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 (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:
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 10 Locations for this study
Hartford Connecticut, 06102, United States More Info
Basking Ridge New Jersey, 07920, United States More Info
Middletown New Jersey, 07748, United States More Info
Commack New York, 11725, United States More Info
Harrison New York, 10604, 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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