Would you consider adding adjuvant ribociclib for a patient who has already received 2 years of endocrine therapy and is eligible for ribociclib according to the NATALEE trial?

Since the NATALEE trial excluded patients who received more than 12 months of neoadjuvant or adjuvant endocrine therapy, I would probably not consider ribociclib for your patient, as she is too far out from initiation of endocrine therapy.

In NATALEE, patients could have received at most 12 months of prior adjuvant endocrine therapy before starting ribociclib. The FDA approval is anchored on that evidence base and does not provide data for initiating ribociclib after 2 years of ongoing ET. I would NOT personally recommend Kisqali at t...

NATALEE Trial Overview

• Trial Name: NATALEE (New Adjuvant Trial With Ribociclib [LEE011])
• Phase: III, randomized, open-label, multicenter
• Enrollment: 5,101 patients across 20 countries
• Sponsor: Novartis
• ClinicalTrials.gov ID: NCT03701334

Patient Population

• Eligibility: Adults with stage II or III HR+...

Currently, there are insufficient data to support the efficacy or safety of starting ribociclib after 2 years of endocrine therapy have already been completed. That being said, recommendations for adjuvant CDK4/6 inhibitors should be individualized, but specifically, the clinical benefit of ribocicl...

The biological rationale for this question is whether the micrometastatic disease that has already survived two years of endocrine therapy would remain sensitive to CDK4/6 inhibition or not? Resistance mechanisms to both endocrine therapy and CDK4/6 inhibitors include Rb loss, activation of alternat...

Agree with the above-mentioned comments. I have been basically following the adjuvant CDK4/6 inhibitor studies (monarchE and NATALEE) and using them within 12 months, rarely at the 18-month timepoint. Beyond that, the benefit of these agents may be questionable.

For patients who need adjuvant chemoth...

Check out the rebuttal to this by Conforti and colleagues. (Conforti et al., PMID 40961402)