{"preliminary_commentary":{"by_channel":{"x_thread":4},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":false},"commentary_summary":null,"drugs_tested":[["ipatasertib"]],"indication":"PIK3CA/AKT1/PTEN-altered advanced HER2-negative breast cancer","name":"IPATunity130","nct_id":"NCT03337724","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=ipatunity130-nct03337724. The price is an estimate of verified statements from the commentary indexed so far. Final coverage is set when the report is built. You never pay more than quoted: if the report is delivered at a smaller size, you pay that size's price, and anything paid above it is refunded. 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_rule":"Never more than quoted: the buyer pays the smaller of price_usd and the price the delivered edition is sold at.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":"IPATunity130","arms":[{"description":null,"label":"Ipatasertib + Paclitaxel","type":"EXPERIMENTAL"},{"description":null,"label":"Placebo + Paclitaxel","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2023-01-04","type":"ACTUAL"},"conditions":["Breast Cancer"],"enrollment":{"count":579,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Ipatasertib","otherNames":[],"type":"DRUG"},{"name":"Paclitaxel","otherNames":[],"type":"DRUG"},{"name":"Placebo","otherNames":[],"type":"DRUG"}],"last_update":"2024-03-12","lead_sponsor":"Hoffmann-La Roche","official_title":"A Double-Blind, Placebo-Controlled, Randomized Phase III Study of Ipatasertib in Combination With Paclitaxel as a Treatment for Patients With PIK3CA/AKT1/PTEN-Altered, Locally Advanced or Metastatic, Triple-Negative Breast Cancer or Hormone Receptor-Positive, HER2-Negative Breast Cancer","overall_status":"COMPLETED","phases":["PHASE3"],"primary_completion_date":{"date":"2023-01-04","type":"ACTUAL"},"primary_outcomes":[{"measure":"Cohort A: Progression-Free Survival (PFS)","timeFrame":"From randomization up to 27 months"},{"measure":"Cohort B: PFS","timeFrame":"From randomization up to 24.4 months"},{"measure":"Cohort C: PFS","timeFrame":"From enrollment up to 31 months"}],"references":[{"citation":"Turner N, Dent RA, O'Shaughnessy J, Kim SB, Isakoff SJ, Barrios C, Saji S, Bondarenko I, Nowecki Z, Lian Q, Reilly SJ, Hinton H, Wongchenko MJ, Kovic B, Mani A, Oliveira M. Ipatasertib plus paclitaxel for PIK3CA/AKT1/PTEN-altered hormone receptor-positive HER2-negative advanced breast cancer: primary results from cohort B of the IPATunity130 randomized phase 3 trial. Breast Cancer Res Treat. 2022 Feb;191(3):565-576. doi: 10.1007/s10549-021-06450-x. Epub 2021 Dec 3.","pmid":"34860318","type":"DERIVED"}],"start_date":{"date":"2018-01-06","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study of Ipatasertib in Combination With Paclitaxel as a Treatment for Participants With PIK3CA/AKT1/PTEN-Altered, Locally Advanced or Metastatic, Triple-Negative Breast Cancer or Hormone Receptor-Positive, HER2-Negative Breast Cancer","url":"https://clinicaltrials.gov/study/NCT03337724"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.2","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/ipatunity130-nct03337724"}