{"commentary":{"count":122,"free_build_floor":8,"listing_floor":3,"by_channel":{"youtube":58,"podcast":36,"x_thread":28},"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\": \"NCT03079011\", \"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":"PADA-1","nct_id":"NCT03079011","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=pada-1-nct03079011. 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":"PADA-1","arms":[{"description":"After randomization, the patient will be treated with palbociclib 125 mg once daily for 21 days followed by 7 days off to complete a 28-day cycle in combination with an aromatase inhibitor (letrozole, anastrozole or exemestane, according to physician's choice and according their respective summary product characteristics) administered once daily in a continuous scheme.","label":"A- palbociclib + AI","type":"EXPERIMENTAL"},{"description":"After randomization, the patient will be treated with palbociclib 125 mg once daily for 21 days followed by 7 days off to complete a 28-day cycle in combination with fulvestrant, a selective estrogen receptor down-regulator, 500 mg administered intramuscularly on Days 1, 15, and 29 and once monthly thereafter.","label":"B- Palbociclib + fulvestrant","type":"EXPERIMENTAL"},{"description":"All patients included into the study will be treated with palbociclib 125 mg once daily for 21 days followed by 7 days off to complete a 28-day cycle in combination with an aromatase inhibitor (letrozole, anastrozole or exemestane, according to physician's choice and according their respective summary product characteristics) administered once daily in a continuous scheme","label":"Selection - Palbociclib + AI","type":"EXPERIMENTAL"}],"collaborators":["Pfizer"],"completion_date":{"date":"2025-09-22","type":"ACTUAL"},"conditions":["Metastatic Breast Cancer"],"enrollment":{"count":1017,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Palbociclib 125mg","type":"DRUG"},{"name":"Aromatase Inhibitors","type":"DRUG"},{"name":"Fulvestrant Injectable Product","type":"DRUG"}],"last_update":"2025-11-18","lead_sponsor":"UNICANCER","official_title":"Randomized, Open Label, Multicentric Phase III Trial to Evaluate the Safety and Efficacy of Palbociclib in Combination With HT Driven by ctDNA ESR1 Mutation Monitoring in ER+, HER2-negative Metastatic Breast Cancer Patients","overall_status":"COMPLETED","phases":["PHASE3"],"primary_completion_date":{"date":"2021-04-30","type":"ACTUAL"},"primary_outcomes":[{"measure":"Incidence of treatment-emergent Adverse Events","timeFrame":"Throughout study completion, up to 4 years"},{"measure":"Progression-free survival (Step 2)","timeFrame":"From randomization to disease progression or death, up to 4 years"}],"references":[{"citation":"Bidard FC, Hardy-Bessard AC, Dalenc F, Bachelot T, Pierga JY, de la Motte Rouge T, Sabatier R, Dubot C, Frenel JS, Ferrero JM, Ladoire S, Levy C, Mouret-Reynier MA, Lortholary A, Grenier J, Chakiba C, Stefani L, Plaza JE, Clatot F, Teixeira L, D'Hondt V, Vegas H, Derbel O, Garnier-Tixidre C, Canon JL, Pistilli B, Andre F, Arnould L, Pradines A, Bieche I, Callens C, Lemonnier J, Berger F, Delaloge S; PADA-1 investigators. Switch to fulvestrant and palbociclib versus no switch in advanced breast cancer with rising ESR1 mutation during aromatase inhibitor and palbociclib therapy (PADA-1): a randomised, open-label, multicentre, phase 3 trial. Lancet Oncol. 2022 Nov;23(11):1367-1377. doi: 10.1016/S1470-2045(22)00555-1. Epub 2022 Sep 29.","pmid":"36183733","type":"DERIVED"},{"citation":"Berger F, Marce M, Delaloge S, Hardy-Bessard AC, Bachelot T, Bieche I, Pradines A, De La Motte Rouge T, Canon JL, Andre F, Arnould L, Clatot F, Lemonnier J, Marques S, Bidard FC; PADA-1 investigators. Randomised, open-label, multicentric phase III trial to evaluate the safety and efficacy of palbociclib in combination with endocrine therapy, guided by ESR1 mutation monitoring in oestrogen receptor-positive, HER2-negative metastatic breast cancer patients: study design of PADA-1. BMJ Open. 2022 Mar 3;12(3):e055821. doi: 10.1136/bmjopen-2021-055821.","pmid":"35241469","type":"DERIVED"}],"start_date":{"date":"2017-03-22","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"PAlbociclib and Circulating Tumor DNA for ESR1 Mutation Detection","url":"https://clinicaltrials.gov/study/NCT03079011"},"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/pada-1-nct03079011"}