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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

NCT04854005

Active Not RecruitingN/A

Sponsor: Memorial Sloan Kettering Cancer Center

Conditions: Breast Cancer

Interventions: Breast surgery

Countries: United States

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 up to 3 affected lymph nodes, it will be possible to perform the less radical standard SLNB during surgery.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

* Patients aged ≥18 years with biopsy-proven invasive breast cancer
* Patients with cTx, cT1, or cT2 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:

  1. HR+: Positive for estrogen receptor and/or progesterone receptor staining, indicated by ≥1% immunoreactive tumor nuclei
  2. 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 prior ipsilateral breast cancer
* Patients who are pregnant
* Patients with stage IV disease at presentation
* Patients with advanced regional disease (cN2/cN3)

Locations (10)

Hartford, Connecticut, United States
Ann Arbor, Michigan, United States
Basking Ridge, New Jersey, United States
Middletown, New Jersey, United States
Montvale, New Jersey, United States
Commack, New York, United States
Harrison, New York, United States
New York, New York, United States
Uniondale, New York, United States
Allentown, Pennsylvania, United States