RecruitingNot ApplicableNCT05935150

Omission of SLNB in CN0 Early Breast Cancer

Omission of Sentinel Lymph Node Biopsy (SLNB ) in Early Breast Cancer Patients with Clinically Assessed Negative Axillary Lymph Nodes (cN0): a Phase II, Prospective Clinical Trial

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Enrollment

311 participants

Start Date

Jun 21, 2023

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Sentinel Lymph Node Clinically Assessed Negative Axillary Lymph Nodes

Summary

The OMSLNB trial adopts a prospective, single-arm, non-inferiority, phase-II, open-label study design. Patients with unilateral invasive breast cancer （tumor ≤3cm） and assessed as cN0 will be eligible for inclusion, enrolled patients are required to complete 2 or more imaging tests including axillary ultrasound assessed as axillary lymph node negative, and other tests including MRI, PET-CT, \[18F\]-FDG PET-MRI, eligible patients will avoid axillary surgery but will undergo breast surgery, which is not limited to breast-conserving surgery (BCS). So as to decrease the edema of upper arm, and finally improve the quality of life of the patients.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether women with early-stage breast cancer who have no cancer detected in their underarm (axillary) lymph nodes can safely skip the sentinel lymph node biopsy (a procedure that removes and tests a lymph node during breast surgery) without affecting their treatment outcomes. **You may be eligible if...** - You are a woman aged 18–70 - You have been diagnosed with invasive breast cancer with a tumor no larger than 3 cm - Imaging (ultrasound, MRI, or PET scan) and physical exam show no cancer in your underarm lymph nodes - Your tumor has been tested for hormone receptors (ER, PR), HER2, and cell growth markers (Ki-67) - You are planning to have breast surgery **You may NOT be eligible if...** - Your tumor is larger than 3 cm - Imaging shows suspicious lymph nodes - You have not had the required tumor marker tests - You have other conditions that would affect your ability to complete the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREOmit SLNB

All patients enrolled have to receive two or more imaging tests including axillary ultrasound assessed as axillary lymph node negative, and other tests including MRI, PET-CT, \[18F\]-FDG PET-MRI, axillary surgery will be omitted for eligible patients, and BCS or mastectomy (allowing breast reconstruction) will be chosen voluntarily by the patient under the premise of ensuring therapeutic efficacy, patients receiving BCS must undergo whole breast irradiation (WBI) after surgery, and the radiotherapy target area does not include the axillary region.

Locations(1)

the First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

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NCT05935150

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