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

Running, not enrolling

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT04854005

Run by

Memorial Sloan Kettering Cancer Center

People needed

78

Starts

2021-05-20

Expected to finish

2027-04-01

Last updated by the study team

2026-08-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• Hartford Healthcare Cancer Alliance (Data collection only) — Hartford, Connecticut, United States
• University of Michigan (Data Collection Only) — Ann Arbor, Michigan, United States
• Memorial Sloan Kettering Basking Ridge (Consent Only) — Basking Ridge, New Jersey, United States
• Memorial Sloan Kettering Monmouth (All Protocol Activities) — Middletown, New Jersey, United States
• Memorial Sloan Kettering Bergen (Consent Only) — Montvale, New Jersey, United States
• Memorial Sloan Kettering Suffolk - Commack (Consent Only) — Commack, New York, United States
• Memorial Sloan Kettering Westchester (Consent Only) — Harrison, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Memorial Sloan Kettering Nassau (Consent Only) — Uniondale, New York, United States
• Lehigh Valley Health Network (Dara Collection Only) — Allentown, Pennsylvania, United States

Full record on ClinicalTrials.gov

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