Omission of SLNB in cN0 Early Breast Cancer

Study Overview
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Brief Summary
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OMSLNB is a prospective, non-inferiority, single-arm clinical trial designed to omit sentinel lymph node biopsy in patients with clinically assessed negative axillary lymph nodes early breast cancer (tumor<3cm) to decrease the edema of upper arm, and finally improve the quality of life of the patients. Patients enrolled must have had 2 or more of the following radiographic examinations, including ultrasound, breast MRI, breast PET-CT, breast PET-MRI, breast PET-MRI and be diagnosed as axillary lymph nodes negative, and be planning to undergo breast surgery. Types of breast surgery are not limited to breast-conserving surgery.

Official Title
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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

Conditions
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Breast Cancer, Sentinel Lymph Node, Clinically Assessed Negative Axillary Lymph Nodes

Intervention / Treatment
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* Procedure: Omit SLNB


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OMSLNB<br> | Procedure: Omit SLNB<br>* Omit SLNB in cN0 EBC patients. All patients enrolled have to receive two or more of the following radiographic examinations including ultrasound, breast MRI, breast PET-CT, breast PET-MRI, and breast PET.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| invasive Disease-Free Survival (iDFS) | Time interval from the surgery to invasive local-regional recurrence, distant metastasis, contralateral invasive breast cancer, or death from any cause. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breast cancer-related lymphoedema (BCRL) | 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. When the two measurements are inconsistent, the former results shall prevail. | 3 years | 
| Quality of life (QoL) | Patients' subjective assessment of quality of life (QoL) using the Functional Assessment of Cancer Therapy-Breast (FACT-B) . FACT-B is divided into 36 items in 5 domains, namely: physical status (7 items), social/family status (7 items), emotional status (6 items), functional status (7 items) and additional concerns, and each item is classified into five levels: not at all (0), somewhat (1), somewhat (2), fairly (3) and very much (4). Positive items were scored directly from 0 to 4, while negative items (i.e., the larger the number of response options, the worse the quality of life) were scored in reverse. The total score of FACT-B scale ranges from 0 to 144, a higher score means a better quality of life for the patient. | 3 years | 
| Patient-reported arm morbidity | Patients' subjective assessment of lymphedema using the Quick Disability of the Arm, Shoulder, and Hand (Quick DASH) questionnaires，Quick DASH consists of 11 items, and is a self-rating scale of daily functioning including social functioning and physical activity and upper extremity symptoms. Each item is divided into 5 levels, and the patient's score is calculated as score = [(patient score/number of response items) - 1] × 25, with a total score of 0 to 100, and the higher the score, the greater the degree of upper limb dysfunction. | 3 years | 
| Locoregional Recurrence (LRR) | This includes both local and regional recurrences. Local recurrence is defined as recurrence in the ipsilateral breast, chest wall, skin or surgical scar. Regional recurrence is defined as recurrence in the affected lymphatic drainage area, including the axilla, supraclavicular region, subclavicular region, and internal mammary node area. | 3 years | 
| Local Recurrence (LR) | Local recurrence is defined as recurrence in the ipsilateral breast, chest wall, skin or surgical scar. | 3 years | 
| Regional Recurrence (RR) | Regional recurrence is defined as recurrence in the affected lymphatic drainage area, including the axilla, supraclavicular region, subclavicular region, and internal mammary node area. | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, clinically assessed negative axillary lymph nodes, sentinel lymph node biopsy