Randomized Study of Elective Regional Lymph Node Irradiation in N1 Breast Cancer
NCT ID: NCT03269981
Last Updated: 2023-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
827 participants
INTERVENTIONAL
2017-04-01
2029-12-30
Brief Summary
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Detailed Description
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* 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 to molecular subtype of tumor.
* Compare the treatment-related toxicities between the WBI and WB+RNI.
* Compare the patient's quality of life between the WBI and WB+RNI.
Outline: This is a a randomized, multi-center, phase III study. Patients are stratified according to molecular subtype of tumor (luminal A vs luminal vs luminal HER2 vs HER2-enriched vs basal-like), axillary lymph node management (sentinel lymph node biopsy \[SLN\] only vs axillary lymph node dissection+/- SLN) and participating institutions. Patients are randomized to one of two treatment arms.
* Arm I: Patients receive WB+RNI.
* Arm II: Patients receive WBI alone.
Arm circumference and quality of life (EORTC QLQ-C30 \& EORTC QLQ-BR23) are assessed within 2 weeks prior to randomization, during the last week of radiotherapy, at 3 months after completion of radiotherapy, and then annually thereafter for five years.
Patients are followed at 3 months after completion of radiotherapy and annually thereafter for seven years.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Whole breast irradiation
Post-lumpectomy radiotherapy to the whole breast alone.
Whole breast irradiation
Radiotherapy to the whole breast alone.
Whole breast and nodal irradiation
Post-lumpectomy radiotherapy to the whole breast and regional lymph node.
Whole breast and nodal irradiation
Radiotherapy to the whole breast and regional lymph nodes.
Interventions
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Whole breast irradiation
Radiotherapy to the whole breast alone.
Whole breast and nodal irradiation
Radiotherapy to the whole breast and regional lymph nodes.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
20 Years
70 Years
FEMALE
No
Sponsors
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Korean Radiation Oncology Group
UNKNOWN
Ministry of Health, Republic of Korea
OTHER_GOV
Samsung Medical Center
OTHER
Responsible Party
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Principal Investigators
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Won Park, MD
Role: STUDY_CHAIR
Samsung Medical Center
Locations
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Samsung Medical Center
Seoul, , South Korea
Countries
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Other Identifiers
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SMC 2017-01-085-001
Identifier Type: -
Identifier Source: org_study_id