{"commentary":{"count":502,"free_build_floor":8,"listing_floor":3,"by_channel":{"x_thread":329,"youtube":100,"podcast":69,"x_video":4},"note":"Indexed podcasts, YouTube videos and X posts that name this trial. A report screens them, searches for more and cites what clinicians said when it is built."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT03701334\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's public preview; the full report is still bought."},"name":"NATALEE","nct_id":"NCT03701334","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=natalee-nct03701334. The price is fixed at order. We build the report after the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":1950,"size":"deep","size_rule":"Deep: 41+ commentary sources"},"registry":{"acronym":"NATALEE","arms":[{"description":"Eligible participants will receive Ribociclib 400 mg once daily on days 1 to 21 of a 28-day cycle, followed by 7 days off ribociclib (Days 22 to 28).\n\nAnd\n\nEndocrine Therapy (ET) consisting of:\n\n* For postmenopausal women:\n\n  \\- Letrozole 2.5 mg by mouth daily continuously or anastrozole 1 mg by mouth daily continuously.\n* For premenopausal women and men:\n\n  * Letrozole 2.5 mg by mouth daily continuously or anastrozole 1 mg by mouth daily continuously, combined with:\n  * Goserelin 3.6 mg subcutaneously once every 4 weeks.","label":"Ribociclib + Endocrine Therapy (ET)","type":"EXPERIMENTAL"},{"description":"Eligible participants will receive Endocrine Therapy (ET) consisting of:\n\n* For postmenopausal women:\n\n  \\- Letrozole 2.5 mg by mouth daily continuously or anastrozole 1 mg by mouth daily continuously.\n* For premenopausal women and men:\n\n  * Letrozole 2.5 mg by mouth daily continuously or anastrozole 1 mg by mouth daily continuously, combined with:\n  * Goserelin 3.6 mg subcutaneously once every 4 weeks.","label":"Endocrine Therapy (ET)","type":"ACTIVE_COMPARATOR"}],"collaborators":["Translational Research in Oncology"],"completion_date":{"date":"2030-05-29","type":"ESTIMATED"},"conditions":["Early Breast Cancer"],"enrollment":{"count":5101,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Ribociclib","type":"DRUG"},{"name":"Endocrine Therapy (ET)","type":"OTHER"}],"last_update":"2026-10-09","lead_sponsor":"Novartis Pharmaceuticals","official_title":"A Phase III Multi-center, Randomized, Open-label Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as an Adjuvant Treatment in Patients With Hormone Receptor-positive, HER2-negative Early Breast Cancer (New Adjuvant TriAl With Ribociclib [LEE011]: NATALEE)","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE3"],"primary_completion_date":{"date":"2030-05-29","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Invasive Disease-Free Survival (iDFS)","timeFrame":"Up to approximately 139 months"}],"references":[{"citation":"Ji Y, Wang C, Combes FP, Ho YY, Fasching PA, Untch M, Zarate JP, Crown J. Quantitative Pharmacology Justifying Ribociclib Dose in Early Breast Cancer. Clin Pharmacokinet. 2026 Aug;65(8):1217-1228. doi: 10.1007/s40262-026-01643-3. Epub 2026 Jun 23.","pmid":"42334791","type":"DERIVED"},{"citation":"Fasching PA, Stroyakovskiy D, Yardley DA, Huang CS, Crown J, Bardia A, Chia S, Im SA, Martin M, Xu B, Loi S, Barrios C, Untch M, Moroose R, Visco F, Hortobagyi GN, Slamon DJ, Fresco R, Zarate JP, Li Z, Waters S, Hurvitz SA. Ribociclib Plus Endocrine Therapy in Hormone Receptor-Positive/ERBB2-Negative Early Breast Cancer: 4-Year Outcomes From the NATALEE Randomized Clinical Trial. JAMA Oncol. 2025 Nov 1;11(11):1364-1372. doi: 10.1001/jamaoncol.2025.3700.","pmid":"40996773","type":"DERIVED"},{"citation":"Slamon D, Lipatov O, Nowecki Z, McAndrew N, Kukielka-Budny B, Stroyakovskiy D, Yardley DA, Huang CS, Fasching PA, Crown J, Bardia A, Chia S, Im SA, Ruiz-Borrego M, Loi S, Xu B, Hurvitz S, Barrios C, Untch M, Moroose R, Visco F, Afenjar K, Fresco R, Severin I, Ji Y, Ghaznawi F, Li Z, Zarate JP, Chakravartty A, Taran T, Hortobagyi G. Ribociclib plus Endocrine Therapy in Early Breast Cancer. N Engl J Med. 2024 Mar 21;390(12):1080-1091. doi: 10.1056/NEJMoa2305488.","pmid":"38507751","type":"DERIVED"},{"citation":"Slamon DJ, Fasching PA, Hurvitz S, Chia S, Crown J, Martin M, Barrios CH, Bardia A, Im SA, Yardley DA, Untch M, Huang CS, Stroyakovskiy D, Xu B, Moroose RL, Loi S, Visco F, Bee-Munteanu V, Afenjar K, Fresco R, Taran T, Chakravartty A, Zarate JP, Lteif A, Hortobagyi GN. Rationale and trial design of NATALEE: a Phase III trial of adjuvant ribociclib + endocrine therapy versus endocrine therapy alone in patients with HR+/HER2- early breast cancer. Ther Adv Med Oncol. 2023 May 29;15:17588359231178125. doi: 10.1177/17588359231178125. eCollection 2023.","pmid":"37275963","type":"DERIVED"}],"start_date":{"date":"2018-12-07","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer","url":"https://clinicaltrials.gov/study/NCT03701334"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"2.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/natalee-nct03701334"}