{"entity":{"id":"nct03252431","kind":"trial","name":"Neulasta-controlled Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy","aka":[],"tldr":"A phase 3 trial of Efbemalenograstim alfa and Pegfilgrastim in Breast cancer, run by EVIVE Biotechnology, completed.","summary":"Neulasta-controlled Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy is a phase 3 interventional study registered as NCT03252431 by EVIVE Biotechnology, with 393 participants recorded, started 2018-04-12 and reaching its primary completion in 2019-09-25. Interventions recorded: F-627, Neulasta. Conditions recorded: Breast Cancer, Neutropenia.\n\nLinked to the drug Efbemalenograstim alfa 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 NCT03252431","url":"https://clinicaltrials.gov/study/NCT03252431"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-cancer","male-breast-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["efbemalenograstim-alfa","pegfilgrastim"],"companies":["evive-biotech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03252431","phase":"3","setting":"A Phase III, Randomized, Multi-Centre, Open-Label, Fixed Dose, Neulasta® Active-Controlled Clinical Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy","sponsor":"EVIVE Biotechnology","started":"2018-04-12","startedType":"actual","yearReported":2021,"enrolled":393,"enrolledBasis":"registry","outcomes":[{"endpoint":"Duration in Days of Grade 4 Neutropenia in Chemotherapy Cycle 1","primary":true,"unit":"days","arms":[{"name":"F-627","n":197,"value":0.2,"note":"SD 0.51; Figures from the ClinicalTrials.gov results section (first posted 2021-05-07), not from a publication"},{"name":"Neulasta","n":196,"value":0.2,"note":"SD 0.45"}],"source":"https://clinicaltrials.gov/study/NCT03252431?tab=results"}]},"route":"/trials/nct03252431/","neighbours":{"cancer":[{"id":"breast-cancer","kind":"cancer","name":"Breast cancer (all types)","route":"/cancers/breast-cancer/"},{"id":"male-breast-cancer","kind":"cancer","name":"Male breast cancer","route":"/cancers/male-breast-cancer/"}],"drug":[{"id":"efbemalenograstim-alfa","kind":"drug","name":"Efbemalenograstim alfa","route":"/drugs/efbemalenograstim-alfa/"},{"id":"pegfilgrastim","kind":"drug","name":"Pegfilgrastim","route":"/drugs/pegfilgrastim/"}],"company":[{"id":"evive-biotech","kind":"company","name":"Evive Biotech","route":"/companies/evive-biotech/"}]}}