Omission of ALND in Breast Cancer Patients With Axillary pCR

This prospective, single-arm, phase II trial studies axillary lymph node dissection (ALND) to see if it can be safely omitted in breast cancer patients with axillary pathological complete response (pCR) after neoadjuvant systemic therapy (NST). Breast cancer patients with biopsy-proven positive axillary lymph nodes at initial diagnosis, and converted to negative after NST, which is confirmed by Stained region Lymph Node Biopsy(SrLNB), will be enrolled in the study. In other words, a total of 92 patients will be exempted from ALND after SrLNB, and afterwards complete regional node irradiation (

Trial Details

NCT ID
NCT05939830
Phase
NA
Sponsor
The First Affiliated Hospital with Nanjing Medical University
Status
RECRUITING
Cancer Type
Breast Cancer
Interventions
  • Stained region Lymph Node Biopsy (SrLNB)
  • Regional lymph node radiotherapy (RNI) including the axilla
Locations (sample)
  • Nanjing, China|32.06167,118.77778

Key Eligibility Criteria

  • Female aged between 18 and 70 years;
  • Pathologically confirmed invasive breast cancer (regardless of pathological type) with a clinical stage cT1-3;
  • Pathologically confirmed positive axillary lymph nodes with a clinical stage of N1-3;
  • Receiving a full course of neoadjuvant therapy (including neoadjuvant chemotherapy, neoadjuvant targeted therapy, neoadjuvant immunotherapy);

For full eligibility, visit ClinicalTrials.gov.

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