{"preliminary_commentary":{"by_channel":{"podcast":70,"x_thread":57,"youtube":48,"bluesky_thread":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\": \"NCT03043313\", \"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":"ACCRU-GI-1617","nct_id":"NCT03043313","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=accru-gi-1617-nct03043313. 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":1950,"size":"deep","size_rule":"Deep: 301+ verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Non-randomized cohort. Participants take tucatinib twice per day orally on Days 1-21 and trastuzumab intravenously (into the vein; IV) on Day 1. Cycles repeat every 21 days.","label":"Cohort A: Tucatinib + Trastuzumab","type":"EXPERIMENTAL"},{"description":"Randomized cohort. Participants take tucatinib twice per day orally on Days 1-21 and trastuzumab intravenously (into the vein; IV) on Day 1. Cycles repeat every 21 days.","label":"Cohort B: Tucatinib + Trastuzumab","type":"EXPERIMENTAL"},{"description":"Randomized cohort. Participants take tucatinib twice per orally every day. Participants who do not respond to therapy may have the option to receive tucatinib and trastuzumab.","label":"Cohort C: Tucatinib Monotherapy","type":"EXPERIMENTAL"}],"collaborators":["National Cancer Institute (NCI)","Academic and Community Cancer Research United"],"completion_date":{"date":"2023-11-02","type":"ACTUAL"},"conditions":["Metastatic Colorectal Adenocarcinoma"],"enrollment":{"count":117,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Trastuzumab","otherNames":["Herceptin"],"type":"DRUG"},{"name":"Tucatinib","otherNames":["ARRY-380","ONT-380","TUKYSA"],"type":"DRUG"}],"last_update":"2024-11-26","lead_sponsor":"Seagen Inc.","official_title":"MOUNTAINEER: A Phase II, Open Label Study of Tucatinib Combined With Trastuzumab in Patients With HER2+ Metastatic Colorectal Cancer","overall_status":"COMPLETED","phases":["PHASE2"],"primary_completion_date":{"date":"2022-03-28","type":"ACTUAL"},"primary_outcomes":[{"measure":"Confirmed Objective Response Rate (cORR) Per RECIST v1.1 Per Blinded Independent Central Review (BICR) in Pooled Cohorts A+B","timeFrame":"Up to 46.6 months"}],"references":[{"citation":"Zhang D, Taylor A, Zhao JJ, Endres CJ, Topletz-Erickson A. Population Pharmacokinetic Analysis of Tucatinib in Healthy Participants and Patients with Breast Cancer or Colorectal Cancer. Clin Pharmacokinet. 2024 Oct;63(10):1477-1487. doi: 10.1007/s40262-024-01412-0. Epub 2024 Oct 5.","pmid":"39368039","type":"DERIVED"},{"citation":"Strickler JH, Bekaii-Saab TS. A study to learn how well tucatinib plus trastuzumab works for treating participants with metastatic colorectal cancer, and how safe it is: a plain language summary of the MOUNTAINEER study. Future Oncol. 2024 Mar;20(8):409-421. doi: 10.2217/fon-2023-0676. Epub 2023 Nov 8.","pmid":"37941353","type":"DERIVED"},{"citation":"Casak SJ, Horiba MN, Yuan M, Cheng J, Lemery SJ, Shen YL, Fu W, Moore JN, Li Y, Bi Y, Auth D, Fesenko N, Kluetz PG, Pazdur R, Fashoyin-Aje LA. FDA Approval Summary: Tucatinib with Trastuzumab for Advanced Unresectable or Metastatic, Chemotherapy Refractory, HER2-Positive RAS Wild-Type Colorectal Cancer. Clin Cancer Res. 2023 Nov 1;29(21):4326-4330. doi: 10.1158/1078-0432.CCR-23-1041.","pmid":"37318379","type":"DERIVED"},{"citation":"Strickler JH, Cercek A, Siena S, Andre T, Ng K, Van Cutsem E, Wu C, Paulson AS, Hubbard JM, Coveler AL, Fountzilas C, Kardosh A, Kasi PM, Lenz HJ, Ciombor KK, Elez E, Bajor DL, Cremolini C, Sanchez F, Stecher M, Feng W, Bekaii-Saab TS; MOUNTAINEER investigators. Tucatinib plus trastuzumab for chemotherapy-refractory, HER2-positive, RAS wild-type unresectable or metastatic colorectal cancer (MOUNTAINEER): a multicentre, open-label, phase 2 study. Lancet Oncol. 2023 May;24(5):496-508. doi: 10.1016/S1470-2045(23)00150-X.","pmid":"37142372","type":"DERIVED"}],"start_date":{"date":"2017-06-23","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Tucatinib Plus Trastuzumab in Patients With HER2+ Colorectal Cancer","url":"https://clinicaltrials.gov/study/NCT03043313"},"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/accru-gi-1617-nct03043313"}