Primary results of the exploratory CORALLEEN phase 2 trial showed that neoadjuvant ribociclib and letrozole in high-risk Luminal B breast cancer achieved similar rates of risk of recurrence (ROR)-low disease at surgery as multi-agent chemotherapy. These findings suggest that a chemotherapy-free treatment strategy based on cyclin-dependent kinase (CDK)4/6 inhibition in these patients is worth exploring in future neo(adjuvant) trials.
Although different approaches for treatment de-escalation are being investigated, the current ongoing phase 3 adjuvant trials with CDK4/6 inhibitors are not addressing the question of whether these drugs can replace multi-agent chemotherapy in high-risk early breast cancer. In the CORALLEEN phase 2 trial, the efficacy of ribociclib plus endocrine therapy as neoadjuvant treatment in patients with high-risk Luminal B disease is being assessed . The study was designed as an open-label, parallel, multicentre, two-arm, randomised...
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