Avoiding sentinel lymph node biopsy in early breast cancer patients
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
This study is testing whether women with early breast cancer can safely skip a specific lymph node surgery to see if it helps them recover better and have less swelling in their arms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 311 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT05935150 on ClinicalTrials.gov |
What this trial studies
The OMSLNB trial is a prospective, single-arm, non-inferiority study designed for female patients with unilateral invasive breast cancer and clinically assessed negative axillary lymph nodes. Eligible participants will undergo imaging tests to confirm the absence of lymph node involvement and will proceed with breast surgery without sentinel lymph node biopsy. This approach aims to reduce upper arm edema and enhance the quality of life for patients post-surgery.
Who should consider this trial
Good fit: Ideal candidates are female patients aged 18-70 with pathologically confirmed invasive breast cancer and negative axillary lymph nodes.
Not a fit: Patients with bilateral breast cancer, those who are pregnant or lactating, or those with a history of malignant tumors may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help reduce unnecessary surgical procedures and improve the quality of life for breast cancer patients.
How similar studies have performed: While this approach is innovative, similar studies have not been widely reported, indicating a novel exploration in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Nanjing, Jiangsu
- the First Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Principal investigator: Xiaoming Zha, MD — The First Affiliated Hospital with Nanjing Medical University
- Study coordinator: Jue Wang, MD
- Email: wangjue200011@njmu.edu.cn
- Phone: 025-68306360
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.