Breast Cancer Clinical Trial
Use of Sentinel Lymph Node Biopsy in Patients With Early-Stage, Palpable Node-Positive HR+/HER2- Breast Cancer Having Upfront Surgery and Adjuvant Radiation
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 only 1 or 2 affected lymph nodes, it will be possible to perform the less radical standard SLNB during surgery.
Eligibility Criteria
Inclusion Criteria:
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)
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There are 3 Locations for this study
Middletown New Jersey, 07748, United States More Info
New York New York, 10065, United States More Info
Principal Investigator
Allentown Pennsylvania, 18103, United States More Info
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