{"preliminary_commentary":{"by_channel":{"x_thread":5},"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,"drugs_tested":[["trastuzumab","pertuzumab"]],"indication":"RAS/BRAF wild-type, HER2-positive metastatic colorectal cancer","name":"S1613","nct_id":"NCT03365882","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=s1613-nct03365882. 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":"Patients receive pertuzumab IV over 30-60 minutes and trastuzumab IV over 30-120 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.","label":"Arm I (pertuzumab, trastuzumab)","type":"EXPERIMENTAL"},{"description":"Patients receive cetuximab IV over 60-120 minutes and irinotecan hydrochloride IV over 90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may optionally crossover to Arm I.","label":"Arm II (cetuximab, irinotecan hydrochloride)","type":"EXPERIMENTAL"}],"collaborators":["National Cancer Institute (NCI)"],"completion_date":{"date":"2025-07-01","type":"ACTUAL"},"conditions":["Colon Adenocarcinoma","ERBB2 Gene Amplification","Rectal Adenocarcinoma","Recurrent Colon Carcinoma","Recurrent Rectal Carcinoma","Stage III Colon Cancer AJCC v7","Stage III Rectal Cancer AJCC v7","Stage IIIA Colon Cancer AJCC v7","Stage IIIA Rectal Cancer AJCC v7","Stage IIIB Colon Cancer AJCC v7","Stage IIIB Rectal Cancer AJCC v7","Stage IIIC Colon Cancer AJCC v7","Stage IIIC Rectal Cancer AJCC v7","Stage IV Colon Cancer AJCC v7","Stage IV Rectal Cancer AJCC v7","Stage IVA Colon Cancer AJCC v7","Stage IVA Rectal Cancer AJCC v7","Stage IVB Colon Cancer AJCC v7","Stage IVB Rectal Cancer AJCC v7"],"enrollment":{"count":240,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Cetuximab","otherNames":["Chimeric Anti-EGFR Monoclonal Antibody","Chimeric MoAb C225","Chimeric Monoclonal Antibody C225","Erbitux","IMC-C225"],"type":"BIOLOGICAL"},{"name":"Irinotecan Hydrochloride","otherNames":["Campto","Camptosar","Camptothecin 11","Camptothecin-11","CPT 11","CPT-11","Irinomedac","U-101440E"],"type":"DRUG"},{"name":"Laboratory Biomarker Analysis","otherNames":[],"type":"OTHER"},{"name":"Pertuzumab","otherNames":["2C4","2C4 Antibody","MoAb 2C4","Monoclonal Antibody 2C4","Perjeta","rhuMAb2C4","RO4368451"],"type":"BIOLOGICAL"},{"name":"Trastuzumab","otherNames":["ABP 980","Anti-c-ERB-2","Anti-c-erbB2 Monoclonal Antibody","Anti-ERB-2","Anti-erbB-2","Anti-erbB2 Monoclonal Antibody","Anti-HER2/c-erbB2 Monoclonal Antibody","Anti-p185-HER2","c-erb-2 Monoclonal Antibody","HER2 Monoclonal Antibody","Herceptin","Herceptin Biosimilar PF-05280014","Herceptin Trastuzumab Biosimilar PF-05280014","MoAb HER2","Monoclonal Antibody c-erb-2","Monoclonal Antibody HER2","PF-05280014","rhuMAb HER2","RO0452317","Trastuzumab Biosimilar ABP 980","Trastuzumab Biosimilar PF-05280014"],"type":"BIOLOGICAL"},{"name":"HER-2 testing","otherNames":[],"type":"DEVICE"}],"last_update":"2026-02-10","lead_sponsor":"SWOG Cancer Research Network","official_title":"S1613, A Randomized Phase II Study of Trastuzumab and Pertuzumab (TP) Compared to Cetuximab and Irinotecan (CETIRI) in Advanced/Metastatic Colorectal Cancer (mCRC) With HER-2 Amplification","overall_status":"COMPLETED","phases":["PHASE2"],"primary_completion_date":{"date":"2022-11-01","type":"ACTUAL"},"primary_outcomes":[{"measure":"Progression-free Survival(PFS)","timeFrame":"Up to 3 years post randomization"}],"references":[{"citation":"Raghav KPS, Guthrie KA, Tan B Jr, Denlinger CS, Fakih M, Overman MJ, Dasari NA, Corum LR, Hicks LG, Patel MS, Esparaz BT, Kazmi SM, Alluri N, Colby S, Gholami S, Gold PJ, Chiorean EG, Kopetz S, Hochster HS, Philip PA. Trastuzumab Plus Pertuzumab Versus Cetuximab Plus Irinotecan in Patients With RAS/BRAF Wild-Type, HER2-Positive, Metastatic Colorectal Cancer (S1613): A Randomized Phase II Trial. J Clin Oncol. 2025 Apr 10;43(11):1348-1357. doi: 10.1200/JCO-24-01710. Epub 2025 Jan 6.","pmid":"39761503","type":"DERIVED"}],"start_date":{"date":"2017-11-27","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"S1613, Trastuzumab and Pertuzumab or Cetuximab and Irinotecan Hydrochloride in Treating Patients With Locally Advanced or Metastatic HER2/Neu Amplified Colorectal Cancer That Cannot Be Removed by Surgery","url":"https://clinicaltrials.gov/study/NCT03365882"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.1","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/s1613-nct03365882"}