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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breast Cancer | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| evaluate rates of axillary lymph node dissection | Completion ALND will be required if metastases are present in ≥3 SLNs on pathologic evaluation. | 2 years |
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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:
Exclusion Criteria:
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Potential research subjects will be identified by a member of the patient's treatment team, the Principal Investigator (PI), or the research team at MSKCC/participating institutions.
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| Name | Affiliation | Role |
|---|---|---|
| Anita Mamtani, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hartford Healthcare Cancer Alliance (Data collection only) | Hartford | Connecticut | 06102 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42090164 | Derived | 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 May 6:e261268. doi: 10.1001/jamasurg.2026.1268. Online ahead of print. |
| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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| University of Michigan (Data Collection Only) |
| Ann Arbor |
| Michigan |
| 48109 |
| United States |
| Memorial Sloan Kettering Basking Ridge (Consent Only) | Basking Ridge | New Jersey | 07920 | United States |
| Memorial Sloan Kettering Monmouth (All Protocol Activities) | Middletown | New Jersey | 07748 | United States |
| Memorial Sloan Kettering Bergen (Consent Only) | Montvale | New Jersey | 07645 | United States |
| Memorial Sloan Kettering Suffolk - Commack (Consent Only) | Commack | New York | 11725 | United States |
| Memorial Sloan Kettering Westchester (Consent Only) | Harrison | New York | 10604 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Memorial Sloan Kettering Nassau (Consent Only) | Uniondale | New York | 11553 | United States |
| Lehigh Valley Health Network (Dara Collection Only) | Allentown | Pennsylvania | 18103 | United States |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D015412 | Mastectomy, Segmental |
| ID | Term |
|---|---|
| D008408 | Mastectomy |
| D013514 | Surgical Procedures, Operative |
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