Clinical trial · Observational
Use of Sentinel Lymph Node Biopsy in Patients With Early-Stage, Palpable Node-Positive HR+/HER2- Breast Cancer Having Upfront Surgery and Adjuvant Radiation
Selective Use of ALND in N1 HR+/HER2- Breast Cancer Patients With 1 or 2 Positive Sentinel Lymph Nodes Undergoing Upfront Breast Surgery and Adjuvant Radiation: A Prospective Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Breast surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Breast Cancer
- description
- Patients with cTx/cT1-2cN1 HR+/HER2- tumors who are scheduled to undergo upfront surgery will undergo AUS at the enrolling institution to characterize suspicious-appearing lymph nodes, as is part of routine practice.
- interventionNames
- Procedure: Breast surgery
Primary outcomes (1)
- measure
- evaluate rates of axillary lymph node dissection
- timeFrame
- 2 years
- description
- Completion ALND will be required if metastases are present in ≥3 SLNs on pathologic evaluation.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (1)
- DERIVEDMamtani A, Pilewskie M, Wilson N, Chung Whang H, Barrio AV, Bassin L, Capko D, Choi DX, Cody HS 3rd, Downs-Canner S, El-Tamer M, Gemignani ML, Heerdt AS, Kirstein L, Lee MK, Mango VL, Montagna G, Moo TA, Oxenberg J, Plitas G, Sabel M, Sacchini V, Sclafani L, Sevilimedu V, Tadros AB, Van Zee KJ, Morrow M. Sentinel Lymph Node Biopsy for Patients With cN1 HR+/HER2- Breast Cancer and Palpable Adenopathy: A Nonrandomized Clinical Trial. JAMA Surg. 2026 Jul 1;161(7):662-668. doi: 10.1001/jamasurg.2026.1268. PMID 42090164