{"preliminary_commentary":{"by_channel":{"x_thread":15,"youtube":1,"podcast":1},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. A report screens them, searches for more and cites what clinicians said when it is built, so final coverage is set at build."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT05296746\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's free public preview; the full report is still bought."},"name":"RIBOLARIS","nct_id":"NCT05296746","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=ribolaris-nct05296746. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":1250,"size":"standard","size_rule":"Standard: 151–300 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":"RIBOLARIS","arms":[{"description":"Ribociclib (400 mg/day; 3 weeks ON and 1 week OFF) in the adjuvant setting for 33 cycles. Letrozole or other aromatase inhibitor treatment duration must be of at least 5 years","label":"Responder (ROR-low)","type":"EXPERIMENTAL"},{"description":"Adjuvant chemotherapy. 3 regimens are permitted.\n\nRegimen 1:\n\n\\- Doxorubicin 60 mg/m2 IV day 1 (or Epirubicin 75-100 mg/m2) and Cyclophosphamide 600-830 mg/m2 day 1 every 14/21 days for 4 cycles, followed by Paclitaxel 80 mg/m2 every week for 12 weeks or Docetaxel 75-100 mg/m2 every 3 weeks for 12 weeks.\n\nRegimen 2:\n\n\\- Docetaxel 75-100 mg/m2 IV day 1 and Cyclophosphamide 600-830 mg/m2 day 1 every 21 days for 4-6 cycles.\n\nRegimen 3:\n\n\\- Paclitaxel 80 mg/m2 every week for 12 weeks or Docetaxel 75-100 mg/m2 every 3 weeks for 12 weeks followed by Doxorubicin 60 mg/m2 IV day 1 (or Epirubicin 75-100 mg/m2) and Cyclophosphamide 600-830 mg/m2 day 1 every 14/21 days for 4 cycles.\n\nThen, patients will receive ribociclib (400 mg/day; 3 weeks ON and 1 week OFF) in the adjuvant setting for 33 cycles. Letrozole or other aromatase inhibitor treatment duration must be of at least 5 years","label":"Non-responder (ROR-medium/high)","type":"OTHER"}],"collaborators":["Novartis","UNICANCER"],"completion_date":{"date":"2031-12-01","type":"ESTIMATED"},"conditions":["Breast Cancer Stage II"],"enrollment":{"count":1100,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"Ribociclib (neoadjuvant)","otherNames":["Kisqali"],"type":"DRUG"},{"name":"Chemotherapy (adjuvant)","otherNames":[],"type":"DRUG"},{"name":"Ribociclib (adjuvant)","otherNames":["Kisqali"],"type":"DRUG"}],"last_update":"2026-05-14","lead_sponsor":"SOLTI Breast Cancer Research Group","official_title":"Neoadjuvant and Adjuvant Ribociclib and Endocrine Therapy for Clinically High-risk Estrogen Receptor-positive (ER+) and HER2-negative (HER2-) Breast Cancer","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE2"],"primary_completion_date":{"date":"2029-10-01","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Distant metastasis-free survival (DMFS) in the ROR-low cohort (responder cohort)","timeFrame":"Until recurrence (if it happens) for a maximum of 7.5 years of follow-up"}],"references":[{"citation":"Cottu P, Pascual T, Lemonnier J, Hu H, Roux E, Connolly RM, Ma CX, Wolff AC, Crestani T, Tolosa P, Ferrero-Cafiero JM, Mulero-Sanchez A, Salvador F, Villacampa G, Gavila J, de La Motte Rouge T, Prat A. Rationale and trial design of RIBOLARIS: A phase II trial of neoadjuvant and adjuvant ribociclib plus endocrine therapy for clinically high-risk HR+/HER2-negative breast cancer. Ther Adv Med Oncol. 2026 Aug 13;18:17588359261467380. doi: 10.1177/17588359261467380. eCollection 2026.","pmid":"42602220","type":"DERIVED"}],"start_date":{"date":"2022-05-03","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Neoadjuvant and Adjuvant Ribociclib and ET for Clinically High-risk ER+ and HER2- Breast Cancer","url":"https://clinicaltrials.gov/study/NCT05296746"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/ribolaris-nct05296746"}