mutation; Cyclin D1 amplification, Cyclin D3 amplification or p16 (CDKN2A) mutation); OR available data supporting the activity of ribociclib in a specific tumor type (with or without specific patient selection based on biomarkers)...