{"entity":{"id":"nct00099437","kind":"trial","name":"Comparison of Fulvestrant (FASLODEX™) 250 mg and 500 mg in Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy.","aka":["CONFIRM"],"tldr":"A phase 3 trial of Fulvestrant in HR-positive / HER2-negative breast cancer, run by AstraZeneca, active and no longer recruiting.","summary":"Comparison of Fulvestrant (FASLODEX™) 250 mg and 500 mg in Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy. is a phase 3 interventional study registered as NCT00099437 by AstraZeneca, with 736 participants enrolled, started 2005-02-13 and due to reach its primary completion in 2009-02-27. Interventions recorded: Fulvestrant. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00099437","url":"https://clinicaltrials.gov/study/NCT00099437"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-hr-positive"],"sections":[],"technologies":["endocrine-therapy"],"targets":[],"drugs":["fulvestrant"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00099437","phase":"3","setting":"A Randomised, Double-Blind, Parallel-group, Multicentre, Phase III Study Comparing the Efficacy and Tolerability of Fulvestrant (FASLODEX™) 500 mg With Fulvestrant (FASLODEX™) 250 mg in Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy","sponsor":"AstraZeneca","started":"2005-02-13","startedType":"actual","yearReported":2010,"enrolled":736,"enrolledBasis":"registry","outcomes":[{"endpoint":"Time to Progression (TTP)","primary":true,"unit":"months","arms":[{"name":"Fulvestrant 250 mg","n":374,"value":5.5,"note":"range 0 to NA; Figures from the ClinicalTrials.gov results section (first posted 2010-06-15), not from a publication"},{"name":"Fulvestrant 500 mg","n":362,"value":6.5,"note":"range 0 to NA"}],"source":"https://clinicaltrials.gov/study/NCT00099437?tab=results"},{"endpoint":"Overall Survival (OS)","unit":"time (in months)","arms":[{"name":"Fulvestrant 250 mg","n":374,"value":22.8,"note":"range 0.2 to NA; Figures from the ClinicalTrials.gov results section (first posted 2010-06-15), not from a publication"},{"name":"Fulvestrant 500 mg","n":362,"value":25.1,"note":"range 0.1 to NA"}],"source":"https://clinicaltrials.gov/study/NCT00099437?tab=results"},{"endpoint":"Objective Response Rate (ORR)","unit":"%","arms":[{"name":"Fulvestrant 250 mg","n":261,"value":14.6,"note":"Figures from the ClinicalTrials.gov results section (first posted 2010-06-15), not from a publication"},{"name":"Fulvestrant 500 mg","n":240,"value":13.8}],"source":"https://clinicaltrials.gov/study/NCT00099437?tab=results"}]},"route":"/trials/nct00099437/","neighbours":{"cancer":[{"id":"breast-hr-positive","kind":"cancer","name":"HR-positive / HER2-negative breast cancer","route":"/cancers/breast-hr-positive/"}],"technology":[{"id":"endocrine-therapy","kind":"technology","name":"Endocrine therapy (SERMs, AIs, SERDs)","route":"/technologies/endocrine-therapy/"}],"drug":[{"id":"fulvestrant","kind":"drug","name":"Fulvestrant","route":"/drugs/fulvestrant/"}],"company":[{"id":"astrazeneca","kind":"company","name":"AstraZeneca","route":"/companies/astrazeneca/"}]}}