Overview
This study is a non blind, randomized controlled study, whose hypothesis was that chest wall/whole breast combined regional lymph node radiotherapy can improve the 5-year disease-free survival rate of clinical high-risk pN0 breast cancer patients.
Eligibility
Inclusion Criteria:
Voluntarily participate and sign an informed consent form; Age>18 years old, female;
received radical surgery for breast cancer, including breast conservation surgery or
mastectomy, combined with Sentinel lymph node biopsy or axillary lymph node dissection;
Invasive cancer, postoperative axillary lymph node negative, with pathological staging of
T1-3N0M0 stage (Stage IA, IIA, IIB); including two or more high-risk factors based on four
clinical high-risk recurrence factors [tumor size (>2cm), tumor site (medial and central
quadrants), Ki-67 level (>14%), and vascular status (positive)]; KPS ≥ 80, estimated
survival time >5 years; Complete healing of Surgical incision, no incision infection, etc;
Reproductive period women should undergo contraception for at least one month before study,
and promise to use contraception throughout the entire study period and continue until the
specified time after the end of the study
Exclusion Criteria:
Pregnant or lactating women; Received neoadjuvant therapy; with serious non neoplastic
medical complications that affect the implementation of radiotherapy; History of malignant
tumor in the past 5 years (excluding previous lobular Carcinoma in situ, skin Basal-cell
carcinoma, skin Carcinoma in situ, cervical Carcinoma in situ and lung Carcinoma in situ);
Simultaneous contralateral breast cancer; Previous history of neck, chest, or ipsilateral
axillary radiotherapy; Active collagen vascular disease; distant metastasis confirmed by
pathology or imaging;