{"preliminary_commentary":{"by_channel":{"x_thread":3},"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":false},"commentary_summary":null,"name":"BRE12-158","nct_id":"NCT02101385","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=bre12-158-nct02101385. 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":null,"arms":[{"description":"Participants randomized to Experimental Arm A will receive an FDA approved drug at standard dose for four cycles (12-16 weeks total duration, depending on cycle length). Clinical and laboratory monitoring and dose-reductions will follow the FDA package insert guidelines.","label":"Arm A (Genomically Directed Monotherapy)","type":"EXPERIMENTAL"},{"description":"Currently no standard therapy has proven efficacy in this patient population and thus observation alone would be considered standard of care. Additional therapy is permitted, however, if deemed appropriate by the treating physician.","label":"Control Arm B (Observation/Standard Therapy)","type":"OTHER"}],"collaborators":["Hoosier Cancer Research Network","Vera Bradley Foundation for Breast Cancer","Walther Cancer Institute","Indiana University"],"completion_date":{"date":"2022-09-09","type":"ACTUAL"},"conditions":["Malignant Neoplasm of Breast","Breast Cancer"],"enrollment":{"count":193,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Genomically Directed Monotherapy","otherNames":[],"type":"DRUG"},{"name":"Observation/Standard Therapy","otherNames":[],"type":"OTHER"}],"last_update":"2023-09-28","lead_sponsor":"Bryan Schneider, MD","official_title":"A Phase II Randomized Controlled Trial of Genomically Directed Therapy After Preoperative Chemotherapy in Patients With Triple Negative Breast Cancer: Hoosier Oncology Group BRE12-158","overall_status":"COMPLETED","phases":["PHASE2"],"primary_completion_date":{"date":"2021-02-21","type":"ACTUAL"},"primary_outcomes":[{"measure":"Percentage of Participants With Two-Year Disease-Free Survival (DFS)","timeFrame":"From C1D1 until death or up to a maximum of 24 months."}],"references":[{"citation":"Xu J, Gao H, Guan X, Meng J, Ding S, Long Q, Yi W. Circulating tumor DNA: from discovery to clinical application in breast cancer. Front Immunol. 2024 Apr 30;15:1355887. doi: 10.3389/fimmu.2024.1355887. eCollection 2024.","pmid":"38745646","type":"DERIVED"},{"citation":"Schneider BP, Jiang G, Ballinger TJ, Shen F, Chitambar C, Nanda R, Falkson C, Lynce FC, Gallagher C, Isaacs C, Blaya M, Paplomata E, Walling R, Daily K, Mahtani R, Thompson MA, Graham R, Cooper ME, Pavlick DC, Albacker LA, Gregg J, Solzak JP, Chen YH, Bales CL, Cantor E, Hancock BA, Kassem N, Helft P, O'Neil B, Storniolo AMV, Badve S, Miller KD, Radovich M. BRE12-158: A Postneoadjuvant, Randomized Phase II Trial of Personalized Therapy Versus Treatment of Physician's Choice for Patients With Residual Triple-Negative Breast Cancer. J Clin Oncol. 2022 Feb 1;40(4):345-355. doi: 10.1200/JCO.21.01657. Epub 2021 Dec 15.","pmid":"34910554","type":"DERIVED"},{"citation":"Radovich M, Jiang G, Hancock BA, Chitambar C, Nanda R, Falkson C, Lynce FC, Gallagher C, Isaacs C, Blaya M, Paplomata E, Walling R, Daily K, Mahtani R, Thompson MA, Graham R, Cooper ME, Pavlick DC, Albacker LA, Gregg J, Solzak JP, Chen YH, Bales CL, Cantor E, Shen F, Storniolo AMV, Badve S, Ballinger TJ, Chang CL, Zhong Y, Savran C, Miller KD, Schneider BP. Association of Circulating Tumor DNA and Circulating Tumor Cells After Neoadjuvant Chemotherapy With Disease Recurrence in Patients With Triple-Negative Breast Cancer: Preplanned Secondary Analysis of the BRE12-158 Randomized Clinical Trial. JAMA Oncol. 2020 Sep 1;6(9):1410-1415. doi: 10.1001/jamaoncol.2020.2295.","pmid":"32644110","type":"DERIVED"}],"start_date":{"date":"2014-04-03","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Randomized Controlled Trial of Genomically Directed Therapy in Patients With Triple Negative Breast Cancer","url":"https://clinicaltrials.gov/study/NCT02101385"},"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/bre12-158-nct02101385"}