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

Active, not recruiting

• Conditions: Breast Cancer
• Interventions: Procedure: Breast surgery

• Registration Number: NCT04854005
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-20
• Study First Submitted: 2021-04-20
• Study First Submitted QC: 2021-04-20
• Study First Posted: 2021-04-22
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-01
• Last Update Posted: 2025-05-06
• Primary Completion: 2026-04
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 78

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Breast Cancer	Breast surgery	Patients with cTx/cT1-2cN1 HR+/HER2- tumors who are scheduled to undergo upfront surgery will undergo AUS at the enrolling institution to characterize suspicious-appearing lymph nodes, as is part of routine practice.

Primary Outcome Measures

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

Trial Locations

Locations (10)

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