{"preliminary_commentary":{"by_channel":{"x_thread":2,"podcast":1},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":false},"commentary_summary":null,"drugs_tested":[["ribociclib"]],"indication":"first-line HR-positive HER2-negative advanced breast cancer","name":"AMALEE","nct_id":"NCT03822468","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=amalee-nct03822468. The price is an estimate of verified statements from the commentary indexed so far. Final coverage is set when the report is built. You never pay more than quoted: if the report is delivered at a smaller size, you pay that size's price, and anything paid above it is refunded. 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_rule":"Never more than quoted: the buyer pays the smaller of price_usd and the price the delivered edition is sold at.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":"AMALEE","arms":[{"description":"Ribociclib 400 mg QD 3 weeks on/1 week off + letrozole or anastrozole (+goserelin in premenopausal women)","label":"Ribociclib 400 mg","type":"EXPERIMENTAL"},{"description":"Ribociclib 600 mg QD 3 weeks on/1 week off + letrozole or anastrozole (+ goserelin in premenopausal women)","label":"Ribociclib 600 mg","type":"ACTIVE_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2024-08-30","type":"ACTUAL"},"conditions":["Breast Cancer"],"enrollment":{"count":376,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Ribociclib","otherNames":["LEE011"],"type":"DRUG"},{"name":"Anastrozole","otherNames":[],"type":"DRUG"},{"name":"Letrozole","otherNames":[],"type":"DRUG"},{"name":"Goserelin","otherNames":[],"type":"DRUG"}],"last_update":"2025-10-16","lead_sponsor":"Novartis Pharmaceuticals","official_title":"A Phase II, Multicenter, Randomized, Open-label Study to Evaluate the Safety and Efficacy of 400 mg of Ribociclib in Combination With Non-steroidal Aromatase Inhibitors for the Treatment of Pre- and Postmenopausal Women With Hormone Receptor-positive, HER2-negative Advanced Breast Cancer Who Received no Prior Therapy for Advanced Disease","overall_status":"COMPLETED","phases":["PHASE2"],"primary_completion_date":{"date":"2021-06-11","type":"ACTUAL"},"primary_outcomes":[{"measure":"Overall Response Rate (ORR)","timeFrame":"Up to 23.8 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":"Cardoso F, Jacot W, Kuemmel S, Gupta S, Cruz F, Balaraman R, Ferreira A, Ahola T, Chapko Y, Zhukova L, Chiang W, Li Z, Ji Y, Kaakiou N, Bolotova N, Sparano JA. 600- vs 400-mg First-Line Ribociclib in Hormone Receptor-Positive/ERBB2-Negative Advanced Breast Cancer: The AMALEE Randomized Clinical Trial. JAMA Oncol. 2025 Nov 1;11(11):1356-1363. doi: 10.1001/jamaoncol.2025.3687.","pmid":"40996770","type":"DERIVED"}],"start_date":{"date":"2019-06-11","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Study of 2 Ribociclib Doses in Combination With Aromatase Inhibitors in Women With HR+, HER2- Advanced Breast Cancer","url":"https://clinicaltrials.gov/study/NCT03822468"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.2","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/amalee-nct03822468"}