{"commentary":{"count":60,"free_build_floor":8,"listing_floor":3,"by_channel":{"x_thread":48,"youtube":6,"podcast":4,"x_video":2},"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\": \"NCT03161353\", \"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":"PHERGain","nct_id":"NCT03161353","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=phergain-nct03161353. 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":"PHERGain","arms":[{"description":"Cohorts A/B if there is no evidence of subclinic M1 assessed by 18F-FDG PET/CT at screening. Interventional: Perjeta+Herceptin+Carboplatin+Docetaxel (during 4 cycles):\n\nPET responders or not responders after surgery: Continue with Perjeta+Herceptin+ Endocrine therapy (tamoxifen or letrozole) during 12 cycles\n\nA sub-set of 42 patients (35 patients from cohort A and 7 patients from cohort B) from 5 sites in Spain are participating in the LINGain sub-study \"Prospective evaluation of predictive/prognostic immunogenicity biomarkers for target therapy in HER2-positive early breast cancer within the PHERGain study\".","label":"Cohort A","type":"EXPERIMENTAL"},{"description":"Cohorts A/B if there is no evidence of subclinic M1 assessed by 18F-FDG PET/CT at screening. Interventional: Perjeta+Herceptin+Endocrine therapy (tamoxifen or letrozole) during 2 cycles.\n\n* PET responders: Perjeta+Herceptin+Endocrine therapy during 6 cycles. -Complete response: continue with Perjeta+Herceptin+ Endocrine therapy during 10 cycles -Non-complete response: Perjeta+Herceptin+ Carboplatin+ Docetaxel during 6 cycles and Perjeta+Herceptin+Endocrine therapy during 4 cycles.\n* PET non-responders: Perjeta+Herceptin+Carboplatin+Docetaxel during 6 cycles. Patients with or without complete response will continue with Perjeta+Herceptin+Endocrine therapy during 10 cycles.\n\nA sub-set of 42 patients (35 patients from cohort A and 7 patients from cohort B) from 5 sites in Spain are participating in the LINGain sub-study \"Prospective evaluation of predictive/prognostic immunogenicity biomarkers for target therapy in HER2-positive early breast cancer within the PHERGain study\".","label":"Cohort B","type":"EXPERIMENTAL"},{"description":"cohorts C if there is evidence of subclinic M1 assessed by 18F-FDG PET/CT at screening Interventional: Perjeta+Herceptin+Carboplatin+Docetaxel during 6 cycles. Patients will continue with Perjeta+Herceptin+Endocrine therapy (tamoxifen or letrozole) after surgery or no surgery.","label":"Cohort C","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2026-11-01","type":"ESTIMATED"},"conditions":["Breast Cancer"],"enrollment":{"count":377,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Perjeta","type":"DRUG"},{"name":"Herceptin","type":"DRUG"},{"name":"Docetaxel","type":"DRUG"},{"name":"Carboplatin","type":"DRUG"},{"name":"Letrozole","type":"DRUG"},{"name":"Tamoxifen","type":"DRUG"}],"last_update":"2025-04-23","lead_sponsor":"MedSIR","official_title":"Chemotherapy-free Trastuzumab and Pertuzumab in HER2-positive (Human Epidermal Receptor) Breast Cancer: FDG-PET Response-adapted Strategy. The PHERGain Study","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE2"],"primary_completion_date":{"date":"2023-11-01","type":"ACTUAL"},"primary_outcomes":[{"measure":"Evaluate the rate of pCR","timeFrame":"After Cycle 6 or 8 (each cycle 21 days- After 4.2 or 5.6 months)"},{"measure":"3-year iDFS rate","timeFrame":"After 3 years (36 months)"}],"references":[{"citation":"Llombart-Cussac A, Prat A, Perez-Garcia JM, Mateos J, Pascual T, Escriva-de-Romani S, Stradella A, Ruiz-Borrego M, de Las Heras BB, Keyaerts M, Galvan P, Braso-Maristany F, Garcia-Mosquera JJ, Guiot T, Gion M, Sampayo-Cordero M, Di Cosimo S, Perez-Escuredo J, de Frutos MA, Cortes J, Gebhart G. Clinicopathological and molecular predictors of [18F]FDG-PET disease detection in HER2-positive early breast cancer: RESPONSE, a substudy of the randomized PHERGain trial. Eur J Nucl Med Mol Imaging. 2024 Jul;51(9):2733-2743. doi: 10.1007/s00259-024-06683-0. Epub 2024 Apr 8.","pmid":"38587643","type":"DERIVED"},{"citation":"Perez-Garcia JM, Cortes J, Ruiz-Borrego M, Colleoni M, Stradella A, Bermejo B, Dalenc F, Escriva-de-Romani S, Calvo Martinez L, Ribelles N, Marme F, Cortes A, Albacar C, Gebhart G, Prat A, Kerrou K, Schmid P, Braga S, Di Cosimo S, Gion M, Antonarelli G, Popa C, Szostak E, Alcala-Lopez D, Gener P, Rodriguez-Morato J, Mina L, Sampayo-Cordero M, Llombart-Cussac A; PHERGain Trial Investigators. 3-year invasive disease-free survival with chemotherapy de-escalation using an 18F-FDG-PET-based, pathological complete response-adapted strategy in HER2-positive early breast cancer (PHERGain): a randomised, open-label, phase 2 trial. Lancet. 2024 Apr 27;403(10437):1649-1659. doi: 10.1016/S0140-6736(24)00054-0. Epub 2024 Apr 3.","pmid":"38582092","type":"DERIVED"},{"citation":"Gebhart G, Keyaerts M, Guiot T, Flamen P, Ruiz-Borrego M, Stradella A, Bermejo B, Escriva-de-Romani S, Calvo Martinez L, Ribelles N, Fernandez-Abad M, Albacar C, Colleoni M, Garrigos L, Atienza de Frutos M, Dalenc F, Prat A, Marme F, Schmid P, Kerrou K, Braga S, Gener P, Sampayo-Cordero M, Cortes J, Perez-Garcia JM, Llombart-Cussac A. Optimal [18F]FDG PET/CT Cutoff for Pathologic Complete Response in HER2-Positive Early Breast Cancer Patients Treated with Neoadjuvant Trastuzumab and Pertuzumab in the PHERGain Trial. J Nucl Med. 2024 May 1;65(5):708-713. doi: 10.2967/jnumed.123.266384.","pmid":"38575192","type":"DERIVED"},{"citation":"Perez-Garcia JM, Gebhart G, Borrego MR, Schmid P, Marme F, Prat A, Dalenc F, Kerrou K, Colleoni M, Braga S, Malfettone A, Sampayo-Cordero M, Cortes J, Llombart-Cussac A. Trastuzumab and pertuzumab without chemotherapy in early-stage HER2+ breast cancer: a plain language summary of the PHERGain study. Future Oncol. 2022 Oct;18(33):3677-3688. doi: 10.2217/fon-2022-0663. Epub 2022 Oct 27.","pmid":"36300423","type":"DERIVED"},{"citation":"Perez-Garcia JM, Gebhart G, Ruiz Borrego M, Stradella A, Bermejo B, Schmid P, Marme F, Escriva-de-Romani S, Calvo L, Ribelles N, Martinez N, Albacar C, Prat A, Dalenc F, Kerrou K, Colleoni M, Afonso N, Di Cosimo S, Sampayo-Cordero M, Malfettone A, Cortes J, Llombart-Cussac A; PHERGain steering committee and trial investigators. Chemotherapy de-escalation using an 18F-FDG-PET-based pathological response-adapted strategy in patients with HER2-positive early breast cancer (PHERGain): a multicentre, randomised, open-label, non-comparative, phase 2 trial. Lancet Oncol. 2021 Jun;22(6):858-871. doi: 10.1016/S1470-2045(21)00122-4. Epub 2021 May 18.","pmid":"34019819","type":"DERIVED"}],"start_date":{"date":"2017-06-26","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Chemotherapy-free Trastuzumab and Pertuzumab in HER2-positive Breast Cancer: FDG-PET Response-adapted Strategy.","url":"https://clinicaltrials.gov/study/NCT03161353"},"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/phergain-nct03161353"}