{"preliminary_commentary":{"by_channel":{"youtube":7,"podcast":6,"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":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT04457596\", \"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."},"commentary_summary":null,"name":"CompassHER2 RD","nct_id":"NCT04457596","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=compassher2-rd-nct04457596. The price is an estimate of verified 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":1250,"size":"standard","size_rule":"Standard: 151–300 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Patients receive T-DM1 IV over 30-90 minutes on day 1 and placebo PO BID on days 1-21. Treatment repeats every 21 days for up to 14 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo echocardiography/multigated acquisition (MUGA) scan and blood sample collection throughout the study. Patients undergo echocardiography/multigated acquisition (MUGA) scan and blood sample collection throughout the study.","label":"Arm I (trastuzumab emtansine, placebo)","type":"ACTIVE_COMPARATOR"},{"description":"Patients receive T-DM1 IV over 30-90 minutes on day 1 and tucatinib PO BID on days 1-21. Treatment repeats every 21 days for up to 14 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo echocardiography/multigated acquisition (MUGA) scan and blood sample collection throughout the study.","label":"Arm II (trastuzumab emtansine, tucatinib)","type":"EXPERIMENTAL"}],"collaborators":["National Cancer Institute (NCI)","Seagen Inc."],"completion_date":{"date":"2035-05-31","type":"ESTIMATED"},"conditions":["Anatomic Stage II Breast Cancer AJCC v8","Anatomic Stage III Breast Cancer AJCC v8","HER2 Positive Breast Carcinoma","Invasive Breast Carcinoma","Multifocal Breast Carcinoma","Synchronous Bilateral Breast Carcinoma","Anatomic Stage I Breast Cancer AJCC v8"],"enrollment":{"count":1056,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Trastuzumab Emtansine","otherNames":[],"type":"BIOLOGICAL"},{"name":"Placebo Administration","otherNames":[],"type":"DRUG"},{"name":"Tucatinib","otherNames":[],"type":"DRUG"},{"name":"Questionnaire Administration","otherNames":[],"type":"OTHER"},{"name":"Quality-of-Life Assessment","otherNames":[],"type":"OTHER"}],"last_update":"2026-06-15","lead_sponsor":"Alliance for Clinical Trials in Oncology","official_title":"The CompassHER2 Trials (COMprehensive Use of Pathologic Response ASSessment to Optimize Therapy in HER2-Positive Breast Cancer): CompassHER2 Residual Disease (RD), A Double-Blinded, Phase III Randomized Trial of T-DM1 and Placebo Compared With T-DM1 and Tucatinib","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE3"],"primary_completion_date":{"date":"2028-01-31","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Modified invasive disease-free survival (iDFS)","timeFrame":"From randomization to one of the following events: invasive local, regional or distant recurrence, invasive contralateral breast cancer or death from any cause, assessed up to 10 years"}],"references":[{"citation":"Boman C, Tranchell C, Liu X, Eriksson Bergman L, Toli MA, Bergh J, Foukakis T, Matikas A. Prognosis After Pathologic Complete Response to Neoadjuvant Therapy in Early-Stage Breast Cancer: A Population-Based Study. J Natl Compr Canc Netw. 2025 Mar 12;23(4):e247093. doi: 10.6004/jnccn.2024.7093.","pmid":"40073831","type":"DERIVED"},{"citation":"O'Sullivan CC, Ballman KV, McCall L, Kommalapati A, Zemla T, Weiss A, Mitchell M, Blinder V, Tung NM, Irvin WJ, Lee M, Goetz MP, Symmans WF, Borges VF, Krop I, Carey LA, Partridge AH. Alliance A011801 (compassHER2 RD): postneoadjuvant T-DM1 + tucatinib/placebo in patients with residual HER2-positive invasive breast cancer. Future Oncol. 2021 Dec;17(34):4665-4676. doi: 10.2217/fon-2021-0753. Epub 2021 Oct 12.","pmid":"34636255","type":"DERIVED"}],"start_date":{"date":"2021-03-02","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"T-DM1 and Tucatinib Compared With T-DM1 Alone in Preventing Relapses in People With High Risk HER2-Positive Breast Cancer, the CompassHER2 RD Trial","url":"https://clinicaltrials.gov/study/NCT04457596"},"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/compassher2-rd-nct04457596"}