Breast Cancer Clinical Trial

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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.

View Eligibility Criteria

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

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Hartford Healthcare Cancer Alliance (Data collection only)
Hartford Connecticut, 06102, United States More Info

Niamey Wilson, MD
Contact
203-694-5200

University of Michigan
Ann Arbor Michigan, 48109, United States More Info

Melissa Pilewskie, MD
Contact
734-647-8902

Memorial Sloan Kettering Basking Ridge (Consent Only)
Basking Ridge New Jersey, 07920, United States More Info