{"commentary":{"count":63,"free_build_floor":8,"listing_floor":3,"by_channel":{"podcast":30,"youtube":28,"x_thread":5},"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\": \"NCT03248492\", \"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":"NCT03248492","nct_id":"NCT03248492","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct03248492. 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":null,"arms":[{"description":"T-DM1 resistant/refractory (R/R) patients in the low dose treatment group","label":"DS-8201a Low Dose","type":"EXPERIMENTAL"},{"description":"T-DM1 resistant/refractory (R/R) patients in the medium dose treatment group","label":"DS-8201a Medium Dose","type":"EXPERIMENTAL"},{"description":"T-DM1 resistant/refractory (R/R) patients in the high dose treatment group","label":"DS-8201a High Dose","type":"EXPERIMENTAL"},{"description":"In Part 2b- Continuation Stage, about 10 T-DM1 Intolerant patients will receive the DS-8201a recommended dose (RD) as an exploratory arm","label":"Exploratory Arm","type":"OTHER"}],"collaborators":["AstraZeneca","Daiichi Sankyo Co., Ltd."],"completion_date":{"date":"2024-05-06","type":"ACTUAL"},"conditions":["Breast Cancer"],"enrollment":{"count":253,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"DS-8201a","type":"DRUG"}],"last_update":"2025-06-26","lead_sponsor":"Daiichi Sankyo","official_title":"A Phase 2, Multicenter, Open-Label Study of DS-8201a, an Anti-HER2-Antibody Drug Conjugate (ADC) for HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With T-DM1 (DESTINY-Breast01)","overall_status":"TERMINATED","phases":["PHASE2"],"primary_completion_date":{"date":"2019-03-21","type":"ACTUAL"},"primary_outcomes":[{"measure":"Objective Response Rate as Confirmed by Independent Central Review Following Intravenous Administration of 5.4 mg/kg DS-8201a in Participants With Metastatic Breast Cancer (Enrolled Analysis Set)","timeFrame":"at least 6 months after last participant enrolled received first dose up to 19 months (data cut off)"}],"references":[{"citation":"Dunton K, Vondeling G, Hancock E, Petrou M, Burn O, Paine A. Methods for Estimating Long-Term Outcomes for Trastuzumab Deruxtecan in HER2-Positive Unresectable or Metastatic Breast Cancer After Two or More Anti-HER2 Therapies. Target Oncol. 2022 Nov;17(6):655-663. doi: 10.1007/s11523-022-00923-9. Epub 2022 Nov 7.","pmid":"36342619","type":"DERIVED"},{"citation":"Rugo HS, Bianchini G, Cortes J, Henning JW, Untch M. Optimizing treatment management of trastuzumab deruxtecan in clinical practice of breast cancer. ESMO Open. 2022 Aug;7(4):100553. doi: 10.1016/j.esmoop.2022.100553. Epub 2022 Aug 11.","pmid":"35964548","type":"DERIVED"},{"citation":"Bardia A, Harnden K, Mauro L, Pennisi A, Armitage M, Soliman H. Clinical Practices and Institutional Protocols on Prophylaxis, Monitoring, and Management of Selected Adverse Events Associated with Trastuzumab Deruxtecan. Oncologist. 2022 Aug 5;27(8):637-645. doi: 10.1093/oncolo/oyac107.","pmid":"35642907","type":"DERIVED"},{"citation":"Modi S. Trastuzumab deruxtecan in previously treated HER2-positive metastatic breast cancer: Plain language summary of the DESTINY-Breast01 study. Future Oncol. 2021 Sep 1;17(26):3415-3423. doi: 10.2217/fon-2021-0427. Epub 2021 Jul 15.","pmid":"34263665","type":"DERIVED"},{"citation":"Yin O, Iwata H, Lin CC, Tamura K, Watanabe J, Wada R, Kastrissios H, AbuTarif M, Garimella T, Lee C, Zhang L, Shahidi J, LaCreta F. Exposure-Response Relationships in Patients With HER2-Positive Metastatic Breast Cancer and Other Solid Tumors Treated With Trastuzumab Deruxtecan. Clin Pharmacol Ther. 2021 Oct;110(4):986-996. doi: 10.1002/cpt.2291. Epub 2021 Jun 10.","pmid":"33999422","type":"DERIVED"},{"citation":"Modi S, Saura C, Yamashita T, Park YH, Kim SB, Tamura K, Andre F, Iwata H, Ito Y, Tsurutani J, Sohn J, Denduluri N, Perrin C, Aogi K, Tokunaga E, Im SA, Lee KS, Hurvitz SA, Cortes J, Lee C, Chen S, Zhang L, Shahidi J, Yver A, Krop I; DESTINY-Breast01 Investigators. Trastuzumab Deruxtecan in Previously Treated HER2-Positive Breast Cancer. N Engl J Med. 2020 Feb 13;382(7):610-621. doi: 10.1056/NEJMoa1914510. Epub 2019 Dec 11.","pmid":"31825192","type":"DERIVED"}],"start_date":{"date":"2017-08-25","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study of DS-8201a in Metastatic Breast Cancer Previously Treated With Trastuzumab Emtansine (T-DM1)","url":"https://clinicaltrials.gov/study/NCT03248492"},"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/nct03248492"}