Clinical Trial: Breast Cancer, Cancer

MSK 21-183 Breast Cancer

Full Name

Selective Use of ALND in cT1-2N1 HR+/HER2- Breast Cancer Patients with 1 or 2 Positive Sentinel Lymph Nodes Undergoing Upfront Surgery and Adjuvant Radiation: A Prospective Study

Description

The purpose of this study is to find out how often the researchers can avoid an ALND in women 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 only 1 or 2 affected lymph nodes, it will be possible to perform the less radical standard SLNB during surgery.

Eligibility

Inclusion Criteria
  • Female patients aged ≥18 years with biopsy-proven invasive breast cancer
  • Patients with cT1 or T2 tumors with palpable ipsilateral mobile adenopathy of level I/II axillary nodes with biopsy-proven 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 occult primary breast cancer
  • Patients with prior ipsilateral breast cancer
  • Patients who are pregnant
  • Patients with stage IV disease at presentation
  • Patients with advanced regional disease (cN2/cN3)