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 recruiting, 78 participants, Memorial Sloan Kettering Cancer Center

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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

Registry	NCT04854005
Status	Active not recruiting
Study type	Observational
Enrollment	78 (Estimated)
Sponsor	Memorial Sloan Kettering Cancer Center (Other)
Conditions	Breast Cancer
Interventions	Breast surgery (Procedure)
Dates	start 2021-05-20, primary completion 2027-04-01 (estimated), completion 2027-04-01 (estimated), first posted 2021-04-22, last updated 2026-08-03
Locations	10 sites in United States

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

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+Arms and interventions

Arm	Type	Interventions	Description
Breast Cancer		Procedure: Breast surgery	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.

Breast surgery (Procedure): Patients will undergo SLNB with single or dual-tracer lymphatic with technetium-99m sulfur colloid either lymphazurin or methylene blue dye, per institution standard, in accordance with routine clinical practice.

+Outcome measures

Primary outcomes

evaluate rates of axillary lymph node dissection [2 years]: Completion ALND will be required if metastases are present in ≥3 SLNs on pathologic evaluation.

+Eligibility

Sex: All, ages: 18 Years to any

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)

Facility	City	Country
Hartford Healthcare Cancer Alliance (Data collection only)	Hartford, Connecticut	United States
University of Michigan (Data Collection Only)	Ann Arbor, Michigan	United States
Memorial Sloan Kettering Basking Ridge (Consent Only)	Basking Ridge, New Jersey	United States
Memorial Sloan Kettering Monmouth (All Protocol Activities)	Middletown, New Jersey	United States
Memorial Sloan Kettering Bergen (Consent Only)	Montvale, New Jersey	United States
Memorial Sloan Kettering Suffolk - Commack (Consent Only)	Commack, New York	United States
Memorial Sloan Kettering Westchester (Consent Only)	Harrison, New York	United States
Memorial Sloan Kettering Cancer Center	New York, New York	United States
Memorial Sloan Kettering Nassau (Consent Only)	Uniondale, New York	United States
Lehigh Valley Health Network (Dara Collection Only)	Allentown, Pennsylvania	United States

+Publications

Results publication: Mamtani 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

+Investigators

Anita Mamtani, MD, Principal investigator, Memorial Sloan Kettering Cancer Center