{"preliminary_commentary":{"by_channel":{"x_thread":8,"youtube":2},"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\": \"NCT04551495\", \"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":"ROSALINE","nct_id":"NCT04551495","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=rosaline-nct04551495. 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":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":"ROSALINE","arms":[{"description":"Subjects will receive four 28-day cycles of letrozole 2.5 mg daily in combination with entrectinib 600 mg daily. Pre-menopausal women will receive goserelin 3.6 mg every 28 days.","label":"Single Arm","type":"EXPERIMENTAL"}],"collaborators":["Hoffmann-La Roche"],"completion_date":{"date":"2025-01","type":"ESTIMATED"},"conditions":["Invasive Lobular Breast Carcinoma","ER+ Breast Cancer","HER2-negative Breast Cancer"],"enrollment":{"count":65,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"Entrectinib","otherNames":[],"type":"DRUG"},{"name":"Letrozole","otherNames":[],"type":"DRUG"},{"name":"Goserelin","otherNames":[],"type":"DRUG"}],"last_update":"2024-12-04","lead_sponsor":"Jules Bordet Institute","official_title":"Neoadjuvant Study of Targeting ROS1 in Combination With Endocrine Therapy in Invasive Lobular Carcinoma of the Breast","overall_status":"UNKNOWN","phases":["PHASE2"],"primary_completion_date":{"date":"2025-01","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Evaluation of the efficacy of endocrine therapy + entrectinib in women with ER+/HER2- early breast cancer of the lobular subtype:Residual Cancer Burden (RCB)","timeFrame":"At surgery"}],"references":[{"citation":"Agostinetto E, Nader-Marta G, Paesmans M, Ameye L, Veys I, Buisseret L, Neven P, Taylor D, Fontaine C, Duhoux FP, Canon JL, Denys H, Coussy F, Chakiba C, Ribeiro JM, Piccart M, Desmedt C, Ignatiadis M, Aftimos P. ROSALINE: a phase II, neoadjuvant study targeting ROS1 in combination with endocrine therapy in invasive lobular carcinoma of the breast. Future Oncol. 2022 Jul;18(22):2383-2392. doi: 10.2217/fon-2022-0358. Epub 2022 Jun 13.","pmid":"35695563","type":"DERIVED"},{"citation":"Okines A, Irfan T, Asare B, Mohammed K, Osin P, Nerurkar A, Smith IE, Parton M, Ring A, Johnston S, Turner NC. Clinical outcomes in patients with triple negative or HER2 positive lobular breast cancer: a single institution experience. Breast Cancer Res Treat. 2022 Apr;192(3):563-571. doi: 10.1007/s10549-021-06432-z. Epub 2022 Feb 4.","pmid":"35119530","type":"DERIVED"}],"start_date":{"date":"2021-01-14","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Neoadjuvant Study of Targeting ROS1 in Combination With Endocrine Therapy in Invasive Lobular Carcinoma of the Breast (ROSALINE)","url":"https://clinicaltrials.gov/study/NCT04551495"},"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/rosaline-nct04551495"}