{"preliminary_commentary":{"by_channel":{"youtube":17,"podcast":16,"x_thread":5,"x_video":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\": \"NCT05629585\", \"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":"TROPION-Breast03","nct_id":"NCT05629585","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=tropion-breast03-nct05629585. The price is an estimate of verified HCP 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 HCP statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Arm 1: Dato-DXd 6 mg/kg IV Q3W x 8 cycles + Durvalumab 1120 mg IV Q3W x 9 cycles","label":"Dato-DXd in combination with Durvalumab","type":"EXPERIMENTAL"},{"description":"Arm 2: Dato-DXd 6 mg/kg IV Q3W x 8 cycles","label":"Dato-DXd","type":"EXPERIMENTAL"},{"description":"Arm 3: Capecitabine (1000 or 1250 mg/m2 oral BID on Days 1 to 14, Q3W) for 8 cycles\n\nPembrolizumab\\* (200 mg IV on Day 1, Q3W) for 9 cycles\n\nCapecitabine (1000 or 1250 mg/m2 oral BID on Days 1 to 14, Q3W) for 8 cycles + pembrolizumab\\* (200 mg IV on Day 1, Q3W) for 9 cycles\n\n\\* Only participants who have received prior pembrolizumab in the neoadjuvant setting should receive pembrolizumab as part of their adjuvant therapy on Arm 3.","label":"Investigators Choice Therapy","type":"ACTIVE_COMPARATOR"}],"collaborators":["Daiichi Sankyo","SWOG Clinical Trials Partnerships, LLC"],"completion_date":{"date":"2030-02-28","type":"ESTIMATED"},"conditions":["Breast Cancer"],"enrollment":{"count":1174,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Dato-DXd","otherNames":["Datopotamab deruxtecan (Dato-DXd, DS-1062a)"],"type":"DRUG"},{"name":"Durvalumab","otherNames":["MEDI4736"],"type":"DRUG"},{"name":"Capecitabine","otherNames":["XELODA®, Capecitabine Cell Pharm, Capecitabine EG, Capecitabine Accord"],"type":"DRUG"},{"name":"Pembrolizumab","otherNames":["KEYTRUDA®"],"type":"DRUG"}],"last_update":"2026-10-14","lead_sponsor":"AstraZeneca","official_title":"A Phase 3 Open-label, Randomised Study of Datopotamab Deruxtecan (DatoDXd) With or Without Durvalumab Versus Investigator's Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Who Have Residual Invasive Disease in the Breast and/or Axillary Lymph Nodes at Surgical Resection Following Neoadjuvant Systemic Therapy (TROPION-Breast03)","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE3"],"primary_completion_date":{"date":"2027-09-01","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Invasive disease-free survival (iDFS) for Dato-DXd + durvalumab vs. ICT","timeFrame":"From randomisation to date of the event, up to 57 months from first subject in"}],"references":[{"citation":"Bardia A, Pusztai L, Albain K, Ciruelos EM, Im SA, Hershman D, Kalinsky K, Isaacs C, Loirat D, Testa L, Tokunaga E, Wu J, Dry H, Barlow W, Kozarski R, Maxwell M, Harbeck N, Sharma P. TROPION-Breast03: a randomized phase III global trial of datopotamab deruxtecan +/- durvalumab in patients with triple-negative breast cancer and residual invasive disease at surgical resection after neoadjuvant therapy. Ther Adv Med Oncol. 2024 Apr 29;16:17588359241248336. doi: 10.1177/17588359241248336. eCollection 2024.","pmid":"38686016","type":"DERIVED"}],"start_date":{"date":"2022-11-28","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study of Dato-DXd With or Without Durvalumab Versus Investigator's Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Without Pathological Complete Response Following Neoadjuvant Therapy (TROPION-Breast03)","url":"https://clinicaltrials.gov/study/NCT05629585"},"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/tropion-breast03-nct05629585"}