{"id":225786,"date":"2025-11-24T13:23:41","date_gmt":"2025-11-24T19:23:41","guid":{"rendered":"https:\/\/lifeboat.com\/blog\/2025\/11\/ribociclib-plus-endocrine-therapy-in-hormone-receptor-positive-erbb2-negative-early-breast-cancer-4-year-outcomes-from-the-natalee-randomized-clinical-trial"},"modified":"2025-11-24T13:23:41","modified_gmt":"2025-11-24T19:23:41","slug":"ribociclib-plus-endocrine-therapy-in-hormone-receptor-positive-erbb2-negative-early-breast-cancer-4-year-outcomes-from-the-natalee-randomized-clinical-trial","status":"publish","type":"post","link":"https:\/\/lifeboat.com\/blog\/2025\/11\/ribociclib-plus-endocrine-therapy-in-hormone-receptor-positive-erbb2-negative-early-breast-cancer-4-year-outcomes-from-the-natalee-randomized-clinical-trial","title":{"rendered":"Ribociclib Plus Endocrine Therapy in Hormone Receptor\u2013Positive\/ERBB2-Negative Early Breast Cancer: 4-Year Outcomes From the NATALEE Randomized Clinical Trial"},"content":{"rendered":"

<\/a><\/p>\n

In a 4-year analysis of the NATALEE trial, adjuvant ribociclib plus NSAI continued to provide invasive disease-free survival benefit over NSAI alone in patients with hormone receptor\u2013positive\/ERBB2-negative early breast cancer, with stable safety outcomes observed.<\/p>\n

\n

This exploratory 4-year analysis demonstrated a consistent iDFS benefit with ribociclib plus NSAI with additional follow-up, with a 28.5% reduction in the risk of recurrence over NSAI alone and confidence intervals that continue to narrow. The absolute improvement in iDFS with ribociclib plus NSAI continued to increase from 2.7% at 3 years to 4.9% at 4 years. The iDFS, DDFS, RFS, and DRFS benefits were observed with ribociclib plus NSAI over NSAI alone beyond the planned 3-year ribociclib treatment duration, as all patients were no longer receiving ribociclib treatment at the data cutoff. A sustained iDFS benefit with ribociclib plus NSAI was seen across subgroups, including anatomic stage and nodal status, with a consistent reduction in risk of distant recurrences across subgroups. The safety profile remained unchanged with additional follow-up.<\/p>\n

In prior analyses, an iDFS benefit was observed with ribociclib plus NSAI over NSAI alone.10<\/a><\/sup>,21<\/a><\/sup> However, at the time of those analyses, all patients had not yet discontinued ribociclib treatment (54.0% in the second interim efficacy analysis and 78.3% in the protocol-specified final analysis were no longer receiving treatment).10<\/a><\/sup>,21<\/a><\/sup> Thus, the efficacy of ribociclib beyond the planned treatment period was unknown. In this analysis, all patients had stopped ribociclib treatment, with 62.8% of patients having completed the planned 3-year treatment duration. At 4 years, the absolute improvement in iDFS increased and the Kaplan-Meier curves continue to separate with additional follow-up, suggesting a persistent benefit of adjuvant ribociclib beyond the planned 3-year treatment duration.<\/p>\n

An iDFS benefit was observed with ribociclib plus NSAI over NSAI alone in patients with high-risk N0 disease. While this subgroup of patients in NATALEE do not have nodal involvement, enrolled patients with stage IIA node-negative (T2N0) disease were required to have additional high-risk features, including grade 3 disease or grade 2 disease with Ki-67 20% or higher or high genomic risk. Previous meta-analyses and population-based studies have shown risk of recurrence across patients with and without nodal involvement; however, many of the patient samples in these studies were enrolled decades prior to the follow-up analyses.5<\/sup>, 24<\/sup> The cohorts in these long-term studies may not be reflective of contemporary treatment standards, which has the potential to overinflate the recurrence risk among some subgroups.<\/p>\n","protected":false},"excerpt":{"rendered":"

In a 4-year analysis of the NATALEE trial, adjuvant ribociclib plus NSAI continued to provide invasive disease-free survival benefit over NSAI alone in patients with hormone receptor\u2013positive\/ERBB2-negative early breast cancer, with stable safety outcomes observed. This exploratory 4-year analysis demonstrated a consistent iDFS benefit with ribociclib plus NSAI with additional follow-up, with a 28.5% reduction [\u2026]<\/p>\n","protected":false},"author":662,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[11],"tags":[],"class_list":["post-225786","post","type-post","status-publish","format-standard","hentry","category-biotech-medical"],"_links":{"self":[{"href":"https:\/\/lifeboat.com\/blog\/wp-json\/wp\/v2\/posts\/225786","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/lifeboat.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/lifeboat.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/lifeboat.com\/blog\/wp-json\/wp\/v2\/users\/662"}],"replies":[{"embeddable":true,"href":"https:\/\/lifeboat.com\/blog\/wp-json\/wp\/v2\/comments?post=225786"}],"version-history":[{"count":0,"href":"https:\/\/lifeboat.com\/blog\/wp-json\/wp\/v2\/posts\/225786\/revisions"}],"wp:attachment":[{"href":"https:\/\/lifeboat.com\/blog\/wp-json\/wp\/v2\/media?parent=225786"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/lifeboat.com\/blog\/wp-json\/wp\/v2\/categories?post=225786"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/lifeboat.com\/blog\/wp-json\/wp\/v2\/tags?post=225786"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}