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Recruiting NCT05935150

Omission of SLNB in CN0 Early Breast Cancer

No phase Interventional Breast Cancer Clinically Assessed Negative Axillary Lymph Nodes Sentinel Lymph Node

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Omit SLNB.
Who it may be relevant to
Registry conditions: Breast Cancer, Clinically Assessed Negative Axillary Lymph Nodes, Sentinel Lymph Node. Basic parameters: 18 years — 70 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Procedure Omit 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 radiother

Primary outcome measures

  • invasive Disease-Free Survival (iDFS) [Time frame: 3 years]
Secondary outcome measures (5)
  • Breast cancer-related lymphoedema (BCRL) [Time frame: 3 years]
  • Patient-reported outcomes (PROs) [Time frame: 3 years]
  • Locoregional Recurrence (LRR) [Time frame: 3 years]
  • Local Recurrence (LR) [Time frame: 3 years]
  • Regional Recurrence (RR) [Time frame: 3 years]

Eligibility criteria

Inclusion criteria

  • Female patients aged 18-70 years;
  • Pathologically confirmed invasive breast cancer (regardless of pathological type) with a tumor diameter ≤ 3 cm, and planning to undergo breast surgery;
  • Negative axillary lymph nodes assessed by physical examination and imaging (2 or more of the following tests including ultrasound, breast MRI, breast PET-CT, breast PET-MRI, breast PET);
  • All patients are required to undergo immunohistochemical staining for Estrogen Receptor (ER), Progesterone Receptor (PR), human epidermal growth factor receptor 2 (HER2), Ki-67 proliferation index, and further fluorescence in situ hybridization (FISH) should be performed in HER2 2+ cases;
  • Good compliance, normal comprehension and ability to receive treatment and follow-up as required;
  • ECOG score 0-1;
  • Patients volunteered for this study and signed the informed consent form.

Exclusion criteria

  • Bilateral/lactating/pregnant breast cancer;
  • Previous history of malignant tumor or neoplasm;
  • Clinical or imaging confirmation of distant metastasis;
  • History of previous surgery on the affected axilla; or history of surgery affecting the function of the upper extremity;
  • Prior history of radiotherapy to the breast or chest;
  • Positive pathological margins after breast-conserving surgery or mastectomy;
  • Severe coagulation disorder, or a serious systemic disease, or an uncontrollable infection;
  • Aspartate aminortransferse (AST) and Alanine aminotransferase (ALT) ≥ 1.5 times the upper limit of normal, alkaline phosphatase ≥ 2.5 times the upper limit of normal, total bilirubin ≥ 1.5 times the upper limit of normal, serum creatinine ≥ 1.5 times the upper limit of normal; left ventricular injection fraction (LVEF) < 50% on cardiac ultrasound;
  • Inability to complete the full course of follow-up adjuvant therapy as prescribed by the doctor for various reasons;
  • No personal freedom and independent civil capacity;
  • Presence of mental disorders, addictions, etc;
  • Not eligible for enrollmentas as judged by the investigator.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • the First Affiliated Hospital of Nanjing Medical University — Nanjing

Publications

  • Li X, Wang L, Wang Y, Ma L, Zheng R, Ding J, Gong Y, Yao H, Wang J, Zha X. Omission of sentinel lymph node biopsy in patients with clinically axillary lymph node-negative early breast cancer (OMSLNB): protocol for a prospective, non-inferiority, single-arm, phase II clinical trial in China. BMJ Open. 2024 Sep 10;14(9):e087700. doi: 10.1136/bmjopen-2024-087700. PMID 39260835

Identifiers

NCT: NCT05935150 · OMSLNB

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗