{"commentary":{"count":11,"free_build_floor":8,"listing_floor":3,"by_channel":{"youtube":7,"x_thread":3,"podcast":1},"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\": \"NCT01426880\", \"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":"GeparSixto","nct_id":"NCT01426880","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=geparsixto-nct01426880. 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":750,"size":"focused","size_rule":"Focused: 1–12 commentary sources"},"registry":{"acronym":"GeparSixto","arms":[{"description":"Carboplatin AUC 2 min/mL weekly, infusion will be used as Add-on to the background therapy (same as comparator arm)","label":"Carboplatin + background treatment","type":"EXPERIMENTAL"},{"description":"background treatment with NLPD (Myocet), Paclitaxel, Herceptin (Trastuzumab fpr Her2 pos), Tyverb (Lapatinib for Her2 pos), Avastin (Bevacizumab for triple negative) agents are used according to marketed formulation via normal procedures at each site and applied according to recommendations of the manufacturers.","label":"background treatment only","type":"ACTIVE_COMPARATOR"}],"collaborators":["Teva Pharmaceuticals USA","Roche Pharma AG","GlaxoSmithKline"],"completion_date":{"date":"2013-08","type":"ACTUAL"},"conditions":["Tubular Breast Cancer Stage II","Mucinous Breast Cancer Stage II","Breast Cancer Female NOS","Invasive Ductal Breast Cancer","Tubular Breast Cancer Stage III","HER-2 Positive Breast Cancer","Inflammatory Breast Cancer Stage IV","Inflammatory Breast Cancer"],"enrollment":{"count":595,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Carboplatin","type":"DRUG"},{"name":"background treatment","type":"DRUG"}],"last_update":"2016-02-15","lead_sponsor":"GBG Forschungs GmbH","official_title":"A Randomized Phase II Trial Investigating the Addition of Carboplatin to Neoadjuvant Therapy for Triple-negative and HER2-positive Early Breast Cancer","overall_status":"COMPLETED","phases":["PHASE2","PHASE3"],"primary_completion_date":{"date":"2013-05","type":"ACTUAL"},"primary_outcomes":[{"measure":"Pathological complete response of breast and lymph nodes (ypT0 ypN0; primary endpoint)","timeFrame":"24 weeks (time window -3 weeks)"}],"references":[{"citation":"Denkert C, von Minckwitz G, Brase JC, Sinn BV, Gade S, Kronenwett R, Pfitzner BM, Salat C, Loi S, Schmitt WD, Schem C, Fisch K, Darb-Esfahani S, Mehta K, Sotiriou C, Wienert S, Klare P, Andre F, Klauschen F, Blohmer JU, Krappmann K, Schmidt M, Tesch H, Kummel S, Sinn P, Jackisch C, Dietel M, Reimer T, Untch M, Loibl S. Tumor-infiltrating lymphocytes and response to neoadjuvant chemotherapy with or without carboplatin in human epidermal growth factor receptor 2-positive and triple-negative primary breast cancers. J Clin Oncol. 2015 Mar 20;33(9):983-91. doi: 10.1200/JCO.2014.58.1967. Epub 2014 Dec 22.","pmid":"25534375","type":"RESULT"},{"citation":"Loibl S, von Minckwitz G, Schneeweiss A, Paepke S, Lehmann A, Rezai M, Zahm DM, Sinn P, Khandan F, Eidtmann H, Dohnal K, Heinrichs C, Huober J, Pfitzner B, Fasching PA, Andre F, Lindner JL, Sotiriou C, Dykgers A, Guo S, Gade S, Nekljudova V, Loi S, Untch M, Denkert C. PIK3CA mutations are associated with lower rates of pathologic complete response to anti-human epidermal growth factor receptor 2 (her2) therapy in primary HER2-overexpressing breast cancer. J Clin Oncol. 2014 Oct 10;32(29):3212-20. doi: 10.1200/JCO.2014.55.7876. Epub 2014 Sep 8.","pmid":"25199759","type":"RESULT"},{"citation":"von Minckwitz G, Schneeweiss A, Loibl S, Salat C, Denkert C, Rezai M, Blohmer JU, Jackisch C, Paepke S, Gerber B, Zahm DM, Kummel S, Eidtmann H, Klare P, Huober J, Costa S, Tesch H, Hanusch C, Hilfrich J, Khandan F, Fasching PA, Sinn BV, Engels K, Mehta K, Nekljudova V, Untch M. Neoadjuvant carboplatin in patients with triple-negative and HER2-positive early breast cancer (GeparSixto; GBG 66): a randomised phase 2 trial. Lancet Oncol. 2014 Jun;15(7):747-56. doi: 10.1016/S1470-2045(14)70160-3. Epub 2014 Apr 30.","pmid":"24794243","type":"RESULT"},{"citation":"Hahnen E, Lederer B, Hauke J, Loibl S, Krober S, Schneeweiss A, Denkert C, Fasching PA, Blohmer JU, Jackisch C, Paepke S, Gerber B, Kummel S, Schem C, Neidhardt G, Huober J, Rhiem K, Costa S, Altmuller J, Hanusch C, Thiele H, Muller V, Nurnberg P, Karn T, Nekljudova V, Untch M, von Minckwitz G, Schmutzler RK. Germline Mutation Status, Pathological Complete Response, and Disease-Free Survival in Triple-Negative Breast Cancer: Secondary Analysis of the GeparSixto Randomized Clinical Trial. JAMA Oncol. 2017 Oct 1;3(10):1378-1385. doi: 10.1001/jamaoncol.2017.1007.","pmid":"28715532","type":"DERIVED"}],"start_date":{"date":"2011-08"},"study_type":"INTERVENTIONAL","title":"Addition of Carboplatin to Neoadjuvant Therapy for Triple-negative and HER2-positive Early Breast Cancer","url":"https://clinicaltrials.gov/study/NCT01426880"},"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/geparsixto-nct01426880"}