{"entity":{"id":"nct05552001","kind":"trial","name":"Safety and Efficacy Analysis of an Antibody Associated With a Chemotherapy for Patients With a Triple Negative Metastatic Breast Cancer","aka":["ISIdE"],"tldr":"A phase 3 trial of sacituzumab govitecan in triple-negative breast cancer, run by UNICANCER, active but no longer recruiting.","summary":"Safety and Efficacy Analysis of an Antibody Associated With a Chemotherapy for Patients With a Triple Negative Metastatic Breast Cancer is a phase 3, interventional study registered as NCT05552001 by UNICANCER, with a registry enrolment figure of 96 participants, started 2023-10-05 and due to reach its primary completion in 2026-10-01. Interventions recorded: Sacituzumab govitecan. Conditions listed: Triple Negative Breast Cancer; Metastatic Breast Cancer. Triple-negative eligibility wording from the registry: \"Patients with pathologically documented locally advanced inoperable or metastatic triple negative breast cancer (mTNBC) whose disease has progressed on (neo)adjuvant chemotherapy+/-immunotherapy for early TNBC or within 6 months after the end of any systemic therapy, surgery or radiotherapy with cur\". Sites: France. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05552001","url":"https://clinicaltrials.gov/study/NCT05552001"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early","tnbc-metastatic"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["sacituzumab-govitecan"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05552001","phase":"3","setting":"ISIdE: Open Label, Multicentric, Single-arm Phase IIIB Trial to Evaluate the Safety and Efficacy of Sacituzumab Govitecan in Triple Negative Metastatic Breast Cancer Patients With a Biomarker Analysis","sponsor":"UNICANCER","enrolled":96,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct05552001/","neighbours":{"cancer":[{"id":"tnbc-early","kind":"cancer","name":"Early triple-negative breast cancer","route":"/cancers/tnbc-early/"},{"id":"tnbc-metastatic","kind":"cancer","name":"Metastatic triple-negative breast cancer","route":"/cancers/tnbc-metastatic/"}],"technology":[{"id":"adc","kind":"technology","name":"Antibody-drug conjugate (ADC)","route":"/technologies/adc/"}],"drug":[{"id":"sacituzumab-govitecan","kind":"drug","name":"Sacituzumab govitecan","route":"/drugs/sacituzumab-govitecan/"}],"term":[{"id":"tnbc-trials-open-today","kind":"term","name":"Triple-negative breast cancer trials open today (registry snapshot and UK sites)","route":"/terms/tnbc-trials-open-today/"}]}}