NSABP B-51 / RTOG 1304

  • The NSABP B-51 / RTOG 1304 trial:
    • Is a phase III randomized clinical trial currently accruing patients
    • That is designed to evaluate the role of regional nodal radiotherapy (RT):
      • In patients who had documented positive axillary lymph nodes prior to undergoing NAC:
        • Who subsequently convert to pathologically negative axillary nodes after the administration of NAC
    • The primary endpoint:
      • Is to determine if regional nodal RT:
        • Significantly reduces the rate of in-breast cancer recurrence free interval
    • Node positivity:
      • Will be documented by either FNA or core needle biopsy:
        • Prior to the administration of NAC
    • Patients will undergo standard NAC with the addition of anti-HER2 therapy for patients with HER2-positive tumors
    • Patients can have either mastectomy or breast-conserving therapy:
      • Mastectomy patients will be randomized to:
        • Either no RT or regional nodal RT and chest wall RT
      • Breast conservation patients will be randomized to either:
        • Whole-breast RT or whole-breast RT plus regional nodal RT
  • References: