{"preliminary_commentary":{"by_channel":{"podcast":2,"bluesky_thread":1},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. A report screens them, searches for more and cites what clinicians said when it is built, so final coverage is set at build."},"free_build":{"available":false},"name":"CAPELA","nct_id":"NCT07222215","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=capela-nct07222215. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":"CAPELA","arms":[{"description":"Participants will be randomized 1:1, enrolled, and stratified based on the receipt of one or greater than one prior lines of endocrine therapy in the metastatic setting, presence or absence of visceral disease, presence or absence of ESR1 mutation, and presence or absence of p53 mutation.\n\n* Baseline visit with assessments\n* Imaging every 9 weeks for 27 weeks, then every 12 weeks\n* Cycle 1 through End of Treatment (21-day cycles):\n\n  * Days 1 - 14: Predetermined dose of Capecitabine 2x daily for 14 days followed by 7 days off\n  * Days 1 - 21: Predetermined dose of Elacestrant 1x daily\n* Follow up: every 6 months after end of treatment","label":"Arm A: Capecitabine + Elacestrant","type":"EXPERIMENTAL"},{"description":"Participants will be randomized 1:1, enrolled, and stratified based on the receipt of one or greater than one prior lines of endocrine therapy in the metastatic setting, presence or absence of visceral disease, presence or absence of ESR1 mutation, and presence or absence of p53 mutation.\n\n* Baseline visit with assessments\n* Imaging every 9 weeks for 27 weeks, then every 12 weeks\n* Cycle 1 through End of Treatment (21-day cycles):\n\n  --Days 1 - 14: Predetermined dose of Capecitabine 2x daily for 14 days followed by 7 days off\n* Follow up: every 6 months after end of treatment","label":"Arm B: Capecitabine Monotherapy","type":"EXPERIMENTAL"},{"description":"For Arm B participants with ESR1 mutation, at the time of progression on Capecitabine participants have the option to continue on trial and switch to single agent Elacestrant monotherapy.\n\n-Imaging every 9 weeks for 27 weeks, then every 12 weeks\n\nThrough End of Treatment (21-day cycles):\n\n--Days 1 - 21: Predetermined dose of Elacestrant 1x daily\n\n-Follow up: every 6 months after end of treatment","label":"Optional switch after progression on Arm B Capecitabine monotherapy: Elacestrant Monotherapy","type":"EXPERIMENTAL"}],"collaborators":["Stemline Therapeutics, Inc.","Johns Hopkins University","Translational Breast Cancer Research Consortium","Menarini Group","Gateway for Cancer Research","Terri Brodeur Breast Cancer Foundation"],"completion_date":{"date":"2030-10-01","type":"ESTIMATED"},"conditions":["Estrogen-receptor-positive Breast Cancer","Metastatic Breast Cancer","Breast Cancer","Hormone Receptor Positive Breast Cancer","Human Epidermal Growth Factor 2 Negative Carcinoma of Breast","HER2- Breast Cancer","ESR1 Gene Mutation","ER Wildtype","Breast Neoplasms"],"enrollment":{"count":297,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"Capecitabine","otherNames":["Xeloda"],"type":"DRUG"},{"name":"Elacestrant","otherNames":["RAD1901","Elacestrant Dihydrochloride","RAD1901 - 2 HCl","C30H40Cl2N2O2"],"type":"DRUG"}],"last_update":"2026-08-26","lead_sponsor":"Kristina A. Fanucci","official_title":"A Phase II Multi-Center Open-label Randomized Study of CAPecitabine in Combination With ELAcestrant Versus Capecitabine Alone in Advanced Estrogen Receptor-Positive Breast Cancer (CAPELA)","overall_status":"RECRUITING","phases":["PHASE2"],"primary_completion_date":{"date":"2029-12-01","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Progression Free Survival (PFS) in ESR1 mutant population","timeFrame":"Tumor measurements are repeated every 3 cycles (each cycle is 21 days) for the first 9 cycles. After cycle 9 tumor measurements will be performed every 4 cycles."},{"measure":"Progression Free Survival (PFS) in intention to treat (ITT) population","timeFrame":"Tumor measurements are repeated every 3 cycles (each cycle is 21 days) for the first 9 cycles. After cycle 9 tumor measurements will be performed every 4 cycles."}],"references":[],"start_date":{"date":"2026-01-16","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"PhII Randomized CAPecitabine + ELAcestrant vs. Capecitabine Alone in ER+ Breast Cancer (CAPELA)","url":"https://clinicaltrials.gov/study/NCT07222215"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/capela-nct07222215"}