Status:
RECRUITING
Internal Mammary Lymph Nodes Irradiation in High-risk Breast Cancer After Neoadjuvant Chemotherapy
Lead Sponsor:
Fujian Medical University Union Hospital
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-75 years
Phase:
PHASE3
Brief Summary
The aim of this study is to explore the impact of internal mammary nodal irradiation on disease-free survival in high-risk breast cancer patients (ypN+or supra/subclavicular lymph node positive) after...
Detailed Description
This is a prospective, randomized phase 3 trial. Breast cancer patients with axillary lymph node-positive or supra/subclavicular lymph node metastasis underwent neoadjuvant chemotherapy were included....
Eligibility Criteria
Inclusion
- Histologically confirmed invasive breast cancer
- Underwent neoadjuvant chemotherapy
- Eastern Cooperative Oncology Group Performance Status Scale 0-2
- ypN+ after neoadjuvant chemotherapy or supraclavicular/subclavicular lymph node metastasis before system therapy
- No distant metastases
- No internal mammary nodes metastases based on images before system therapy
- Willing to follow up
- Written,informed consent
Exclusion
- Without neoadjuvant chemotherapy
- Distant metastases
- Simultaneous bilateral breast cancer
- Pathological confirmation or imaging consideration of lymph node metastasis in the internal mammary before system therapy
- Had simultaneous or previous secondary malignancies, except for non-malignant melanoma skin cancer, papillary thyroid / follicular carcinoma, cervical carcinoma in situ, contralateral non-invasive breast cancer
Key Trial Info
Start Date :
July 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 15 2032
Estimated Enrollment :
722 Patients enrolled
Trial Details
Trial ID
NCT06559696
Start Date
July 15 2024
End Date
July 15 2032
Last Update
September 19 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350001