study to evaluate the effect of regional nodal irradiation omission in ypN0 breast cancer patient

Not Applicable

Recruiting

Conditions: Neoplasms

Registration Number: KCT0004567

Lead Sponsor: ational Cancer Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Female

Target Recruitment: 844

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

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

Study & Design

Study Type: Observational Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
regional recurrence rate

Secondary Outcome Measures

Name	Time	Method
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