{"entity":{"id":"milan-i","kind":"trial","name":"Milan I (quadrantectomy against radical mastectomy)","aka":["Milan trial","Veronesi quadrantectomy trial","QUART"],"tldr":"Umberto Veronesi ran the European half of the argument, against the most mutilating operation in surgery. After twenty years, women who had a quarter of the breast removed and radiotherapy were as likely to be alive as women who had the breast, the chest muscles and the nodes taken away.","summary":"Between 1973 and 1980, 701 women with breast cancers of 2 cm or less were randomised at the Istituto Nazionale Tumori in Milan to Halsted radical mastectomy (349) or to quadrantectomy with axillary dissection followed by radiotherapy to the remaining breast tissue (352). From 1976 node-positive women in both arms received cyclophosphamide, methotrexate and fluorouracil.\n\nAt twenty years, thirty women in the conservation arm had a recurrence in the same breast against eight in the mastectomy arm, a crude cumulative incidence of 8.8 against 2.3 percent (p<0.001). Nothing else differed: contralateral breast cancers, distant metastases and second primary cancers were the same in both arms. Death from any cause was 41.7 percent after conservation and 41.2 percent after radical mastectomy (p=1.0); death from breast cancer 26.1 against 24.3 percent (p=0.8).\n\nRead alongside NSABP B-06, Milan I is the reason the sentence \"breast conservation is the treatment of choice for relatively small breast cancers\" can be written at all. It also shows the shape of the trade: a higher chance of the cancer returning in the breast, paid for by keeping the breast, with no cost in life. Quadrantectomy itself, which takes a whole quadrant, is more than most surgeons remove now, and the 8.8 percent figure was achieved without the modern systemic therapy that lowers local recurrence further.","status":"positive","asOf":"2026-09-25","links":[{"label":"Milan I twenty-year follow-up (New England Journal of Medicine 2002)","url":"https://doi.org/10.1056/NEJMoa020989"}],"tags":[],"related":[],"cancers":["breast-cancer","breast-hr-positive","breast-her2-positive","tnbc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":["ieo-milan"],"pathways":[],"terms":["lumpectomy","mastectomy","breast-conserving-surgery-versus-mastectomy","oncoplastic-breast-surgery"],"trials":["nsabp-b06","eortc-10801"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"Breast cancer 2 cm or smaller: Halsted radical mastectomy against quadrantectomy with axillary dissection and breast radiotherapy, with long-term survival as the endpoint","sponsor":"Istituto Nazionale Tumori, Milan","result":"Twenty-year same-breast recurrence 8.8 percent after quadrantectomy against 2.3 percent after radical mastectomy, with identical survival (death from any cause 41.7 against 41.2 percent, p=1.0).","yearReported":2002,"enrolled":701,"enrolledBasis":"randomised","enrolledNote":"The trial randomised 701 women between 1973 and 1980, before any trial registry existed, so there is no registry figure.","outcomes":[{"endpoint":"Crude cumulative incidence of ipsilateral breast recurrence at 20 years","primary":true,"unit":"%","arms":[{"name":"Quadrantectomy with radiotherapy","n":352,"value":8.8},{"name":"Halsted radical mastectomy","n":349,"value":2.3}],"p":"<0.001","source":"https://doi.org/10.1056/NEJMoa020989"},{"endpoint":"Death from any cause at 20 years","unit":"%","arms":[{"name":"Quadrantectomy with radiotherapy","n":352,"value":41.7},{"name":"Halsted radical mastectomy","n":349,"value":41.2}],"p":"1.0","source":"https://doi.org/10.1056/NEJMoa020989"},{"endpoint":"Death from breast cancer at 20 years","unit":"%","arms":[{"name":"Quadrantectomy with radiotherapy","n":352,"value":26.1},{"name":"Halsted radical mastectomy","n":349,"value":24.3}],"p":"0.8","source":"https://doi.org/10.1056/NEJMoa020989"}],"replication":"NSABP B-06 reached the same conclusion in a North American population with a smaller operation; EORTC 10801 confirmed it at twenty years against modified radical mastectomy."},"route":"/trials/milan-i/","neighbours":{"cancer":[{"id":"breast-cancer","kind":"cancer","name":"Breast cancer (all types)","route":"/cancers/breast-cancer/"},{"id":"breast-her2-positive","kind":"cancer","name":"HER2-positive breast cancer","route":"/cancers/breast-her2-positive/"},{"id":"breast-hr-positive","kind":"cancer","name":"HR-positive / HER2-negative breast cancer","route":"/cancers/breast-hr-positive/"},{"id":"tnbc","kind":"cancer","name":"Triple-negative breast cancer (TNBC)","route":"/cancers/tnbc/"}],"institution":[{"id":"ieo-milan","kind":"institution","name":"IEO (European Institute of Oncology)","route":"/institutions/ieo-milan/"}],"term":[{"id":"breast-conserving-surgery-versus-mastectomy","kind":"term","name":"Breast conservation or mastectomy","route":"/terms/breast-conserving-surgery-versus-mastectomy/"},{"id":"lumpectomy","kind":"term","name":"Lumpectomy (breast-conserving surgery)","route":"/terms/lumpectomy/"},{"id":"mastectomy","kind":"term","name":"Mastectomy","route":"/terms/mastectomy/"},{"id":"oncoplastic-breast-surgery","kind":"term","name":"Oncoplastic breast surgery","route":"/terms/oncoplastic-breast-surgery/"}],"trial":[{"id":"eortc-10801","kind":"trial","name":"EORTC 10801","route":"/trials/eortc-10801/"},{"id":"nsabp-b06","kind":"trial","name":"NSABP B-06","route":"/trials/nsabp-b06/"}]}}