{"preliminary_commentary":{"by_channel":{"bluesky_thread":2,"x_thread":1},"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":false},"name":"NCT02945579","nct_id":"NCT02945579","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct02945579. 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":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"* Neoadjuvant chemotherapy therapy\n* Biopsy: if no disease remaining - stay on the study and receive radiation (skip breast surgery)\n* H\\&P and Imaging every 6 months\n\nTreatment (whole breast irradiation, EBRT) Within 12 weeks of completing neoadjuvant systemic therapy, patients undergo whole breast irradiation over 15-25 fractions on consecutive days. Patients then undergo EBRT boost over 7 fractions on consecutive days beginning the day following completion of whole breast irradiation.","label":"Cohort A","type":"EXPERIMENTAL"},{"description":"• Neoadjuvant endocrine therapy for 3 months\n\nCohort B Radiation:\n\nTreatment (Stereotactic ablative radiotherapy -SABR) Following 3-6 months of endocrine therapy, if less than 25% tumor increase, patients undergo SABR irradiation over 5 fractions\n\n* Continued endocrine therapy for total of 5 years Biopsy 6-12months after radiation: if negative - additional endocrine therapy under the guidance of medical oncologist (skip breast surgery)\n* H\\&P and Imaging every 6 months","label":"Cohort B","type":"EXPERIMENTAL"},{"description":"* Optional biopsy for nanomechanical biomarker assessment\n* Neoadjuvant chemotherapy therapy\n* Surgery (\\& optional biopsy nanomechanical biomarker assessment): if no disease remaining - stay on the study and skip radiation\n* H\\&P and Imaging every 6 months","label":"Cohort C","type":"EXPERIMENTAL"},{"description":"* Optional biopsy for nanomechanical biomarker assessment\n* Chart review every year after surgery for 5 years\n* Eligible patients who have undergone the optional biopsy may later move to Cohort A or C if they meet all eligibility requirements and desire radiation omission.","label":"Cohort D","type":"EXPERIMENTAL"}],"collaborators":["National Cancer Institute (NCI)"],"completion_date":{"date":"2028-01-31","type":"ESTIMATED"},"conditions":["Estrogen Receptor Negative","HER2 Positive Breast Carcinoma","HER2/Neu Negative","Invasive Breast Carcinoma","Progesterone Receptor Negative","Stage I Breast Cancer AJCC v7","Stage IA Breast Cancer AJCC v7","Stage IB Breast Cancer AJCC v7","Stage II Breast Cancer AJCC v6 and v7","Stage IIA Breast Cancer AJCC v6 and v7","Stage IIB Breast Cancer AJCC v6 and v7","Triple-Negative Breast Carcinoma"],"enrollment":{"count":120,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"Undergo EBRT","otherNames":["Definitive Radiation Therapy","SABR","External Beam Radiation Therapy","External Beam Radiotherapy","External Beam RT","external radiation","External Radiation Therapy","external-beam radiation"],"type":"RADIATION"},{"name":"Laboratory Biomarker Analysis","otherNames":[],"type":"OTHER"},{"name":"Quality-of-Life Assessment","otherNames":["Quality of Life Assessment"],"type":"OTHER"},{"name":"Questionnaire Administration","otherNames":[],"type":"OTHER"},{"name":"Partial Breast Irradiation","otherNames":[],"type":"RADIATION"}],"last_update":"2026-09-25","lead_sponsor":"M.D. Anderson Cancer Center","official_title":"Multicenter Trial for Eliminating Breast Cancer Surgery or Radiotherapy in Exceptional Responders to Neoadjuvant Systemic Therapy","overall_status":"RECRUITING","phases":["NA"],"primary_completion_date":{"date":"2028-01-31","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Ipsilateral breast tumor recurrence-free survival (IBT-RFS)","timeFrame":"From confirmation of pathologic complete response (pCR) to the time of ipsilateral breast tumor recurrence or death, whichever occurs first or the time of last contact, assessed for up to 10 years"},{"measure":"Overall survival","timeFrame":"Up to 10 years"}],"references":[{"citation":"Kuerer HM, Valero V, Smith BD, Krishnamurthy S, Diego EJ, Johnson HM, Lin H, Shen Y, Lucci A, Shaitelman SF, Mitchell MP, Boughey JC, White RL, Hunt KK, Yang WT, Rauch GM; Exceptional Responders Study Group. Selective Elimination of Breast Surgery for Invasive Breast Cancer: A Nonrandomized Clinical Trial. JAMA Oncol. 2025 May 1;11(5):529-534. doi: 10.1001/jamaoncol.2025.0207.","pmid":"40152443","type":"DERIVED"},{"citation":"Johnson HM, Lin H, Shen Y, Diego EJ, Krishnamurthy S, Yang WT, Smith BD, Valero V, Lucci A, Sun SX, Shaitelman SF, Mitchell MP, Boughey JC, White RL, Rauch GM, Kuerer HM; Exceptional Responders Study Group. Patient-Reported Outcomes of Omission of Breast Surgery Following Neoadjuvant Systemic Therapy: A Nonrandomized Clinical Trial. JAMA Netw Open. 2023 Sep 5;6(9):e2333933. doi: 10.1001/jamanetworkopen.2023.33933.","pmid":"37707811","type":"DERIVED"},{"citation":"Kuerer HM, Smith BD, Krishnamurthy S, Yang WT, Valero V, Shen Y, Lin H, Lucci A, Boughey JC, White RL, Diego EJ, Rauch GM; Exceptional Responders Clinical Trials Group. Eliminating breast surgery for invasive breast cancer in exceptional responders to neoadjuvant systemic therapy: a multicentre, single-arm, phase 2 trial. Lancet Oncol. 2022 Dec;23(12):1517-1524. doi: 10.1016/S1470-2045(22)00613-1. Epub 2022 Oct 25.","pmid":"36306810","type":"DERIVED"},{"citation":"Hariharan N, Rao TS, Rajappa S, Naidu CCK. Precision medicine - A new era in multidisciplinary care. Cancer Treat Res Commun. 2022;32:100577. doi: 10.1016/j.ctarc.2022.100577. Epub 2022 May 17. No abstract available.","pmid":"35617923","type":"DERIVED"}],"start_date":{"date":"2017-01-20","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Multicenter Trial for Eliminating Breast Cancer Surgery or Radiotherapy in Exceptional Responders to Neoadjuvant Systemic Therapy","url":"https://clinicaltrials.gov/study/NCT02945579"},"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/nct02945579"}