Omission of SLNB in CN0 Early Breast Cancer

Trial Title: Omission of SLNB in CN0 Early Breast Cancer

NCT ID: NCT05935150

Condition: Breast Cancer
Clinically Assessed Negative Axillary Lymph Nodes
Sentinel Lymph Node

Conditions: Official terms:
Breast Neoplasms

Conditions: Keywords:
breast cancer
clinically assessed negative axillary lymph nodes
sentinel lymph node biopsy

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Procedure
Intervention name: Omit SLNB
Description: 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.
Arm group label: OMSLNB

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.

Criteria for 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.

Gender: Female

Minimum age: 18 Years

Maximum age: 70 Years

Healthy volunteers: No

Locations:

Facility:
Name: the First Affiliated Hospital of Nanjing Medical University

Address:
City: Nanjing
Country: China

Status: Recruiting

Contact:
Last name: Jue Wang, MD

Phone: 025-68306360
Email: wangjue200011@njmu.edu.cn

Start date: June 21, 2023

Completion date: October 1, 2027

Lead sponsor:
Agency: The First Affiliated Hospital with Nanjing Medical University
Agency class: Other

Source: The First Affiliated Hospital with Nanjing Medical University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05935150