{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,15]],"date-time":"2026-08-15T13:30:51Z","timestamp":1786800651714,"version":"build-2736575974"},"reference-count":79,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2026,8,1]],"date-time":"2026-08-01T00:00:00Z","timestamp":1785542400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2026,8,1]],"date-time":"2026-08-01T00:00:00Z","timestamp":1785542400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"name":"SOLTI, Novartis Pharma AG"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Ther Adv Med Oncol"],"published-print":{"date-parts":[[2026,8]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>Despite advances in endocrine therapy, patients with hormone receptor-positive (HR+)\/human epidermal growth factor receptor 2-negative (HER2\u2212) early breast cancer (eBC) remain at risk of recurrence (ROR). Chemotherapy is often used in high-risk cases, but not all patients benefit.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objectives:<\/jats:title>\n                    <jats:p>To evaluate whether chemotherapy can be safely omitted in patients with stage II, grade 2\/3 HR+\/HER2\u2212 eBC who convert to low genomic risk (ROR-low) following neoadjuvant ribociclib plus letrozole.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>RIBOLARIS (NCT05296746) is an open-label, multicenter phase II trial in patients with stage II, grade 2 or 3, HR+\/HER2\u2212 eBC defined as high risk based on a Ki-67 index \u2a7e20% and\/or high genomic risk by a validated gene expression signature. All patients receive six 28-day cycles of neoadjuvant ribociclib (600\u2009mg\/day, 3\u2009weeks on\/1\u2009week off) plus letrozole (2.5\u2009mg\/day). Following surgery, patients with ROR-low or pathological complete response continue adjuvant ribociclib (400\u2009mg\/day for 30\u2009months) and endocrine therapy (\u2a7e5\u2009years), whereas patients with ROR-medium\/high receive standard chemotherapy followed by ribociclib and endocrine therapy. The primary endpoint is 5-year distant metastasis-free survival (DMFS) in the ROR-low cohort. Interim futility analyses are planned at 300 and 800\u2009patient-years (PYs), with the primary analysis after 1300\u2009PYs. The study targets enrollment of 1100 patients, anticipating 400 ROR-low cases, providing \u2a7e90% power to detect a 5-year DMFS of 96% versus a benchmark of 90.6% (MINDACT trial high-risk subgroup).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Discussion:<\/jats:title>\n                    <jats:p>RIBOLARIS is the first prospective trial to evaluate a chemotherapy-free, ribociclib-based strategy in high-risk HR+\/HER2\u2212 eBC based on neoadjuvant molecular response. By integrating genomic risk reclassification into treatment decision-making, this study aims to demonstrate that patients achieving ROR-low status can maintain excellent long-term outcomes without chemotherapy, while avoiding unnecessary exposure to adjuvant chemotherapy, and to highlight the role of tumor profiling after neoadjuvant endocrine therapy plus cyclin-dependent kinase 4 and 6 inhibitors in optimizing post-neoadjuvant therapy.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration:<\/jats:title>\n                    <jats:p>NCT05296746; EudraCT# 2021-002322-24.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/17588359261467380","type":"journal-article","created":{"date-parts":[[2026,8,13]],"date-time":"2026-08-13T12:13:25Z","timestamp":1786623205000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":0,"title":["Rationale and 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