Status:
ACTIVE_NOT_RECRUITING
Precision Regional Node Irradiation for Sentinel Node-positive Breast Cancer
Lead Sponsor:
Ruijin Hospital
Conditions:
Breast Cancer Invasive
Eligibility:
FEMALE
18-80 years
Phase:
NA
Brief Summary
Axillary lymph node dissection has long been regarded as standard if treatment of the axilla is indicated for patients with a positive sentinel node. Although axillary lymph node dissection provides e...
Eligibility Criteria
Inclusion
- 1\. Histologically confirmed invasive breast cancer; 2. Age between 18 and 80 years; 3. cN0 breast cancer underwent radical surgery combined with Sentinel Lymph Node Dissection (SLND) alone with SLND positive or SLND and axillary lymph node dissection (ALND) with positive lymph node metastasis; 4. for SLND alone cohort, the regional lymph node irradiation area was determined according to the clinical risk model and genomic risk model assessment; 5. Ability to understand and willingness to participate the research and sign the consent form
Exclusion
- • Pathologically positive ipsilateral supraclavicular lymph node
- Pathologically or radiologically confirmed involvement of ipsilateral internal mammary lymph nodes;
- Pregnant or lactating women;
- Insulin dependent diabetes;
- History of non-breast malignancy within 5 years with the exception of lobular carcinoma in situ, basal cell carcinoma of the skin, carcinoma in situ of skin and carcinoma in situ of the cervix;
- patients have simultaneous contralateral breast cancer;
- clinical diagnosis of distant metastatic disease;
- Previous radiotherapy to the neck, chest and/or ipsilateral axillary region
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
205 Patients enrolled
Trial Details
Trial ID
NCT06583655
Start Date
October 1 2024
End Date
June 30 2026
Last Update
July 31 2025
Active Locations (1)
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1
Ruijin hospital, Shanghai jiaotong university school of medicine
Shanghai, China, China, 200025