Actively Recruiting
Regional Radiotherapy Omission in Low-Risk Node Positive Breast Cancer
Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2025-09-18
635
Participants Needed
1
Research Sites
521 weeks
Total Duration
On this page
Sponsors
S
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Lead Sponsor
S
Sun Yat-sen University
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to determine whether certain patients can safely omit regional lymph node radiotherapy. These women must have hormone-sensitive, Her2-negative tumors, have 1-3 positive axillary nodes and have RecurIndex low-risk.
CONDITIONS
Official Title
Regional Radiotherapy Omission in Low-Risk Node Positive Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 70 years old
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Postoperative diagnosis of invasive breast cancer
- Low clinical risk defined as axillary lymph node micrometastasis or N1 patients meeting all: age 40 or older, negative or limited lymphovascular invasion, estrogen receptor positive (≥1%), and HER2 negative
- Postoperative axillary lymph node status includes micrometastasis or 1-3 lymph node metastases confirmed by biopsy or dissection
- Sufficient tumor tissue available for RecurIndex testing
- Low-risk result by RecurIndex testing from breast tumor tissue
- Breast-conserving surgery or total breast resection with or without reconstruction performed
- No distant metastasis confirmed by systemic exams within 3 months before radiotherapy randomization
- Mammography and/or MRI confirming no contralateral breast cancer within 12 months before radiotherapy randomization
- Completion of at least 4 courses of adjuvant chemotherapy with anthracycline or taxane after surgery
- Radiotherapy given sequentially after chemotherapy, starting no later than 8 weeks after chemotherapy
- No previous history of malignant tumors except basal cell carcinoma of the skin
- Signed informed consent form
You will not qualify if you...
- Postoperative staging confirmed as T3-4, N0, N2-3, or M1 lesions
- Received new adjuvant therapy before surgery including chemotherapy, endocrine, targeted, or radiation therapy
- Underwent total mastectomy with only sentinel lymph node biopsy
- History of contralateral breast cancer
- History of chest radiotherapy
- Severe heart, lung, liver, kidney, blood, neurological diseases, or mental illness
- History of autoimmune diseases such as scleroderma or active lupus erythematosus
- Pregnant or breastfeeding patients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China, 510120
Actively Recruiting
Research Team
Y
Yuting Tan
CONTACT
X
Xiaobo Huang
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here