{"entity":{"id":"tropics-02","kind":"trial","name":"TROPiCS-02","aka":[],"tldr":"The TROP2 ADC extended survival by about three months in heavily pretreated hormone-positive breast cancer.","summary":"TROPiCS-02, trial NCT03901339 sponsored by Gilead and reported in 2022, showed that the TROP2 antibody-drug conjugate sacituzumab govitecan extends survival in heavily pretreated HR-positive, HER2-negative metastatic breast cancer. It randomised 543 women who had received endocrine therapy, a CDK4/6 inhibitor and two to four chemotherapies to sacituzumab govitecan or chemotherapy, met its primary progression-free survival endpoint and showed an overall survival benefit of a few months, leading to approval in February 2023 and establishing antibody-drug conjugates in this disease after chemotherapy. OnCo links it to TROP2 as a target, sacituzumab govitecan and Hope S. Rugo. Whether TROP2 ADCs should move earlier, before chemotherapy, is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03901339","url":"https://clinicaltrials.gov/study/NCT03901339"}],"tags":[],"related":[],"cancers":["breast-hr-positive","hr-positive-metastatic-post-cdk46"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":["trop2"],"drugs":["sacituzumab-govitecan"],"companies":["gilead"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["hope-rugo"],"bottlenecks":[],"keyPapers":["paper-tropics-02-lancet-2023"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03901339","phase":"3","setting":"HR+/HER2- metastatic breast cancer after endocrine therapy, CDK4/6, and 2-4 chemotherapies: sacituzumab govitecan vs chemotherapy","sponsor":"Gilead","result":"OS 14.4 vs 11.2 months, HR 0.79.","started":"2019-05-08","startedType":"actual","yearReported":2022,"enrolled":543,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"Sacituzumab govitecan","n":272,"value":5.5},{"name":"Chemotherapy","n":271,"value":4}],"hr":0.66,"ci":[0.53,0.83],"p":"0.0003","source":"https://ascopubs.org/doi/10.1200/JCO.22.01002"},{"endpoint":"Overall survival","unit":"months","arms":[{"name":"Sacituzumab govitecan","value":14.4},{"name":"Chemotherapy","value":11.2}],"hr":0.79,"ci":[0.65,0.96],"p":"0.02","source":"https://doi.org/10.1200/JCO.22.01002"}],"replication":"TROPION-Breast01 (Dato-DXd) replicated the PFS effect of a TROP2 ADC in this population but not OS."},"route":"/trials/tropics-02/","neighbours":{"cancer":[{"id":"breast-hr-positive","kind":"cancer","name":"HR-positive / HER2-negative breast cancer","route":"/cancers/breast-hr-positive/"},{"id":"hr-positive-metastatic-post-cdk46","kind":"cancer","name":"HR-positive metastatic breast cancer after CDK4/6 inhibitors","route":"/cancers/hr-positive-metastatic-post-cdk46/"}],"technology":[{"id":"adc","kind":"technology","name":"Antibody-drug conjugate (ADC)","route":"/technologies/adc/"},{"id":"topoisomerase-inhibitors","kind":"technology","name":"Topoisomerase-I inhibitors (and ADC payloads)","route":"/technologies/topoisomerase-inhibitors/"}],"target":[{"id":"trop2","kind":"target","name":"TROP2","route":"/targets/trop2/"}],"drug":[{"id":"sacituzumab-govitecan","kind":"drug","name":"Sacituzumab govitecan","route":"/drugs/sacituzumab-govitecan/"}],"company":[{"id":"gilead","kind":"company","name":"Gilead Sciences (incl. Kite)","route":"/companies/gilead/"}],"person":[{"id":"hope-rugo","kind":"person","name":"Hope S. Rugo","route":"/people/hope-rugo/"}],"paper":[{"id":"paper-tropics-02-lancet-2023","kind":"paper","name":"Overall survival with sacituzumab govitecan in hormone receptor-positive and human epidermal growth factor receptor 2-negative metastatic breast cancer (TROPiCS-02): a randomised, open-label, multicentre, phase 3 trial","route":"/key-papers/paper-tropics-02-lancet-2023/"}]}}