Actively Recruiting
RecurIndex Guided Avoidance of Regional Nodal Irradiation for Node Positive Breast Cancer
Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2025-09-22
540
Participants Needed
1
Research Sites
593 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 validate whether clinically low-risk, and RecurIndex high-risk N1 patients receiving regional lymph node radiotherapy can further improve clinical outcomes.
CONDITIONS
Official Title
RecurIndex Guided Avoidance of Regional Nodal Irradiation for 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 pathology confirming invasive breast cancer
- Clinically low-risk defined by specific lymph node micrometastasis or N1 status with age ≥40 years, limited vascular tumor thrombus, and allowed breast cancer subtypes (Lumina A, Lumina B/HER2 negative, Lumina B/HER2 positive)
- Postoperative axillary lymph node status confirmed by sentinel lymph node biopsy and/or axillary lymph node dissection within specified micrometastasis or macrometastasis limits
- Primary tumor treated with breast-conserving surgery or total resection with or without breast reconstruction
- Adequate systemic examination within 3 months before radiotherapy randomization confirming no distant metastasis
- No contralateral breast cancer confirmed by imaging within 12 months before radiotherapy randomization
- Completion of at least 4 courses of adjuvant chemotherapy with anthracycline or taxane after surgery; chemotherapy may be omitted for certain HR positive, HER2 negative low-risk tumors after Multigene Assays
- Radiotherapy to begin no later than 8 weeks after adjuvant chemotherapy completion
- Availability of primary fresh frozen specimens or post-paraffin tissue sections for RecurIndex testing
- No previous malignant tumors except basal cell carcinoma of the skin
- Signed informed consent
You will not qualify if you...
- Postoperative radiotherapy staging of T3-4, N0, N2-3, or M1 lesions
- Receipt of any new adjuvant therapy before surgery including chemotherapy, endocrine, targeted, or radiation therapy
- Total mastectomy with only sentinel lymph node biopsy
- History of contralateral breast cancer
- Previous chest radiotherapy
- Severe heart, lung, liver, kidney, hematopoietic, neurological diseases, or mental illness
- History of autoimmune diseases such as scleroderma or active lupus erythematosus
- Pregnant or lactating 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
X
Xiaobo Huang, MD
CONTACT
T
Tan Yuting
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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