Regional Lymph Node Irradiation for High-risk pN0 Breast Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Prospective Randomized Controlled Study on Precision Irradiation of Regional Lymph Node for Clinical High-risk pN0 Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Radiation: Regional lymph node radiotherapy
* Radiation: chest/whole breast irradiation


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RNI group<br> | Radiation: Regional lymph node radiotherapy<br>* Regional lymph node radiotherapy<br>Radiation: chest/whole breast irradiation<br>* chest/whole breast irradiation<br>|
| Placebo Comparator: non-RNI group<br> | Radiation: chest/whole breast irradiation<br>* chest/whole breast irradiation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 5 year disease free survival rate | Disease free survival rate from randomization to 5 years after radiotherapy | 5 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 5 year local reginal recurrence rate | The proportion of local or regional recurrence from randomization to 5 years after radiotherapy | 5 year | 
| 5 year distant metastases rate | The proportion of distant metastases occurring 5 years after radiotherapy | 5 year | 
| 5 year overall survival rate | The proportion of death occurring 5 years after radiotherapy | 5 year |