{"preliminary_commentary":{"by_channel":{"youtube":7,"x_thread":5,"podcast":2},"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":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT02441946\", \"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."},"commentary_summary":null,"drugs_tested":[["abemaciclib","anastrozole"],["abemaciclib"]],"indication":"postmenopausal HR+/HER2- early-stage breast cancer","name":"neoMONARCH","nct_id":"NCT02441946","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=neomonarch-nct02441946. 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":1250,"size":"standard","size_rule":"Standard: 151–300 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":"neoMONARCH","arms":[{"description":"Abemaciclib (150 milligrams \\[mg\\]) was given orally every 12 hours (Q12H) plus anastrozole (1 mg) orally once daily (QD) for 2 weeks. Loperamide was given as a prophylaxis for 4 weeks and then at physician discretion.\n\nAll participants received abemaciclib (150 mg) orally Q12H plus anastrozole (1 mg) QD for an additional 14 weeks. Total treatment duration was 16 weeks.","label":"Abemaciclib + Anastrozole","type":"EXPERIMENTAL"},{"description":"Abemaciclib (150 mg) was given orally Q12H for 2 weeks. Loperamide was given as a prophylaxis for 4 weeks and then at physician discretion.\n\nAll participants received abemaciclib (150 mg) orally Q12H plus anastrozole (1 mg) QD for an additional 14 weeks. Total treatment duration was 16 weeks.","label":"Abemaciclib","type":"EXPERIMENTAL"},{"description":"Anastrozole (1 mg) is given orally QD for 2 weeks.\n\nAll participants received abemaciclib (150 mg) orally Q12H plus anastrozole (1 mg) QD for an additional 14 weeks. Loperamide was given as a prophylaxis for the first 2 weeks of the combination treatment and then at physician discretion. Total treatment duration was 16 weeks.","label":"Anastrozole","type":"ACTIVE_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2018-02-12","type":"ACTUAL"},"conditions":["Breast Cancer","Hormone Receptor Positive Tumor","Early-Stage Breast Carcinoma"],"enrollment":{"count":224,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Abemaciclib","otherNames":["LY2835219"],"type":"DRUG"},{"name":"Loperamide","otherNames":[],"type":"DRUG"},{"name":"Anastrozole","otherNames":[],"type":"DRUG"}],"last_update":"2020-06-17","lead_sponsor":"Eli Lilly and Company","official_title":"neoMONARCH: A Phase 2 Neoadjuvant Trial Comparing the Biological Effects of 2 Weeks of Abemaciclib (LY2835219) in Combination With Anastrozole to Those of Abemaciclib Monotherapy and Anastrozole Monotherapy and Evaluating the Clinical Activity and Safety of a Subsequent 14 Weeks of Therapy With Abemaciclib in Combination With Anastrozole in Postmenopausal Women With Hormone Receptor Positive, HER2 Negative Breast Cancer","overall_status":"COMPLETED","phases":["PHASE2"],"primary_completion_date":{"date":"2016-08-16","type":"ACTUAL"},"primary_outcomes":[{"measure":"Percent Change From Baseline to 2 Weeks in Ki67 Expression","timeFrame":"Baseline, 2 Weeks"}],"references":[{"citation":"Franzoi MA, Lambertini M, Ceppi M, Bruzzone M, de Azambuja E. Implication of body mass index (BMI) on the biological and clinical effects of endocrine therapy plus abemaciclib as neoadjuvant therapy for early breast cancer patients. Breast Cancer Res Treat. 2022 Apr;192(2):457-462. doi: 10.1007/s10549-022-06525-3. Epub 2022 Jan 25.","pmid":"35076812","type":"DERIVED"},{"citation":"Hurvitz SA, Martin M, Press MF, Chan D, Fernandez-Abad M, Petru E, Rostorfer R, Guarneri V, Huang CS, Barriga S, Wijayawardana S, Brahmachary M, Ebert PJ, Hossain A, Liu J, Abel A, Aggarwal A, Jansen VM, Slamon DJ. Potent Cell-Cycle Inhibition and Upregulation of Immune Response with Abemaciclib and Anastrozole in neoMONARCH, Phase II Neoadjuvant Study in HR+/HER2- Breast Cancer. Clin Cancer Res. 2020 Feb 1;26(3):566-580. doi: 10.1158/1078-0432.CCR-19-1425. Epub 2019 Oct 15.","pmid":"31615937","type":"DERIVED"}],"start_date":{"date":"2015-08"},"study_type":"INTERVENTIONAL","title":"A Neoadjuvant Study of Abemaciclib (LY2835219) in Postmenopausal Women With Hormone Receptor Positive, HER2 Negative Breast Cancer","url":"https://clinicaltrials.gov/study/NCT02441946"},"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/neomonarch-nct02441946"}