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

Breast Cancer Female Clinical Trial

Official title:
Safety of Axillary Sentinel or Targeted Lymph Node Biopsy Alone After Neoadjuvant Chemotherapy in Breast Cancer With Initial Axillary Metastasis

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05141630
Study type Interventional
Source Fudan University
Contact Zhi-Min Shao
Phone +86 21 6417 5590
Email zhimingshao@yahoo.com
Status Recruiting
Phase Phase 2
Start date January 1, 2014
Completion date January 1, 2024
View Details
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