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

Last updated: October 1, 2024
Sponsor: Memorial Sloan Kettering Cancer Center
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Cancer

Breast Cancer

Treatment

Breast surgery

Clinical Study ID

NCT04854005
21-183
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients aged ≥18 years with biopsy-proven invasive breast cancer

  • Patients with cTx, cT1, or cT2 tumors with palpable ipsilateral mobile adenopathy oflevel I/II axillary nodes with biopsy-proven (either by pre-operative biopsy orintraoperative frozen section) nodal metastasis (cN1) who are undergoing upfrontsurgery

  • 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% oftumor cells (IHC 0 or 1+) or negative by dual probe in situ hybridization assay

Exclusion

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

Total Participants: 78
Treatment Group(s): 1
Primary Treatment: Breast surgery
Phase:
Study Start date:
April 20, 2021
Estimated Completion Date:
April 30, 2025

Connect with a study center

  • Hartford Healthcare Cancer Alliance (Data collection only)

    Hartford, Connecticut 06102
    United States

    Site Not Available

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • University of Michigan (Data Collection Only)

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Memorial Sloan Kettering Basking Ridge (Consent Only)

    Basking Ridge, New Jersey 07920
    United States

    Site Not Available

  • Memorial Sloan Kettering Monmouth (All Protocol Activities)

    Middletown, New Jersey 07748
    United States

    Site Not Available

  • Memorial Sloan Kettering Bergen (Consent Only)

    Montvale, New Jersey 07645
    United States

    Site Not Available

  • Memorial Sloan Kettering Suffolk - Commack (Consent Only)

    Commack, New York 11725
    United States

    Site Not Available

  • Memorial Sloan Kettering Westchester (Consent Only)

    Harrison, New York 10604
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Site Not Available

  • Memorial Sloan Kettering Nassau (Consent Only)

    Uniondale, New York 11553
    United States

    Site Not Available

  • Memorial Sloan Kettering Westchester (Consent Only)

    West Harrison, New York 10604
    United States

    Site Not Available

  • Lehigh Valley Health Network (Dara Collection Only)

    Allentown, Pennsylvania 18103
    United States

    Site Not Available

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