{"commentary":{"count":9,"free_build_floor":8,"listing_floor":3,"by_channel":{"youtube":6,"podcast":2,"x_thread":1},"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\": \"NCT03493854\", \"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":"FeDeriCa","nct_id":"NCT03493854","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=federica-nct03493854. 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":750,"size":"focused","size_rule":"Focused: 1–12 commentary sources"},"registry":{"acronym":"FeDeriCa","arms":[{"description":"Participants will receive 8 cycles of investigator's choice of neoadjuvant chemotherapy. This will include either: 1) 4 cycles of dose-dense doxorubicin plus cyclophosphamide (ddAC) once every 2 weeks (Q2W) (given with granulocyte colony-stimulating factor \\[G-CSF\\] support as needed according to local guidelines) followed by paclitaxel Q1W for 12 weeks; or 2) 4 cycles of doxorubicin plus cyclophosphamide (AC) once every 3 weeks (Q3W) followed by docetaxel Q3W for 4 cycles. Pertuzumab and trastuzumab will be given intravenously (IV) for 4 cycles Q3W concurrently with the taxane component of chemotherapy. After completing their neoadjuvant therapy, participants will undergo surgery. Thereafter, participants will receive an additional 14 cycles of pertuzumab IV and trastuzumab IV for a total of 18 cycles.","label":"Arm A: Pertuzumab IV + Trastuzumab IV + Chemotherapy","type":"ACTIVE_COMPARATOR"},{"description":"Participants will receive 8 cycles of investigator's choice of neoadjuvant chemotherapy. This will include either: 1) 4 cycles of ddAC Q2W (given with G-CSF support as needed according to local guidelines) followed by paclitaxel once every week (QW) for 12 weeks; or 2) 4 cycles of AC Q3W followed by docetaxel Q3W for 4 cycles. The fixed-dose combination (FDC) of pertuzumab and trastuzumab will be given subcutaneously (SC) for 4 cycles (Q3W) concurrently with the taxane component of chemotherapy. After completing their neoadjuvant therapy, participants will undergo surgery. Thereafter, participants will receive an additional 14 cycles of the FDC of pertuzumab and trastuzumab SC for a total of 18 cycles.","label":"Arm B: FDC of Pertuzumab and Trastuzumab SC + Chemotherapy","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2023-06-02","type":"ACTUAL"},"conditions":["Early Breast Cancer"],"enrollment":{"count":500,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Cyclophosphamide","type":"DRUG"},{"name":"Doxorubicin","type":"DRUG"},{"name":"Docetaxel","type":"DRUG"},{"name":"Paclitaxel","type":"DRUG"},{"name":"Pertuzumab IV","type":"DRUG"},{"name":"FDC of Pertuzumab and Trastuzumab SC","type":"DRUG"},{"name":"Trastuzumab IV","type":"DRUG"},{"name":"Trastuzumab SC","type":"DRUG"},{"name":"Surgery","type":"PROCEDURE"},{"name":"Post-operative Radiotherapy","type":"RADIATION"},{"name":"Hormone Therapy","type":"DRUG"}],"last_update":"2024-06-26","lead_sponsor":"Hoffmann-La Roche","official_title":"A Phase III, Randomized, Multicenter, Open-Label, Two-Arm Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Combination With Chemotherapy in Patients With HER2-Positive Early Breast Cancer","overall_status":"COMPLETED","phases":["PHASE3"],"primary_completion_date":{"date":"2019-07-04","type":"ACTUAL"},"primary_outcomes":[{"measure":"Trough Serum Concentration (Ctrough) of Pertuzumab During Cycle 7 (Pre-Dose Cycle 8)","timeFrame":"Pre-dose on Cycle 8, Day 1 (up to 21 weeks)"}],"references":[{"citation":"Tan AR, Im SA, Mattar A, Colomer R, Stroyakovskii D, Nowecki Z, De Laurentiis M, Pierga JY, Jung KH, Schem C, Hogea A, Badovinac Crnjevic T, Heeson S, Shivhare M, Kirschbrown WP, Restuccia E, Jackisch C; FeDeriCa study group. Fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection plus chemotherapy in HER2-positive early breast cancer (FeDeriCa): a randomised, open-label, multicentre, non-inferiority, phase 3 study. Lancet Oncol. 2021 Jan;22(1):85-97. doi: 10.1016/S1470-2045(20)30536-2. Epub 2020 Dec 21.","pmid":"33357420","type":"DERIVED"}],"start_date":{"date":"2018-06-14","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Combination With Chemotherapy in Participants With HER2-Positive Early Breast Cancer","url":"https://clinicaltrials.gov/study/NCT03493854"},"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/federica-nct03493854"}