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)
Doctor(s) Running This Study

Accepting New Patients

Specialties
Surgical Oncology
Area of focus
Breast cancers
Benign disorders of the breast
Thyroid cancer
LVHN Affiliates
Lehigh Valley Topper Cancer Institute
Lehigh Valley Institute for Surgical Excellence
Locations

1240 S Cedar Crest Blvd
Suite 410
Allentown, PA 18103-6264
United States

2545 Schoenersville Road
Third Floor
Bethlehem, PA 18017-7300
United States