Clinical trial NCT05935150: Omission of SLNB in CN0 Early Breast Cancer
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Clinically Assessed Negative Axillary Lymph Nodes
Sentinel Lymph Node
Keywords: breast cancer
clinically assessed negative axillary lymph nodes
sentinel lymph node biopsy
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2023-07-07
Enrollment: 311
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 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.

Primary outcomes:
measure: invasive Disease-Free Survival (iDFS)
timeFrame: 3 years
Secondary outcomes:
measure: Breast cancer-related lymphoedema (BCRL)
timeFrame: 3 years
measure: Patient-reported outcomes (PROs)
timeFrame: 3 years
measure: Locoregional Recurrence (LRR)
timeFrame: 3 years
measure: Local Recurrence (LR)
timeFrame: 3 years
measure: Regional Recurrence (RR)
timeFrame: 3 years
Other outcomes:
Locations:
city: Nanjing
country: China
facility: the First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Xiaoming Zha, MD
role: PRINCIPAL_INVESTIGATOR
References: