{"commentary":{"count":179,"free_build_floor":8,"listing_floor":3,"by_channel":{"podcast":62,"youtube":59,"x_thread":58},"note":"Indexed podcasts, YouTube videos and X posts that name this trial. A report screens them, searches for more and cites what clinicians said when it is built."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT03901339\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's public preview; the full report is still bought."},"name":"TROPiCS-02","nct_id":"NCT03901339","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=tropics-02-nct03901339. The price is fixed at order. We build the report after the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":1950,"size":"deep","size_rule":"Deep: 41+ commentary sources"},"registry":{"acronym":"TROPiCS-02","arms":[{"description":"Participants will receive sacituzumab govitecan-hziy 10 mg/kg via intravenous (IV) injection administered on Day 1 and Day 8 of a 21-day cycle.","label":"Sacituzumab Govitecan-hziy","type":"EXPERIMENTAL"},{"description":"Participants will receive TPC determined prior to randomization from one of the following single-agent treatment:\n\nDosing per National Comprehensive Cancer Network (NCCN) guidelines (with dose modifications for if toxic)\n\n* Eribulin: 1.4 mg/m\\^2 for North American sites, 1.23 mg/m\\^2 for European sites) via IV on Days 1 and 8 of a 21-day cycle\n* Capecitabine: 1000-1250 mg/m\\^2 orally twice daily for 2 weeks followed by a 1-week rest period given as a 21-day cycle\n* Gemcitabine: 800-1200 mg/m\\^2 via IV on Days 1, 8, and 15 of each 28-day cycle or per institution\n* Vinorelbine: 25 mg/m\\^2 via IV on Day 1 weekly cycle per institution","label":"Treatment of Physician's Choice (TPC)","type":"ACTIVE_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2023-10-20","type":"ACTUAL"},"conditions":["Metastatic Breast Cancer"],"enrollment":{"count":543,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Sacituzumab Govitecan-hziy","type":"DRUG"},{"name":"Eribulin","type":"DRUG"},{"name":"Capecitabine","type":"DRUG"},{"name":"Gemcitabine","type":"DRUG"},{"name":"Vinorelbine","type":"DRUG"}],"last_update":"2024-10-21","lead_sponsor":"Gilead Sciences","official_title":"Phase 3 Study of Sacituzumab Govitecan (IMMU-132) Versus Treatment of Physician's Choice (TPC) in Subjects With Hormonal Receptor-Positive (HR+) Human Epidermal Growth Factor Receptor 2 (HER2) Negative Metastatic Breast Cancer (MBC) Who Have Failed at Least Two Prior Chemotherapy Regimens","overall_status":"COMPLETED","phases":["PHASE3"],"primary_completion_date":{"date":"2023-10-20","type":"ACTUAL"},"primary_outcomes":[{"measure":"Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) Assessment","timeFrame":"Up to 42.8 months"}],"references":[{"citation":"Rugo HS, Bardia A, Marme F, Cortes J, Schmid P, Loirat D, Tredan O, Ciruelos E, Dalenc F, Gomez Pardo P, Jhaveri KL, Delaney R, Valdez T, Wang H, Motwani M, Yoon OK, Verret W, Tolaney SM. 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. Lancet. 2023 Oct 21;402(10411):1423-1433. doi: 10.1016/S0140-6736(23)01245-X. Epub 2023 Aug 23.","pmid":"37633306","type":"BACKGROUND"},{"citation":"Rugo HS, Bardia A, Marme F, Cortes J, Schmid P, Loirat D, Tredan O, Ciruelos E, Dalenc F, Pardo PG, Jhaveri KL, Delaney R, Fu O, Lin L, Verret W, Tolaney SM. Sacituzumab Govitecan in Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Metastatic Breast Cancer. J Clin Oncol. 2022 Oct 10;40(29):3365-3376. doi: 10.1200/JCO.22.01002. Epub 2022 Aug 26.","pmid":"36027558","type":"BACKGROUND"},{"citation":"Rugo HS, Bardia A, Tolaney SM, Arteaga C, Cortes J, Sohn J, Marme F, Hong Q, Delaney RJ, Hafeez A, Andre F, Schmid P. TROPiCS-02: A Phase III study investigating sacituzumab govitecan in the treatment of HR+/HER2- metastatic breast cancer. Future Oncol. 2020 Apr;16(12):705-715. doi: 10.2217/fon-2020-0163. Epub 2020 Mar 30.","pmid":"32223649","type":"BACKGROUND"},{"citation":"Rugo HS, Schmid P, Tolaney SM, Dalenc F, Marme F, Shi L, Verret W, Shah A, Gharaibeh M, Bardia A, Cortes J. Health-related quality of life with sacituzumab govitecan in HR+/HER2- metastatic breast cancer in the phase III TROPiCS-02 trial. Oncologist. 2024 Sep 6;29(9):768-779. doi: 10.1093/oncolo/oyae088.","pmid":"38748596","type":"BACKGROUND"},{"citation":"Rugo HS, Bardia A, Marme F, Cortes J, Schmid P, Spears PA, Tolaney SM. A plain language summary of the TROPiCS-02 study in patients with breast cancer (HR-positive/HER2-negative). Future Oncol. 2024 Apr;20(11):635-651. doi: 10.2217/fon-2023-0845. Epub 2024 Jan 25.","pmid":"38270051","type":"BACKGROUND"},{"citation":"Rugo HS, Bardia A, Tolaney S. Sacituzumab govitecan for metastatic breast cancer: the TROPiCS-02 trial - Authors' reply. Lancet. 2024 Jul 27;404(10450):339-340. doi: 10.1016/S0140-6736(24)01049-3. No abstract available.","pmid":"39067902","type":"BACKGROUND"},{"citation":"Sathe AG, Jones AK, Diderichsen PM, Wang X, Chang P, Verret W, Girish S. Sacituzumab Govitecan Population Pharmacokinetics: Updated Analyses Using HR+/HER2- Metastatic Breast Cancer Data From the Phase 3 TROPiCS-02 Trial. Clin Transl Sci. 2025 Jul;18(7):e70291. doi: 10.1111/cts.70291.","pmid":"40657894","type":"DERIVED"},{"citation":"McCann KE, Hurvitz SA. Innovations in targeted therapies for triple negative breast cancer. Curr Opin Obstet Gynecol. 2021 Feb 1;33(1):34-47. doi: 10.1097/GCO.0000000000000671.","pmid":"33093337","type":"DERIVED"},{"citation":"Kalinsky K, Diamond JR, Vahdat LT, Tolaney SM, Juric D, O'Shaughnessy J, Moroose RL, Mayer IA, Abramson VG, Goldenberg DM, Sharkey RM, Maliakal P, Hong Q, Goswami T, Wegener WA, Bardia A. Sacituzumab govitecan in previously treated hormone receptor-positive/HER2-negative metastatic breast cancer: final results from a phase I/II, single-arm, basket trial. Ann Oncol. 2020 Dec;31(12):1709-1718. doi: 10.1016/j.annonc.2020.09.004. Epub 2020 Sep 15.","pmid":"32946924","type":"DERIVED"}],"start_date":{"date":"2019-05-08","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice in Participants With HR+/HER2- Metastatic Breast Cancer","url":"https://clinicaltrials.gov/study/NCT03901339"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"2.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/tropics-02-nct03901339"}