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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Sentinel Lymph Node; Clinically Assessed Negative Axillary Lymph Nodes
• Intervention / Treatment: Procedure: Omit SLNB

• Study Type: Interventional
• Enrollment (Estimated): 311
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jue Wang, MD; Phone Number: 025-68306360; Email: wangjue200011@njmu.edu.cn
• Study Contact Backup: Name: Xuan Li, MD; Phone Number: 18154489540; Email: lixuan1204@stu.njmu.edu.cn

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Recruiting
      • The First Affiliated Hospital of Nanjing Medical University
      • Contact: Jue Wang, MD; Phone Number: 025-68306360; Email: wangjue200011@njmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: OMSLNB

Procedure: Omit SLNB; All patients enrolled have to receive two or more imaging tests including axillary ultrasound assessed as axillary lymph node negative, and other tests including MRI, PET-CT, [18F]-FDG PET-MRI, axillary surgery will be omitted for eligible patients, and BCS or mastectomy (allowing breast reconstruction) will be chosen voluntarily by the patient under the premise of ensuring therapeutic efficacy, patients receiving BCS must undergo whole breast irradiation (WBI) after surgery, and the radiotherapy target area does not include the axillary region.

What is the study measuring?

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
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
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, and BCRL will be diagnosed by meeting one of them.	3 years
Patient-reported outcomes (PROs)	Patients will be followed up with questionnaires using the FACT-B (Version 4.0) and Quick DASH at baseline, 1 week, 1, 3, 6, 12, 18, 24, and 36 months postoperatively, and the FACT-B scale will be used to assess changes in QoL from baseline to 3 years after surgery, and the Quick DASH scale will be used to assess changes in arm morbidity from baseline to 3 years after surgery.	3 years

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University
• Investigators: Principal Investigator: Xiaoming Zha, MD, The First Affiliated Hospital with Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2023
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: June 2, 2023
• First Submitted That Met QC Criteria: July 4, 2023
• First Posted (Actual): July 7, 2023

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 11, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: breast cancer; sentinel lymph node biopsy; clinically assessed negative axillary lymph nodes
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: OMSLNB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No