Use of Sentinel Lymph Node Biopsy in Patients With Early-Stage, Palpable Node-Positive HR+/HER2- Breast Cancer Having Upfront Surgery and Adjuvant Radiation

Selective Use of ALND in N1 HR+/HER2- Breast Cancer Patients With 1 or 2 Positive Sentinel Lymph Nodes Undergoing Upfront Breast Surgery and Adjuvant Radiation: A Prospective Study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04854005

Enrollment

Registered

2021-04-22

Start date

2021-05-20

Completion date

2027-04-01

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Sentinel Lymph Node Biopsy, Palpable Node-Positive HR+/HER2, 21-183

Brief summary

The purpose of this study is to find out how often the researchers can avoid an ALND in patients with early-stage, node-positive HR+/HER2- breast cancer who are having upfront surgery. The study researchers think that, if AUS before surgery can help identify people who may have up to 3 affected lymph nodes, it will be possible to perform the less radical standard SLNB during surgery.

Interventions

PROCEDUREBreast surgery

Patients will undergo SLNB with single or dual-tracer lymphatic with technetium-99m sulfur colloid either lymphazurin or methylene blue dye, per institution standard, in accordance with routine clinical practice.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients aged ≥18 years with biopsy-proven invasive breast cancer * Patients with cTx, cT1, or cT2 tumors with palpable ipsilateral mobile adenopathy of level I/II axillary nodes with biopsy-proven (either by pre-operative biopsy or intraoperative frozen section) nodal metastasis (cN1) who are undergoing upfront surgery * Patients with tumors of the HR+/HER2- subtype, defined as: 1. HR+: Positive for estrogen receptor and/or progesterone receptor staining, indicated by ≥1% immunoreactive tumor nuclei 2. HER2-: Immunohistochemistry assay demonstrating no or faint staining in ≤10% of tumor cells (IHC 0 or 1+) or negative by dual probe in situ hybridization assay

Exclusion criteria

* Patients with prior ipsilateral breast cancer * Patients who are pregnant * Patients with stage IV disease at presentation * Patients with advanced regional disease (cN2/cN3)

Design outcomes

Primary

Measure	Time frame	Description
evaluate rates of axillary lymph node dissection	2 years	Completion ALND will be required if metastases are present in ≥3 SLNs on pathologic evaluation.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORAnita Mamtani, MD

Memorial Sloan Kettering Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 4, 2026