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

Memorial Sloan Kettering Cancer Center (MSK)

Status: Active, not recruiting

Conditions: Breast Cancer

Treatments: Procedure: Breast surgery

Study type: Observational

Funder types: Other

Identifiers

NCT04854005

21-183

Details and patient eligibility

About

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.

Enrollment: 78 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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)

Trial design

78 participants in 1 patient group

Breast Cancer

Description:

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.

Treatment:

Procedure: Breast surgery