Axillary Sentinel or Targeted Lymph Node Biopsy Alone After Neoadjuvant Chemotherapy in Node-positive Breast Cancer

  • STATUS
    Recruiting
  • End date
    Jan 1, 2024
  • participants needed
    100
  • sponsor
    Fudan University
Updated on 11 December 2021

Summary

This randomized phase II trial investigates the effectiveness of axillary sentinel or targeted lymph node biopsy alone after neoadjuvant chemotherapy (NAC) in breast cancer patients with initial axillary metastasis. For patients with the low nodal disease after NAC, it is not yet known if radiation therapy causes fewer side effects without compromising loco-regional control.

Description

To evaluate long-term survival and life quality in patients with biopsy-proven node-positive (cN1-N2) breast cancer receiving NAC, followed by limited nodal burden (less than two positive lymph nodes) by using a (sentinel lymph node biopsy) SLNB or targeted axillary dissection (TAD) technique, and no further axillary surgery.

OUTLINE

Eligible patients with cT1 to cT3 biopsy-proven N1-2 breast cancer rendered cN0 by NAC underwent SLNB with dual tracer mapping or TAD, and omission of ALND if 2 or more biopsied nodes were identified and less than 2 biopsied nodes were pathologically positve. Metastatic nodes were not routinely clipped, and localization of clipped nodes was performed in these patients. The study was performed in a single cancer center.

After study treatment, patients are followed up at least every 6 months for 2 years and then annually for 3 years.

PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study within 10 years.

Details
Condition Breast Cancer Female
Treatment sentinel lymph node biopsy or targeted axillary dissection alone
Clinical Study IdentifierNCT05141630
SponsorFudan University
Last Modified on11 December 2021

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