Omission of SLNB in CN0 Early Breast Cancer (NCT05935150) | Clinical Trial Compass
RecruitingNot Applicable
Omission of SLNB in CN0 Early Breast Cancer
China311 participantsStarted 2023-06-21
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexFEMALE
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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;
What they're measuring
1
invasive Disease-Free Survival (iDFS)
Timeframe: 3 years
Trial details
NCT IDNCT05935150
SponsorThe First Affiliated Hospital with Nanjing Medical University
✕. 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;