{"commentary":{"count":26,"free_build_floor":8,"listing_floor":3,"by_channel":{"youtube":9,"podcast":9,"x_thread":8},"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\": \"NCT03056755\", \"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":"BYLieve","nct_id":"NCT03056755","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=bylieve-nct03056755. 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":1250,"size":"standard","size_rule":"Standard: 13–40 commentary sources"},"registry":{"acronym":"BYLieve","arms":[{"description":"Participants who received any Cyclin-Dependent Kinases 4 and 6 inhibitor (CDK 4/6i) plus aromatase inhibitor (AI) as immediate prior treatment will receive alpelisib + fulvestrant","label":"Cohort A: Pre-treated with CDK 4/6i + AI","type":"EXPERIMENTAL"},{"description":"Patients who received any CDK 4/6i plus fulvestrant as immediate prior treatment will receive alpelisib + letrozole","label":"Cohort B: Pre-treated with CDK 4/6i + fulvestrant","type":"EXPERIMENTAL"},{"description":"Participants who received systemic chemotherapy or endocrine therapy (ET) (as monotherapy or in combination with targeted treatment except CDK 4/6i + AI) as immediate prior treatment will receive alpelisib + fulvestrant.","label":"Cohort C: Pre-treated with systemic chemotherapy or ET","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2024-11-12","type":"ACTUAL"},"conditions":["Breast Cancer"],"enrollment":{"count":383,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Alpelisib","type":"DRUG"},{"name":"Fulvestrant","type":"DRUG"},{"name":"Letrozole","type":"DRUG"},{"name":"Goserelin","type":"DRUG"},{"name":"Leuprolide","type":"DRUG"}],"last_update":"2026-01-13","lead_sponsor":"Novartis Pharmaceuticals","official_title":"BYLieve: A Phase II, Multicenter, Open-label, Three-cohort, Non- Comparative Study to Assess the Efficacy and Safety of Alpelisib Plus Fulvestrant or Letrozole in Patients With PIK3CA Mutant, Hormone Receptor (HR) Positive, HER2-negative Advanced Breast Cancer (aBC), Who Have Progressed on or After Prior Treatments","overall_status":"COMPLETED","phases":["PHASE2"],"primary_completion_date":{"date":"2021-06-14","type":"ACTUAL"},"primary_outcomes":[{"measure":"Core Phase: Percentage of Participants Who Were Alive Without Disease Progression at 6 Months","timeFrame":"At 6 months"}],"references":[{"citation":"Rugo HS, Lerebours F, Ciruelos E, Drullinsky P, Ruiz-Borrego M, Neven P, Park YH, Prat A, Bachelot T, Juric D, Turner N, Sophos N, Zarate JP, Arce C, Shen YM, Turner S, Kanakamedala H, Hsu WC, Chia S. Alpelisib plus fulvestrant in PIK3CA-mutated, hormone receptor-positive advanced breast cancer after a CDK4/6 inhibitor (BYLieve): one cohort of a phase 2, multicentre, open-label, non-comparative study. Lancet Oncol. 2024 Dec;25(12):e629-e638. doi: 10.1016/S1470-2045(24)00673-9.","pmid":"39637900","type":"DERIVED"},{"citation":"Borrego MR, Lu YS, Reyes-Cosmelli F, Park YH, Yamashita T, Chiu J, Airoldi M, Turner N, Fein L, Ghaznawi F, Singh J, Pantoja K, Schnell C, Akdere M, Chia S. SGLT2 inhibition improves PI3Kalpha inhibitor-induced hyperglycemia: findings from preclinical animal models and from patients in the BYLieve and SOLAR-1 trials. Breast Cancer Res Treat. 2024 Nov;208(1):111-121. doi: 10.1007/s10549-024-07405-8. Epub 2024 Aug 23.","pmid":"39177931","type":"DERIVED"},{"citation":"Rodon J, Demanse D, Rugo HS, Burris HA, Simo R, Farooki A, Wellons MF, Andre F, Hu H, Vuina D, Quadt C, Juric D. A risk analysis of alpelisib-induced hyperglycemia in patients with advanced solid tumors and breast cancer. Breast Cancer Res. 2024 Mar 4;26(1):36. doi: 10.1186/s13058-024-01773-1.","pmid":"38439079","type":"DERIVED"},{"citation":"Rugo HS, Lerebours F, Ciruelos E, Drullinsky P, Ruiz-Borrego M, Neven P, Park YH, Prat A, Bachelot T, Juric D, Turner N, Sophos N, Zarate JP, Arce C, Shen YM, Turner S, Kanakamedala H, Hsu WC, Chia S. Alpelisib plus fulvestrant in PIK3CA-mutated, hormone receptor-positive advanced breast cancer after a CDK4/6 inhibitor (BYLieve): one cohort of a phase 2, multicentre, open-label, non-comparative study. Lancet Oncol. 2021 Apr;22(4):489-498. doi: 10.1016/S1470-2045(21)00034-6.","pmid":"33794206","type":"DERIVED"}],"start_date":{"date":"2017-08-29","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant or Letrozole, Based on Prior Endocrine Therapy, in Patients With PIK3CA Mutant, HR+, HER2- Advanced Breast Cancer Who Have Progressed on or After Prior Treatments","url":"https://clinicaltrials.gov/study/NCT03056755"},"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/bylieve-nct03056755"}