Internal Mammary Lymph Nodes Irradiation in High-risk Breast Cancer After Neoadjuvant Chemotherapy
Internal Mammary Lymph Nodes Irradiation in High-risk Breast Cancer After Neoadjuvant Chemotherapy: a Phase III Randomized, Controlled Clinical Trial
Fujian Medical University Union Hospital
722 participants
Jul 15, 2024
INTERVENTIONAL
Conditions
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 neoadjuvant chemotherapy.
Eligibility
Inclusion Criteria8
- 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 Criteria5
- 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
Interventions
chest wall/whole breast and supraclavicular +-axillary plus internal mammary nodal irradiation (50 Gy in 25 fractions or 40Gy in 15 fractions).
chest wall/whole breast and supraclavicular +-axillary irradiation (50 Gy in 25 fractions or 40Gy in 15 fractions).
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06559696