Milan I Study

  • Milan I study:
    • Was a prospective randomized trial:
      • Conducted by the Milan Cancer Institute:
        • From 1973 to 1980
  • Milan I played a critical role:
    • In the establishment of breast conserving therapy (BCT):
      • As a preferred mode of treatment:
        • For women with small breast cancers:
          • ≤ 2 cm
  • For this study:
    • 701 women with tumors ≤ 2 cm were enrolled and randomized to:
      • Radical mastectomy (n = 349) versus
      • BCT (quadrantectomy and axillary node dissection) followed by radiotherapy (n = 352)
  • Results from Milan I:
    • Were concurrent with those from:
      • The NSABP B-06 trial
    • Showing no appreciable differences:
      • In long-term survival between the groups:
        • Despite a higher cumulative incidence of recurrence at 20 years in patients treated with BCT
    • Ipsilateral breast tumor recurrence rates after 20 years follow-up were:
      • 8.8% for the BCT group compared to a 2.3% rate of local recurrence for the radical mastectomy group:
        • P<0.001
    • Additionally, there were no significant differences between the two groups:
      • In the rates of:
        • Contralateral breast cancer
        • Distant metastases
        • Secondary primary cancers
  • Overall, Milan I concluded:
    • That long-term survival was the same for women who underwent radical mastectomy as those who received BCT:
      • Thus providing more evidence to support breast-conserving surgery as treatment for women with small cancers


  1. Julian TB, Venditti CA, Duggal S. Landmark clinical trials influencing surgical management of non-invasive and invasive breast cancer. The Breast Journal. 2015:21;60-66.
  2. Veronesi U, Cascinelli N, Mariani L, et al. Twenty-year follow-up of a randomized study comparing breast-conserving surgery with radical mastectomy for early breast cancer. N Engl J Med. 2002;347:1227-1232.

#Arrangoiz #Teacher #BreastSurgeon #CancerSurgeon #SurgicalOncologist #BreastCancer

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