Use of Sentinel Lymph Node Biopsy in Patients With Early-Stage, Palpable Node-Positive HR+/HER2- Breast Cancer Having Upfront Surgery and Adjuvant Radiation

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04854005
• Other study ID #: 21-183
• Status: Recruiting
• Start date: April 20, 2021
• Est. completion date: April 2025

Study information

• Verified date: February 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Anita Mamtani, MD
• Phone: 646-888-6864
• Email: mamtana1[@]mskcc.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 78
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• Breast surgery
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.

Locations

Country	Name	City	State
United States	Lehigh Valley Health Network (Dara Collection Only)	Allentown	Pennsylvania
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 Suffolk - Commack (Consent Only)	Commack	New York
United States	Memorial Sloan Kettering Westchester (Consent Only)	Harrison	New York
United States	Hartford Healthcare Cancer Alliance (Data collection only)	Hartford	Connecticut
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 Cancer Center	New York	New York
United States	Memorial Sloan Kettering Nassau (Consent Only)	Uniondale	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	evaluate rates of axillary lymph node dissection	Completion ALND will be required if metastases are present in =3 SLNs on pathologic evaluation.	2 years

External Links

•   Memorial Sloan Kettering Cancer Center