{"entity":{"id":"nct00248287","kind":"trial","name":"PhII ICb With/Without Erbitux in MBC Pts","aka":[],"tldr":"A phase 2 trial of Carboplatin and Cetuximab in advanced solid tumours, run by US Oncology Research, active and no longer recruiting.","summary":"PhII ICb With/Without Erbitux in MBC Pts is a phase 2 interventional study registered as NCT00248287 by US Oncology Research, with 154 participants enrolled, started 2005-07-28 and due to reach its primary completion in 2025-12. Interventions recorded: Irinotecan + Carboplatin and irinotecan + Carboplatin + erbitux. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00248287","url":"https://clinicaltrials.gov/study/NCT00248287"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","monoclonal-antibody","platinum"],"targets":[],"drugs":["carboplatin","cetuximab"],"companies":["mckesson-us-oncology","bms","pfizer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00248287","phase":"2","setting":"Randomized Phase II Study of Weekly Irinotecan/Carboplatin (ICb) With or Without Cetuximab (Erbitux) in Patients With Metastatic Breast Cancer","sponsor":"US Oncology Research","started":"2005-07-28","startedType":"actual","yearReported":2016,"enrolled":154,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective Response Rates (ORR)","primary":true,"unit":"%","arms":[{"name":"Irinotecan+Carboplatin","n":66,"value":36.4,"note":"95% CI 24.9 to 49.1; Figures from the ClinicalTrials.gov results section (first posted 2016-11-03), not from a publication"},{"name":"Irinotecan+Carboplatin+Cetuximab","n":71,"value":36.6,"note":"95% CI 25.5 to 48.9"}],"source":"https://clinicaltrials.gov/study/NCT00248287?tab=results"},{"endpoint":"Median Overall Survival (OS)","unit":"months","arms":[{"name":"Irinotecan+Carboplatin","n":75,"value":12.5,"note":"95% CI 10.6 to 17.1; Figures from the ClinicalTrials.gov results section (first posted 2016-11-03), not from a publication"},{"name":"Irinotecan+Carboplatin+Cetuximab","n":79,"value":14.6,"note":"95% CI 10.4 to 16.9"}],"source":"https://clinicaltrials.gov/study/NCT00248287?tab=results"},{"endpoint":"Median Time of Progression-free Survival (PFS)","unit":"months","arms":[{"name":"Irinotecan+Carboplatin","n":75,"value":4.4,"note":"95% CI 3.2 to 5.8; Figures from the ClinicalTrials.gov results section (first posted 2016-11-03), not from a publication"},{"name":"Irinotecan+Carboplatin+Cetuximab","n":79,"value":4.6,"note":"95% CI 3.5 to 5.5"}],"source":"https://clinicaltrials.gov/study/NCT00248287?tab=results"}]},"route":"/trials/nct00248287/","neighbours":{"cancer":[{"id":"metastatic-cancer","kind":"cancer","name":"Metastatic cancer (cancer that has spread)","route":"/cancers/metastatic-cancer/"}],"technology":[{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"},{"id":"monoclonal-antibody","kind":"technology","name":"Monoclonal antibodies","route":"/technologies/monoclonal-antibody/"},{"id":"platinum","kind":"technology","name":"Platinum agents","route":"/technologies/platinum/"}],"drug":[{"id":"carboplatin","kind":"drug","name":"Carboplatin","route":"/drugs/carboplatin/"},{"id":"cetuximab","kind":"drug","name":"Cetuximab","route":"/drugs/cetuximab/"}],"company":[{"id":"bms","kind":"company","name":"Bristol Myers Squibb","route":"/companies/bms/"},{"id":"mckesson-us-oncology","kind":"company","name":"McKesson / The US Oncology Network","route":"/companies/mckesson-us-oncology/"},{"id":"pfizer","kind":"company","name":"Pfizer (incl. Seagen)","route":"/companies/pfizer/"}]}}