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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Page 1 of 1 (1 locations)

1

Ruijin hospital, Shanghai jiaotong university school of medicine

Shanghai, China, China, 200025