NSABP B-04 Trial

  • NSABP B-04:
    • A Protocol for the Evaluation of Radical Mastectomy (RM) and Total Mastectomy (TM) With and Without Radiation in the Primary Treatment of Cancer of the Female Breast:
      • Enrolled 1079 patients with clinically node-negative disease
      • And randomized them to:
        • RM
        • TM plus local-regional axillary radiation
        • TM alone
      • In parallel:
        • 586 patients with clinically node-positive disease:
          • Were randomized to:
            • RM
            • TM plus radiation
    • After 25 years of follow-up:
      • The study failed to demonstrate a significant difference:
        • In long-term outcome between:
          • Clinically node-negative patients:
            • Who received RM and those who received TM plus radiation, or
          • Between clinically node-positive patients:
            • Who received RM and those who received TM with nodal radiation