Status:
ACTIVE_NOT_RECRUITING
Randomized Study of Elective Regional Lymph Node Irradiation in N1 Breast Cancer
Lead Sponsor:
Samsung Medical Center
Collaborating Sponsors:
Korean Radiation Oncology Group
Ministry of Health, Republic of Korea
Conditions:
Breast Neoplasm
Eligibility:
FEMALE
20-70 years
Phase:
NA
Brief Summary
This study evaluates the impact of elective regional lymph node irradiation on N1 breast cancer patients receiving post-lumpectomy radiotherapy and anthracycline plus taxane (AT)-based chemotherapy. W...
Detailed Description
Objective: * Compare the effect of post-BCS WBI vs. WB+RNI on disease-free survival in pN1 breast cancer patients who received AT-based chemotherapy. * Evaluate the impact of WBI or WB+RNI according ...
Eligibility Criteria
Inclusion
- 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 taxane.
- Administering adjuvant hormonal therapy in cases with hormone receptor-positive tumor.
- Administering anti-HER2 therapy in cases with HER2-positive tumor.
Exclusion
- 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.
Key Trial Info
Start Date :
April 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2029
Estimated Enrollment :
827 Patients enrolled
Trial Details
Trial ID
NCT03269981
Start Date
April 1 2017
End Date
December 30 2029
Last Update
November 27 2023
Active Locations (1)
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1
Samsung Medical Center
Seoul, South Korea, 06351