{"commentary":{"count":68,"free_build_floor":8,"listing_floor":3,"by_channel":{"x_thread":50,"youtube":11,"podcast":7},"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\": \"NCT01358877\", \"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":"APHINITY","nct_id":"NCT01358877","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=aphinity-nct01358877. 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":"APHINITY","arms":[{"description":"Participants will receive pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) intravenously (IV) every 3 weeks (Q3W) for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\\^2 + epirubicin 90-120 mg/m\\^2 or doxorubicin 50 mg/m\\^2 + cyclophosphamide 500-600 mg/m\\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\\^2 for 3 cycles, 75 mg/m\\^2 in first cycle and 100 mg/m\\^2 in subsequent cycles, or 75 mg/m\\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\\^2 once weekly (QW); 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\\^2 or epirubicin 90-120 mg/m\\^2 + cyclophosphamide 500-600 mg/m\\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\\^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).","label":"Pertuzumab + Trastuzumab + Chemotherapy","type":"EXPERIMENTAL"},{"description":"Participants will receive placebo matching to pertuzumab IV Q3W and trastuzumab (8 milligrams per kilogram \\[mg/kg\\] loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 milligrams per square meter (mg/m\\^2) + epirubicin 90-120 mg/m\\^2 or doxorubicin 50 mg/m\\^2 + cyclophosphamide 500-600 mg/m\\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\\^2 for 3 cycles, 75 mg/m\\^2 in first cycle and 100 mg/m\\^2 in subsequent cycles, or 75 mg/m\\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\\^2 or epirubicin 90-120 mg/m\\^2 + cyclophosphamide 500-600 mg/m\\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\\^2 + carboplatin AUC 6 (up to 900 milligrams \\[mg\\]).","label":"Placebo + Trastuzumab + Chemotherapy","type":"PLACEBO_COMPARATOR"}],"collaborators":["Genentech, Inc.","Breast International Group"],"completion_date":{"date":"2024-11-28","type":"ACTUAL"},"conditions":["Breast Cancer"],"enrollment":{"count":4804,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"5-Fluorouracil","type":"DRUG"},{"name":"Carboplatin","type":"DRUG"},{"name":"Cyclophosphamide","type":"DRUG"},{"name":"Docetaxel","type":"DRUG"},{"name":"Doxorubicin","type":"DRUG"},{"name":"Epirubicin","type":"DRUG"},{"name":"Paclitaxel","type":"DRUG"},{"name":"Pertuzumab","type":"DRUG"},{"name":"Placebo","type":"DRUG"},{"name":"Trastuzumab","type":"DRUG"}],"last_update":"2025-11-28","lead_sponsor":"Hoffmann-La Roche","official_title":"A Randomized Multicenter, Double-Blind, Placebo-Controlled Comparison of Chemotherapy Plus Trastuzumab Plus Placebo Versus Chemotherapy Plus Trastuzumab Plus Pertuzumab as Adjuvant Therapy in Patients With Operable HER2-Positive Primary Breast Cancer","overall_status":"COMPLETED","phases":["PHASE3"],"primary_completion_date":{"date":"2016-12-19","type":"ACTUAL"},"primary_outcomes":[{"measure":"Percentage of Participants With Invasive Disease-Free Survival (IDFS) Event (Excluding Second Primary Non-Breast Cancer [SPNBC]), as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings","timeFrame":"Randomization to the first occurrence of IDFS event (excluding SPNBC) (until data cut-off date 19 December 2016; median [range] follow-up: 3.8 [0-4.9] years)"},{"measure":"Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Excluding SPNBC) at 3 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings","timeFrame":"3 years"}],"references":[{"citation":"Agostinetto E, Gentile G, Samy F, Di Cosimo S, Aftimos P, Ponde N, Eiger D, Lambertini M, Cameron D, Kiermaier A, Bailey A, Viale G, Loi S, Piccart M, de Azambuja E. The benefit of adjuvant pertuzumab and trastuzumab according to estrogen receptor and HER2 expression: a subanalysis of the APHINITY trial. J Natl Cancer Inst. 2026 Aug 1;118(8):1504-1513. doi: 10.1093/jnci/djag095.","pmid":"41934626","type":"DERIVED"},{"citation":"Loibl S, Jassem J, Sonnenblick A, Parlier D, Winer E, Bergh J, Gelber RD, Restuccia E, Im YH, Huang CS, Dalenc F, Calvo I, Procter M, Caballero C, Clark E, Raimbault A, McConnell R, Monturus E, de Azambuja E, Gomez HL, Bliss J, Viale G, Bines J, Piccart M; APHINITY Steering Committee and Investigators. Adjuvant Pertuzumab and Trastuzumab in Early Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer in the APHINITY Trial: Third Interim Overall Survival Analysis With Efficacy Update. J Clin Oncol. 2024 Nov;42(31):3643-3651. doi: 10.1200/JCO.23.02505. Epub 2024 Sep 11.","pmid":"39259927","type":"DERIVED"},{"citation":"de Azambuja E, Agostinetto E, Procter M, Eiger D, Ponde N, Guillaume S, Parlier D, Lambertini M, Desmet A, Caballero C, Aguila C, Jerusalem G, Walshe JM, Frank E, Bines J, Loibl S, Piccart-Gebhart M, Ewer MS, Dent S, Plummer C, Suter T; APHINITY Steering Committee and Investigators. Cardiac safety of dual anti-HER2 blockade with pertuzumab plus trastuzumab in early HER2-positive breast cancer in the APHINITY trial. ESMO Open. 2023 Feb;8(1):100772. doi: 10.1016/j.esmoop.2022.100772. Epub 2023 Jan 19.","pmid":"36681013","type":"DERIVED"},{"citation":"Lambertini M, Fielding S, Loibl S, Janni W, Clark E, Franzoi MA, Fumagalli D, Caballero C, Arecco L, Salomoni S, Ponde NF, Poggio F, Kim HJ, Villarreal-Garza C, Pagani O, Paluch-Shimon S, Ballestrero A, Del Mastro L, Piccart M, Bines J, Partridge AH, de Azambuja E. Impact of Age on Clinical Outcomes and Efficacy of Adjuvant Dual Anti-HER2 Targeted Therapy. J Natl Cancer Inst. 2022 Aug 8;114(8):1117-1126. doi: 10.1093/jnci/djac096.","pmid":"35512402","type":"DERIVED"},{"citation":"Gelber RD, Wang XV, Cole BF, Cameron D, Cardoso F, Tjan-Heijnen V, Krop I, Loi S, Salgado R, Kiermaier A, Frank E, Fumagalli D, Caballero C, de Azambuja E, Procter M, Clark E, Restuccia E, Heeson S, Bines J, Loibl S, Piccart-Gebhart M; APHINITY Steering Committee and Investigators. Six-year absolute invasive disease-free survival benefit of adding adjuvant pertuzumab to trastuzumab and chemotherapy for patients with early HER2-positive breast cancer: A Subpopulation Treatment Effect Pattern Plot (STEPP) analysis of the APHINITY (BIG 4-11) trial. Eur J Cancer. 2022 May;166:219-228. doi: 10.1016/j.ejca.2022.01.031. Epub 2022 Mar 18.","pmid":"35313167","type":"DERIVED"},{"citation":"Bines J, Clark E, Barton C, Restuccia E, Procter M, Sonnenblick A, Fumagalli D, Parlier D, Arahmani A, Baselga J, Viale G, Reaby LL, Frank E, Gelber RD, Piccart M, Jackisch C, Petersen JA. Patient-reported function, health-related quality of life, and symptoms in APHINITY: pertuzumab plus trastuzumab and chemotherapy in HER2-positive early breast cancer. Br J Cancer. 2021 Jul;125(1):38-47. doi: 10.1038/s41416-021-01323-y. Epub 2021 Apr 7.","pmid":"33828257","type":"DERIVED"},{"citation":"Piccart M, Procter M, Fumagalli D, de Azambuja E, Clark E, Ewer MS, Restuccia E, Jerusalem G, Dent S, Reaby L, Bonnefoi H, Krop I, Liu TW, Pienkowski T, Toi M, Wilcken N, Andersson M, Im YH, Tseng LM, Lueck HJ, Colleoni M, Monturus E, Sicoe M, Guillaume S, Bines J, Gelber RD, Viale G, Thomssen C; APHINITY Steering Committee and Investigators. Adjuvant Pertuzumab and Trastuzumab in Early HER2-Positive Breast Cancer in the APHINITY Trial: 6 Years' Follow-Up. J Clin Oncol. 2021 May 1;39(13):1448-1457. doi: 10.1200/JCO.20.01204. Epub 2021 Feb 4.","pmid":"33539215","type":"DERIVED"},{"citation":"Bines J, Procter M, Restuccia E, Viale G, Zardavas D, Suter T, Arahmani A, Van Dooren V, Baselga J, Clark E, Eng-Wong J, Gelber RD, Piccart M, Mobus V, de Azambuja E; APHINITY Steering Committee and Investigators. Incidence and Management of Diarrhea With Adjuvant Pertuzumab and Trastuzumab in Patients With Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer. Clin Breast Cancer. 2020 Apr;20(2):174-181.e3. doi: 10.1016/j.clbc.2019.06.016. Epub 2019 Sep 5.","pmid":"31924513","type":"DERIVED"},{"citation":"Luo Y, Li W, Jiang Z, Zhang Q, Wang L, Mao Y, Tjan-Heijnen VCG, Im SA, McConnell R, Bejarano S, Fumagalli D, Bines J, Wang B, Garg A, Kirschbrown WP, Xu B. Pharmacokinetics of pertuzumab administered concurrently with trastuzumab in Chinese patients with HER2-positive early breast cancer. Anticancer Drugs. 2019 Sep;30(8):866-872. doi: 10.1097/CAD.0000000000000808.","pmid":"31305270","type":"DERIVED"},{"citation":"Kirschbrown WP, Kagedal M, Wang B, Lindbom L, Knott A, Mack R, Monemi S, Nijem I, Girish S, Freeman C, Fumagalli D, McConnell R, Jerusalem G, Twelves C, Baselga J, von Minckwitz G, Bines J, Garg A. Pharmacokinetic and exploratory exposure-response analysis of pertuzumab in patients with operable HER2-positive early breast cancer in the APHINITY study. Cancer Chemother Pharmacol. 2019 Jun;83(6):1147-1158. doi: 10.1007/s00280-019-03826-1. Epub 2019 Apr 11.","pmid":"30976844","type":"DERIVED"},{"citation":"von Minckwitz G, Procter M, de Azambuja E, Zardavas D, Benyunes M, Viale G, Suter T, Arahmani A, Rouchet N, Clark E, Knott A, Lang I, Levy C, Yardley DA, Bines J, Gelber RD, Piccart M, Baselga J; APHINITY Steering Committee and Investigators. Adjuvant Pertuzumab and Trastuzumab in Early HER2-Positive Breast Cancer. N Engl J Med. 2017 Jul 13;377(2):122-131. doi: 10.1056/NEJMoa1703643. Epub 2017 Jun 5.","pmid":"28581356","type":"DERIVED"}],"start_date":{"date":"2011-11-08","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study of Pertuzumab in Addition to Chemotherapy and Trastuzumab as Adjuvant Therapy in Participants With Human Epidermal Growth Receptor 2 (HER2)-Positive Primary Breast Cancer","url":"https://clinicaltrials.gov/study/NCT01358877"},"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/aphinity-nct01358877"}