None listed
Conditions
Interventions
Radiation : (1) Complete remission group (ypN0 and breast ypCR)
Random allocation (using a random allocation table)
(1-A) Boost up to 60Gy EQD2(3.5) (control arm) to lymph node areas not surgically re
Sponsors
National Cancer Center
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women aged 20-70 2. Patient must have pathologically diagnosed as invasive breast cancer 3. Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 4. Patient must have clinically T1-4 breast cancer (before standard neoadjuvant chemotherapy±targeted therapy) 5. Patient must have lymph node metastasis in axillary level II-III and/or internal mammary and/or supraclavicular lymph node confirmed by fine needle aspirate(FNA) or imaging study (before standard neoadjuvant chemotherapy±targeted therapy) 6. Patient who have undergone breast conserving surgery or total mastectomy 7. Patient who have undergone sentinel lymph node biopsy, axillary lymph node sampling, or axillary lymph node dissection 8. Patients with hormone receptors, HER-2, Ki-67 index test results (HER-2 2+ cases require FISH or SISH) (Ki-67 index test is optional)
Exclusion criteria
Exclusion criteria: 1. In the case of distant metastasis (before standard neoadjuvant chemotherapy±targeted therapy) 2. Bilateral breast cancer patients 3. Male breast cancer patients 4. Patient with a history of radiation therapy to the ipsilateral breast or supraclavicular area in the past 5. Patient diagnosed with another cancer within 5years from the start date of radiation therapy(except for thyroid cancer, in situ cervical cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) 6. If pregnant or breastfeeding 7. If standard neoadjuvant chemotherapy±targeted therapy has not been completed as planned 8. If there is no level II-III axillary lymph node involvement or supraclavicular lymph node metastasis, and only internal mammary lymph node metastasis is present at the time of diagnosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The cumulative incidence rate of lymphedema over 3 years | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) 5-year cumulative side effect incidence rate (lymphedema, shoulder joint stiffness, radiation pneumonitis, brachial plexopathy, myocardial infarction) (2) 5-year lymph node area recurrence rate, non local recurrence survival rate, disease-free survival rate, cancer-specific survival rate, overall survival rate (3) Quality of life (4) Stratified analysis and subgroup analysis based on molecular subtypes. (5) Analysis of differences in side effects based on radiation therapy fractionation methods (conventional fractionation vs hypofractionation) | — |
Countries
Korea, Republic of
Contacts
Public ContactMyoung JI Kim
National Cancer Center
Outcome results
None listed