Omission of SLNB in CN0 Early Breast Cancer

Launched by THE FIRST AFFILIATED HOSPITAL WITH NANJING MEDICAL UNIVERSITY · Jul 4, 2023

Keywords

ClinConnect Summary

The OMSLNB trial is studying whether some women with early-stage breast cancer can safely avoid a specific type of surgery called sentinel lymph node biopsy (SLNB). This surgery is usually done to check if cancer has spread to the lymph nodes. In this trial, eligible participants are women aged 18 to 70 who have a confirmed diagnosis of invasive breast cancer with a tumor size of 3 cm or smaller and show no signs of cancer in their lymph nodes based on imaging tests. Instead of having the SLNB, these women will undergo breast surgery, which may include options like breast-conserving surgery.

Participants in this trial can expect to have a thorough evaluation, including multiple imaging tests, to ensure their axillary lymph nodes are negative for cancer before proceeding. The goal of the study is to reduce the risk of complications and improve the quality of life for patients by avoiding unnecessary surgeries. It's important to note that this trial is currently recruiting participants and aims to provide valuable insights into treatment options for early breast cancer.

Gender

FEMALE

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.