# Sentinel Lymph Node Biopsy after Neoadjuvant Chemotherapy in Patients Presenting with Locally Advanced Breast Cancer: A Prospective Study

> **NIH NIH R03** · SLOAN-KETTERING INST CAN RESEARCH · 2022 · $88,500

## Abstract

Project Summary/Abstract
Sentinel lymph node biopsy (SLNB), which involves removal of the first few draining lymph nodes, is the
standard method for staging the axilla in patients with clinically node-negative (cN0) breast cancer undergoing
neoadjuvant chemotherapy (NAC) and is widely accepted, with minimal morbidity. In patients with clinically
positive nodes, axillary lymph node dissection (ALND), or removal of the majority of axillary lymph nodes, was
once the standard of care; however, NAC can eradicate disease in the axillary nodes, with nodal pathologic
complete response (pCR) rates of 40%, thus reducing the need for ALND and consequently minimizing the risk
of lymphedema. Initial small retrospective studies showed that SLNB was inaccurate in this population, with
false-negative rates (FNRs) of 21%-33%. More recently, 4 prospective multi-institutional trials showed that
patients presenting with limited axillary nodal metastases (cN1) can be reliably staged with SLNB after NAC,
with FNRs of <10% with the use of dual-tracer mapping and retrieval of ≥3 sentinel lymph nodes. Patients
presenting with locally advanced breast cancer (LABC)—defined as disease in the breast with skin or chest
wall involvement (cT4) and/or extensive disease in the nodes (cN2/N3)—have not been considered candidates
for SLNB, owing to their heavy disease burden at presentation and the limited evidence that SLNB is accurate
after NAC in this patient population. Furthermore, it was presumed that the substantial tumor burden in patients
with LABC would result in low rates of pCR to NAC, precluding surgical downstaging. However, a recent
retrospective study of 321 patients with LABC treated at Memorial Sloan Kettering Cancer Center
demonstrated high nodal pCR rates (38%), with similar rates between patients with cN1 (43%), cN2 (36%),
and cN3 (32%) disease (p=0.23). The magnitude of reduction in tumor burden with modern NAC in patients
presenting with LABC suggests that a substantial number of women may not benefit from ALND and may be
subjected to unnecessary morbidity. These patients may be candidates for SLNB after NAC, provided that the
procedure accurately predicts axillary nodal status in this population. We hypothesize that a heavy disease
burden in the breast or the regional nodes at presentation is not a contraindication to SLNB in patients whose
disease is downstaged with NAC. We propose a multi-institutional, prospective, single-arm trial to evaluate the
feasibility and FNR of SLNB after NAC in patients presenting with LABC. Eligible patients whose disease is
reduced to cN0 after NAC will undergo SLNB with dual-tracer mapping followed by ALND to assess the FNR of
SLNB. Study findings could lead to significant advances in the surgical management of the axilla after NAC in
patients with LABC, reducing the need for ALND and improving quality of life of survivors.

## Key facts

- **NIH application ID:** 10502586
- **Project number:** 1R03CA259648-01A1
- **Recipient organization:** SLOAN-KETTERING INST CAN RESEARCH
- **Principal Investigator:** Andrea Barrio
- **Activity code:** R03 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $88,500
- **Award type:** 1
- **Project period:** 2022-07-01 → 2024-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10502586

## Citation

> US National Institutes of Health, RePORTER application 10502586, Sentinel Lymph Node Biopsy after Neoadjuvant Chemotherapy in Patients Presenting with Locally Advanced Breast Cancer: A Prospective Study (1R03CA259648-01A1). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10502586. Licensed CC0.

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