Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Clinically Assessed Negative Axillary Lymph Nodes | — | UNRESOLVED | — |
| Sentinel Lymph Node | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Omit SLNB | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- OMSLNB
- interventionNames
- Procedure: Omit SLNB
Primary outcomes (1)
- measure
- invasive Disease-Free Survival (iDFS)
- timeFrame
- 3 years
- description
- Time interval from the surgery to invasive local-regional recurrence, distant metastasis, contralateral invasive breast cancer, or death from any cause.
Secondary outcomes (5)
- measure
- Breast cancer-related lymphoedema (BCRL)
- timeFrame
- 3 years
- description
- Objective evaluation of breast cancer-related lymphoedema (BCRL) by arm circumference measurements and bioelectrical impedance technology. In our study, BCRL is diagnosed in two ways：① Relative Volume Change (RVC ) \>10% in the affected upper extremity. ②Bioelectrical impedance technology: the impedance ratio is defined as the ratio of the impedance of the healthy upper limb to the impedance of the affected upper limb, and BCRL is diagnosed when the patient's impedance ratio is higher than the mean + 2 standard deviations (SD) of healthy controls, and BCRL will be diagnosed by meeting one of them.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Female patients aged 18-70 years; 2. Pathologically confirmed invasive breast cancer (regardless of pathological type) with a tumor diameter ≤ 3 cm, and planning to undergo breast surgery; 3. 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); 4. 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; 5. Good compliance, normal comprehension and ability to receive treatment and follow-up as required; 6. ECOG score 0-1; 7. Patients volunteered for this study and signed the informed consent form. Exclusion Criteria: 1. Bilateral/lactating/pregnant breast cancer; 2. Previous history of malignant tumor or neoplasm; 3. Clinical or imaging confirmation of distant metastasis; 4. History of previous surgery on the affected axilla; or history of surgery affecting the function of the upper extremity; 5. Prior history of radiotherapy to the breast or chest; 6. Positive pathological margins after breast-conserving surgery or mastectomy; 7. Severe coagulation disorder, or a serious systemic disease, or an uncontrollable infection; 8. 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; 9. Inability to complete the full course of follow-up adjuvant therapy as prescribed by the doctor for various reasons; 10. No personal freedom and independent civil capacity; 11. Presence of mental disorders, addictions, etc; 12. Not eligible for enrollmentas as judged by the investigator.
References
Publications (1)
- DERIVEDLi 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