Omission of SLNB in CN0 Early Breast Cancer
Recruiting · NCT05935150 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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.
Where it is running
1 location listed.
- the First Affiliated Hospital of Nanjing Medical University - Nanjing, Jiangsu, China