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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hartford Healthcare Cancer Alliance (Data collection only), Hartford, Connecticut, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

HR+: Positive for estrogen receptor and/or progesterone receptor staining, indicated by ≥1% immunoreactive tumor nuclei
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)

Treatment and study plan

Breast surgery

Procedure

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.

Primary outcomes

evaluate rates of axillary lymph node dissection

Time frame: 2 years

Completion ALND will be required if metastases are present in ≥3 SLNs on pathologic evaluation.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start: 2021
Primary completion: 2027
Study completion: 2027
First posted: Apr 22, 2021
Registry last updated: May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting