Randomized Study of Elective Regional Lymph Node Irradiation in N1 Breast Cancer
- Conditions
- Neoplasms
- Registration Number
- KCT0002488
- Lead Sponsor
- Samsung Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 1926
Histologically proven invasive carcinoma of the breast.
-One to three positive axillary lymph nodes (pN1) proven in pathologic specimen.
-Prior breast-conserving surgery and post-operative adjuvant chemotherapy including anthracycline and taxane.
-Administering adjuvant hormonal therapy in cases with hormone receptor-positive tumor.
-Administering anti-HER2 therapy in cases with HER2-positive tumor.
Metastases in supraclavicular or internal mammary lymph nodes.
-Metastases in distant organs.
-Neoadjuvant chemotherapy or hormone therapy before surgery.
-Not receiving adjuvant anthracycline and taxane.
-Bilateral breast cancer
-Previous history of radiotherapy of the ipsilateral breast or supraclavicular lymph nodes.
-Prior history of other types of cancer, except thyroid cancer, carcinoma in situ of the cervix, or skin cancer.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disease-free survival
- Secondary Outcome Measures
Name Time Method Disease-free survival according to molecular subtype;Treatment-related toxicity;Quality of life