Omission of ALND in Breast Cancer Patients With Axillary pCR

Status Recruiting

Clinical Trial Summary

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 (RNI) including the axilla. They will also undergo adjuvant chemotherapy, targeted therapy, endocrinotherapy after surgery. These patients will be followed up in the next three years for local-regional recurrence and long-time survival outcome.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05939830
Study type	Interventional
Source	The First Affiliated Hospital with Nanjing Medical University
Contact	Jue Wang, MD
Phone	+862568306360
Email	wangjue200011@njmu.edu.cn
Status	Recruiting
Phase	N/A
Start date	September 11, 2023
Completion date	July 2026

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