Regional Lymph Node Irradiation for High-risk pN0 Breast Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: RNI group
|
Radiation: Regional lymph node radiotherapy
Regional lymph node radiotherapy
Radiation: chest/whole breast irradiation
chest/whole breast irradiation
|
| Placebo Comparator: non-RNI group
|
Radiation: chest/whole breast irradiation
chest/whole breast irradiation
|
Outcome Measures
Primary Outcome Measures
- 5 year disease free survival rate [5 year]
Disease free survival rate from randomization to 5 years after radiotherapy
Secondary Outcome Measures
- 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
Eligibility Criteria
Criteria
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;
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ruijin Hospital, Shanghai jiaotong univestigy school of medicine | Shanghai | Shanghai | China | 200025 |
Sponsors and Collaborators
- Ruijin Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2023（148）