prospective cohort study to evaluate the effect of regional nodal irradiation omission on the regional recurrence rate after neoadjuvant chemotherapy followed by breast conserving surgery and sentinal lymph node biopsy in clinical T1-3 with lymph node metastasis in axillary level I and ypN0 breast cancer patient

ational Cancer Center0 个研究点目标入组 844 人开始时间: 待定最近更新: 2024年4月2日

适应症

试验速览

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•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
•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

•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

发起方

ational Cancer Center