{"preliminary_commentary":{"by_channel":{"youtube":10,"podcast":9,"x_thread":8},"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":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT03197935\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's free public preview; the full report is still bought."},"name":"IMpassion 031","nct_id":"NCT03197935","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=impassion-031-nct03197935. The price is an estimate of verified HCP 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":1950,"size":"deep","size_rule":"Deep: 301+ verified HCP statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":"IMpassion031","arms":[{"description":"Participants received atezolizumab (840 milligrams \\[mg\\]) via intravenous (IV) infusion every 2 weeks in combination with nab-paclitaxel (125 milligrams per square meter \\[mg/m\\^2\\]) via IV infusion every week for 12 weeks, followed by atezolizumab (840 mg) every 2 weeks in combination with doxorubicin (60 mg/m\\^2) and cyclophosphamide (600 mg/m\\^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants continued to receive unblinded atezolizumab post-surgery at a fixed dose of 1200 mg by IV infusion every 3 weeks for 11 doses, for a total of approximately 12 months of atezolizumab therapy.","label":"Atezolizumab and Chemotherapy","type":"EXPERIMENTAL"},{"description":"Participants received placebo matched to atezolizumab via IV infusion every 2 weeks in combination with nab-paclitaxel (125 mg/m\\^2) via IV infusion every week for 12 weeks, followed by placebo matched to atezolizumab every 2 weeks in combination with doxorubicin (60 mg/m\\^2) and cyclophosphamide (600 mg/m\\^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants will be unblinded post-surgery and will continue to be followed.","label":"Placebo and Chemotherapy","type":"PLACEBO_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2022-09-28","type":"ACTUAL"},"conditions":["Triple-negative Breast Cancer"],"enrollment":{"count":333,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody","otherNames":[],"type":"DRUG"},{"name":"Placebo","otherNames":[],"type":"DRUG"},{"name":"Nab-paclitaxel","otherNames":[],"type":"DRUG"},{"name":"Doxorubicin","otherNames":[],"type":"DRUG"},{"name":"Cyclophosphamide","otherNames":[],"type":"DRUG"},{"name":"Filgrastim","otherNames":[],"type":"DRUG"},{"name":"Pegfilgrastim","otherNames":[],"type":"DRUG"}],"last_update":"2023-10-26","lead_sponsor":"Hoffmann-La Roche","official_title":"A Phase III Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Neoadjuvant Anthracycline/Nab-Paclitaxel-Based Chemotherapy Compared With Placebo and Chemotherapy in Patients With Primary Invasive Triple-Negative Breast Cancer","overall_status":"COMPLETED","phases":["PHASE3"],"primary_completion_date":{"date":"2020-04-03","type":"ACTUAL"},"primary_outcomes":[{"measure":"Number of Participants With Pathologic Complete Response (pCR) Using American Joint Committee on Cancer (AJCC) Staging System in ITT Population","timeFrame":"After neoadjuvant study treatment and surgery, up to primary analysis data cut off on 03 ApriI 2020"},{"measure":"Number of Participants With pCR in Subpopulation With PD-L1-Positive Tumor Status (Tumor-infiltrating Immune Cell [IC] 1/2/3) Using AJCC Staging System","timeFrame":"After neoadjuvant study treatment and surgery, up to primary analysis data cut off on 03 ApriI 2020"}],"references":[{"citation":"Mittendorf EA, Assaf ZJ, Harbeck N, Zhang H, Saji S, Jung KH, Hegg R, Koehler A, Sohn J, Iwata H, Telli ML, Ferrario C, Punie K, Qamra A, Dieterich M, Xu Y, Liste-Hermoso M, Shearer-Kang E, Molinero L, Chui SY, Barrios CH. Peri-operative atezolizumab in early-stage triple-negative breast cancer: final results and ctDNA analyses from the randomized phase 3 IMpassion031 trial. Nat Med. 2025 Jul;31(7):2397-2404. doi: 10.1038/s41591-025-03725-4. Epub 2025 Jun 4.","pmid":"40467898","type":"DERIVED"},{"citation":"Mittendorf EA, Zhang H, Barrios CH, Saji S, Jung KH, Hegg R, Koehler A, Sohn J, Iwata H, Telli ML, Ferrario C, Punie K, Penault-Llorca F, Patel S, Duc AN, Liste-Hermoso M, Maiya V, Molinero L, Chui SY, Harbeck N. Neoadjuvant atezolizumab in combination with sequential nab-paclitaxel and anthracycline-based chemotherapy versus placebo and chemotherapy in patients with early-stage triple-negative breast cancer (IMpassion031): a randomised, double-blind, phase 3 trial. Lancet. 2020 Oct 10;396(10257):1090-1100. doi: 10.1016/S0140-6736(20)31953-X. Epub 2020 Sep 20.","pmid":"32966830","type":"DERIVED"},{"citation":"Perez-Garcia J, Soberino J, Racca F, Gion M, Stradella A, Cortes J. Atezolizumab in the treatment of metastatic triple-negative breast cancer. Expert Opin Biol Ther. 2020 Sep;20(9):981-989. doi: 10.1080/14712598.2020.1769063. Epub 2020 May 25.","pmid":"32450725","type":"DERIVED"}],"start_date":{"date":"2017-07-24","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study to Investigate Atezolizumab and Chemotherapy Compared With Placebo and Chemotherapy in the Neoadjuvant Setting in Participants With Early Stage Triple Negative Breast Cancer","url":"https://clinicaltrials.gov/study/NCT03197935"},"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/impassion-031-nct03197935"}