Breast Cancer
Conditions
Brief summary
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.
Interventions
RADIATIONRegional lymph node radiotherapy
Regional lymph node radiotherapy
RADIATIONchest/whole breast irradiation
chest/whole breast irradiation
Sponsors
Ruijin Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 5 year disease free survival rate | 5 year | Disease free survival rate from randomization to 5 years after radiotherapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 5 year local reginal recurrence rate | 5 year | The proportion of local or regional recurrence from randomization to 5 years after radiotherapy |
| 5 year distant metastases rate | 5 year | The proportion of distant metastases occurring 5 years after radiotherapy |
| 5 year overall survival rate | 5 year | The proportion of death occurring 5 years after radiotherapy |
Countries
China
Contacts
Primary ContactDan Ou, MD
Outcome results
None listed