Actively Recruiting
Omission of SLNB in CN0 Early Breast Cancer
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2024-10-15
311
Participants Needed
1
Research Sites
223 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Omission of SLNB in CN0 Early Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18-70 years
- Pathologically confirmed invasive breast cancer with tumor diameter 64 3 cm
- Negative axillary lymph nodes by physical exam and at least two imaging tests including ultrasound, MRI, PET-CT, or PET-MRI
- Immunohistochemical staining for ER, PR, HER2, Ki-67, and FISH for HER2 2+ cases
- Good compliance and ability to undergo treatment and follow-up
- ECOG performance status of 0-1
- Voluntary participation with signed informed consent form
You will not qualify if you...
- Bilateral, lactating, or pregnant breast cancer
- Previous malignant tumor or neoplasm
- Distant metastasis confirmed clinically or by imaging
- Previous surgery on the affected axilla or upper extremity
- Prior radiotherapy to the breast or chest
- Positive pathological margins after breast surgery
- Severe coagulation disorder, serious systemic disease, or uncontrolled infection
- Elevated liver enzymes, alkaline phosphatase, bilirubin, creatinine beyond specified limits; left ventricular ejection fraction below 50%
- Inability to complete prescribed follow-up therapy
- Lack of personal freedom or independent civil capacity
- Presence of mental disorders or addictions
- Determined ineligible by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
the First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Actively Recruiting
Research Team
J
Jue Wang, MD
CONTACT
X
Xuan Li, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here