{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,10]],"date-time":"2026-10-10T15:17:18Z","timestamp":1791645438636,"version":"4.3.4"},"reference-count":26,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"21","content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"short-container-title":["JCO"],"published-print":{"date-parts":[[2021,7,20]]},"abstract":"<jats:sec><jats:title>PURPOSE<\/jats:title><jats:p> Preclinical studies report that trastuzumab (T) can boost radiotherapy (RT) effectiveness. The primary aim of the B-43 trial was to assess the efficacy of RT alone vs concurrent RT plus T in preventing recurrence of ipsilateral breast cancer (IBTR) in women with ductal carcinoma in situ (DCIS). <\/jats:p><\/jats:sec><jats:sec><jats:title>PATIENTS AND METHODS<\/jats:title><jats:p> Eligibility: Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, DCIS resected by lumpectomy, known estrogen receptor (ER) and\/or progesterone receptor (PgR), and human epidermal growth factor receptor 2 (HER2) status by centralized testing. Whole-breast RT was given concurrently with T. Stratification was by menopausal status, adjuvant endocrine therapy plan, and nuclear grade. Definitive intent-to-treat primary analysis was to be conducted when either 163 IBTR events occurred or all accrued patients were on study \u2265 5 years. <\/jats:p><\/jats:sec><jats:sec><jats:title>RESULTS<\/jats:title><jats:p> There were 2,014 participants who were randomly assigned. Median follow-up time as of December 31, 2019, was 79.2 months. At primary definitive analysis, 114 IBTR events occurred: RT arm, 63 and RT plus T arm, 51 (hazard ratio [HR], 0.81; 95% CI, 0.56 to 1.17; P value = .26). There were 34 who were invasive: RT arm, 18 and RT plus T arm, 20 (HR, 1.11; 95% CI, 0.59 to 2.10; P value = .71). Seventy-six were DCIS: RT arm, 45 and RT plus T arm, 31 (HR, 0.68; 95% CI, 0.43 to 1.08; P value = .11). Annual IBTR event rates were: RT arm, 0.99%\/y and RT plus T arm, 0.79%\/y. The study did not reach the 163 protocol-specified events, so the definitive analysis was triggered by all patients having been on study for \u2265 5 years. <\/jats:p><\/jats:sec><jats:sec><jats:title>CONCLUSION<\/jats:title><jats:p> Addition of T to RT did not achieve the objective of 36% reduction in IBTR rate but did achieve a modest but statistically nonsignificant reduction of 19%. Nonetheless, this trial had negative results. Further exploration of RT plus T is needed in HER2-positive DCIS before its routine delivery in patients with DCIS resected by lumpectomy. <\/jats:p><\/jats:sec>","DOI":"10.1200\/jco.20.02824","type":"journal-article","created":{"date-parts":[[2021,3,19]],"date-time":"2021-03-19T19:59:44Z","timestamp":1616183984000},"page":"2367-2374","update-policy":"https:\/\/doi.org\/10.1200\/crossmark","source":"Crossref","is-referenced-by-count":30,"title":["Comparison of Radiation With or Without Concurrent Trastuzumab for HER2-Positive Ductal Carcinoma In Situ Resected by Lumpectomy: A Phase III Clinical Trial"],"prefix":"10.1200","volume":"39","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6385-4693","authenticated-orcid":false,"given":"Melody A.","family":"Cobleigh","sequence":"first","affiliation":[{"name":"NRG Oncology, Pittsburgh, PA"},{"name":"Rush University Medical Center, Chicago, IL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8948-0650","authenticated-orcid":false,"given":"Stewart J.","family":"Anderson","sequence":"additional","affiliation":[{"name":"NRG Oncology, Pittsburgh, PA"},{"name":"University of Pittsburgh, Pittsburgh, PA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8689-5508","authenticated-orcid":false,"given":"Kalliopi P.","family":"Siziopikou","sequence":"additional","affiliation":[{"name":"NRG Oncology, Pittsburgh, PA"},{"name":"Northwestern University Feinberg School of Medicine, Chicago, IL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Douglas W.","family":"Arthur","sequence":"additional","affiliation":[{"name":"NRG Oncology, Pittsburgh, PA"},{"name":"Massey Cancer Center, Virginia Commonwealth University, Richmond, VA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rachel","family":"Rabinovitch","sequence":"additional","affiliation":[{"name":"NRG Oncology, Pittsburgh, PA"},{"name":"University of Colorado Cancer Center, Aurora, CO"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas B.","family":"Julian","sequence":"additional","affiliation":[{"name":"NRG Oncology, Pittsburgh, PA"},{"name":"Allegheny Health Network, Pittsburgh, PA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David S.","family":"Parda","sequence":"additional","affiliation":[{"name":"NRG Oncology, Pittsburgh, PA"},{"name":"Allegheny Health Network, Pittsburgh, PA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Samantha A.","family":"Seaward","sequence":"additional","affiliation":[{"name":"NRG Oncology, Pittsburgh, PA"},{"name":"Kaiser Permanente Cancer Research Program, Vallejo, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dennis L.","family":"Carter","sequence":"additional","affiliation":[{"name":"Rocky Mountain Cancer Centers, Aurora, CO"},{"name":"US Oncology, The Woodlands, TX"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Janice A.","family":"Lyons","sequence":"additional","affiliation":[{"name":"University Hospitals Seidman Cancer Center, Cleveland, OH"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Melissa S.","family":"Dillmon","sequence":"additional","affiliation":[{"name":"Harbin Clinic, Rome, GA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0064-4071","authenticated-orcid":false,"given":"Gustav C.","family":"Magrinat","sequence":"additional","affiliation":[{"name":"NRG Oncology, Pittsburgh, PA"},{"name":"Cone Health Center, Greensboro, NC"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0460-1730","authenticated-orcid":false,"given":"Vivek S.","family":"Kavadi","sequence":"additional","affiliation":[{"name":"NRG Oncology, Pittsburgh, PA"},{"name":"US Oncology, The Woodlands, TX"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8626-6998","authenticated-orcid":false,"given":"Allison M.","family":"Zibelli","sequence":"additional","affiliation":[{"name":"Sidney Kimmel Cancer Center, Thomas Jefferson University, Philadelphia, PA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lavanya","family":"Tiriveedhi","sequence":"additional","affiliation":[{"name":"NRG Oncology, Pittsburgh, PA"},{"name":"Mercy Clinic Cancer and Hematology, Springfield, MO"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthew L.","family":"Hill","sequence":"additional","affiliation":[{"name":"NRG Oncology, Pittsburgh, PA"},{"name":"Mission Cancer and Blood, Des Moines, IA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marianne K.","family":"Melnik","sequence":"additional","affiliation":[{"name":"NRG Oncology, Pittsburgh, PA"},{"name":"Cancer Research Consortium of West Michigan, Grand Rapids, MI"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4920-4595","authenticated-orcid":false,"given":"Sushil","family":"Beriwal","sequence":"additional","affiliation":[{"name":"NRG Oncology, Pittsburgh, PA"},{"name":"UPMC Hillman Cancer Center, Magee Womens Hospital, Pittsburgh, PA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9476-2553","authenticated-orcid":false,"given":"Eleftherios P.","family":"Mamounas","sequence":"additional","affiliation":[{"name":"NRG Oncology, Pittsburgh, PA"},{"name":"Orlando Health UF Health Cancer Center, Orlando, FL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Norman","family":"Wolmark","sequence":"additional","affiliation":[{"name":"NRG Oncology, Pittsburgh, PA"},{"name":"University of Pittsburgh, Pittsburgh, PA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"233","reference":[{"key":"B1","volume-title":"Cancer Facts & Figures 2020","author":"American Cancer Society","year":"2020"},{"key":"b2","doi-asserted-by":"publisher","DOI":"10.1042\/BSR20130077"},{"key":"b3","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM198811103191902"},{"key":"b4","first-page":"199","volume":"11","author":"Bobrow LG","year":"1994","journal-title":"Semin Diagn Pathol"},{"key":"b5","first-page":"208","volume":"11","author":"Zafrani B","year":"1994","journal-title":"Semin Diagn Pathol"},{"key":"b6","doi-asserted-by":"publisher","DOI":"10.1002\/1097-0142(19950415)75:8<2123::AID-CNCR2820750815>3.0.CO;2-V"},{"key":"b7","doi-asserted-by":"publisher","DOI":"10.1016\/0959-8049(96)00037-8"},{"key":"b8","doi-asserted-by":"publisher","DOI":"10.1016\/S0046-8177(97)90014-9"},{"key":"b9","doi-asserted-by":"publisher","DOI":"10.1093\/jncimonographs\/lgq039"},{"key":"b10","doi-asserted-by":"publisher","DOI":"10.1054\/bjoc.2000.1618"},{"key":"b11","doi-asserted-by":"publisher","DOI":"10.1158\/1078-0432.CCR-18-0201"},{"key":"b12","doi-asserted-by":"publisher","DOI":"10.1097\/MD.0000000000013055"},{"key":"b13","doi-asserted-by":"publisher","DOI":"10.1158\/1078-0432.CCR-16-1924"},{"key":"b14","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.1999.17.9.2639"},{"key":"b15","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijrobp.2006.05.036"},{"key":"b16","first-page":"1113","volume":"2","author":"Liang K","year":"2003","journal-title":"Mol Cancer Ther"},{"key":"b17","doi-asserted-by":"publisher","DOI":"10.1089\/cbr.2009.0699"},{"key":"b18","doi-asserted-by":"publisher","DOI":"10.1038\/sj.onc.1207149"},{"key":"b19","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2005.00.661"},{"key":"b20","doi-asserted-by":"publisher","DOI":"10.1080\/01621459.1993.10476289"},{"key":"b21","doi-asserted-by":"publisher","DOI":"10.1080\/01621459.1999.10474144"},{"key":"b22","doi-asserted-by":"publisher","DOI":"10.1093\/jnci\/djr027"},{"key":"b23","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(15)01168-X"},{"key":"b24","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2013.49.5077"},{"key":"b25","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2007.12.7969"},{"key":"b26","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(10)70266-7"}],"container-title":["Journal of Clinical Oncology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/ascopubs.org\/doi\/pdfdirect\/10.1200\/JCO.20.02824","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,5,29]],"date-time":"2022-05-29T08:12:36Z","timestamp":1653811956000},"score":1,"resource":{"primary":{"URL":"https:\/\/ascopubs.org\/doi\/10.1200\/JCO.20.02824"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,7,20]]},"references-count":26,"journal-issue":{"issue":"21","published-print":{"date-parts":[[2021,7,20]]}},"alternative-id":["10.1200\/JCO.20.02824"],"URL":"https:\/\/doi.org\/10.1200\/jco.20.02824","relation":{},"ISSN":["0732-183X","1527-7755"],"issn-type":[{"value":"0732-183X","type":"print"},{"value":"1527-7755","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,7,20]]},"assertion":[{"value":"2020-09-15","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-12-09","order":1,"name":"revised","label":"Revised","group":{"name":"publication_history","label":"Publication History"}},{"value":"2021-01-07","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2021-03-19","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}