{"entity":{"id":"nct00630032","kind":"trial","name":"Safety and Efficacy Comparison of Docetaxel and Ixabepilone in Non Metastatic Poor Prognosis Breast Cancer","aka":["TavIx"],"tldr":"A phase 3 trial of Cyclophosphamide, Docetaxel, Epirubicin, Fluorouracil and Ixabepilone in Breast cancer, run by UNICANCER, completed.","summary":"Safety and Efficacy Comparison of Docetaxel and Ixabepilone in Non Metastatic Poor Prognosis Breast Cancer is a phase 3 interventional study registered as NCT00630032 by UNICANCER, with 762 participants recorded, started 2007-09 and reaching its primary completion in 2017-06. Interventions recorded: cyclophosphamide, Docetaxel, epirubicin hydrochloride, fluorouracil, ixabepilone. Conditions recorded: Breast Cancer.\n\nLinked to the drug Ixabepilone because the registry names it among its interventions and Breast cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00630032","url":"https://clinicaltrials.gov/study/NCT00630032"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["cyclophosphamide","docetaxel","epirubicin","fluorouracil","ixabepilone"],"companies":["unicancer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00630032","phase":"3","setting":"Randomized, Open Label, Multicentric Phase III Evaluating the Benefit of a Sequential Regimen Associating FEC 100 and Ixabepilone in Adjuvant Treatment of Non Metastatic, Poor Prognosis Breast Cancer Defined as Triple-negative Tumor [HER2 Negative - ER Negative - PR Negative] or [HER2 Negative and PR Negative] Tumor; in Node Positive or Node Negative Patients.","sponsor":"UNICANCER","started":"2007-09","startedType":"actual","yearReported":2021,"enrolled":762,"enrolledBasis":"registry","outcomes":[{"endpoint":"Percentage of Participants With Disease-free Survival (DFS)","primary":true,"unit":"%","arms":[{"name":"Docetaxel","n":398,"value":78.97,"note":"95% CI 74.53 to 82.73; Figures from the ClinicalTrials.gov results section (first posted 2021-03-16), not from a publication"},{"name":"Ixabepilone","n":364,"value":83.37,"note":"95% CI 79.06 to 86.87"}],"hr":0.8,"ci":[0.59,1.1],"p":"0.175","source":"https://clinicaltrials.gov/study/NCT00630032?tab=results"},{"endpoint":"Overall Survival","unit":"%","arms":[{"name":"Docetaxel","n":398,"value":87,"note":"95% CI 83.13 to 90.03; Figures from the ClinicalTrials.gov results section (first posted 2021-03-16), not from a publication"},{"name":"Ixabepilone","n":364,"value":87.6,"note":"95% CI 83.64 to 90.66"}],"hr":0.97,"ci":[0.67,1.42],"p":"0.8968","source":"https://clinicaltrials.gov/study/NCT00630032?tab=results"}]},"route":"/trials/nct00630032/","neighbours":{"cancer":[{"id":"breast-cancer","kind":"cancer","name":"Breast cancer (all types)","route":"/cancers/breast-cancer/"}],"drug":[{"id":"cyclophosphamide","kind":"drug","name":"Cyclophosphamide","route":"/drugs/cyclophosphamide/"},{"id":"docetaxel","kind":"drug","name":"Docetaxel","route":"/drugs/docetaxel/"},{"id":"epirubicin","kind":"drug","name":"Epirubicin","route":"/drugs/epirubicin/"},{"id":"fluorouracil","kind":"drug","name":"Fluorouracil (5-FU)","route":"/drugs/fluorouracil/"},{"id":"ixabepilone","kind":"drug","name":"Ixabepilone","route":"/drugs/ixabepilone/"}],"company":[{"id":"unicancer","kind":"company","name":"UNICANCER","route":"/companies/unicancer/"}]}}