None listed
Conditions
Interventions
None listed
Sponsors
National Cancer Center
Samsung Medical Center
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Ages eligible for study: between 20-70 years old 2. Patient must have had pathologic confirmation of invasive breast cancer 3. The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 4. Patient must have clinically T1-3 (before neo-adjuvant therapy) 5. Patient must have axillary level I nodal involvement at presentation (before neo-adjuvant therapy) based on either a positive fine needle aspirate (FNA) or positive in positron emission tomography (PET) scan 6. Patients with metastatic lymph node at axilla level I only 7. Patient who have undergone breast conserving surgery 8. Patient who have undergone either sentinel lymph node biopsy or axillary lymph node sampling 9. Patients with pathologic staging of ypN0, ypN0(i+) or ypN0(mol+) are eligible (Note: postneo-adjuvant therapy is designated with a "yp" prefix.) 10. Patients must have had estrogen receptor (ER), progesterone receptor (PR), HER2, and Ki-67 index testing performed on the primary breast tumor before neo-adjuvant therapy
Exclusion criteria
Exclusion criteria: 1. T4 tumors including inflammatory breast cancer 2. Definitive clinical or radiologic evidence of metastatic disease 3. Patients with metastatic lymph node at axilla level II-III, internal mammary and supraclavicular area by imaging 4. Patient must have not completed a minimum of 50% of standard neo-adjuvant chemotherapy 5. Patients who showed progression during neo-adjuvant chemotherapy 6. Patient who have undergone mastectomy 7. Patient who have undergone axillary lymph node dissection 8. Bilateral breast cancer patients 9. Male breast cancer patients 10. Prior breast or thoracic radiation therapy (RT) for any condition 11. History of non-breast malignancies (except for in situ cervical cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior to radiotherapy 12. Pregnancy or lactation at the time of study entry
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| regional recurrence rate | — |
Secondary
| Measure | Time frame |
|---|---|
| cumulative toxicity rate (lymphedema, brachial plexopathy, shoulder joint range of motion decreased, radiation pneumonitis, myocardial infartion);local recur-free survival, diease-free survival, cancer-specific survival, overall survival;Quality of life;molecular subtype layering analysis and subgroup analysis | — |
Countries
Korea, Republic of
Contacts
Public ContactMyoung JI Kim
National Cancer Center
Outcome results
None listed