Status:
ACTIVE_NOT_RECRUITING
Use of Sentinel Lymph Node Biopsy in Patients With Early-Stage, Palpable Node-Positive HR+/HER2- Breast Cancer Having Upfront Surgery and Adjuvant Radiation
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Brief 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 resea...
Eligibility Criteria
Inclusion
- 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:
- 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
- Patients with prior ipsilateral breast cancer
- Patients who are pregnant
- Patients with stage IV disease at presentation
- Patients with advanced regional disease (cN2/cN3)
Key Trial Info
Start Date :
April 20 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT04854005
Start Date
April 20 2021
End Date
April 1 2026
Last Update
May 6 2025
Active Locations (10)
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1
Hartford Healthcare Cancer Alliance (Data collection only)
Hartford, Connecticut, United States, 06102
2
University of Michigan (Data Collection Only)
Ann Arbor, Michigan, United States, 48109
3
Memorial Sloan Kettering Basking Ridge (Consent Only)
Basking Ridge, New Jersey, United States, 07920
4
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, United States, 07748