Internal Mammary Lymph Nodes Irradiation in High-risk Breast Cancer After Neoadjuvant Chemotherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: internal mammary nodal irradiation, No internal mammary node irradiation.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: 18 years — 75 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Internal Mammary Lymph Nodes Irradiation in High-risk Breast Cancer After Neoadjuvant Chemotherapy: a Phase III Randomized, Controlled Clinical Trial
Overview
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.
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. Patients underwent regional nodal irradiation along with breast or chest wall irradiation and randomly allocated to either IMNI or no IMNI.
Interventions
- Radiation internal mammary nodal irradiation
chest wall/whole breast and supraclavicular +-axillary plus internal mammary nodal irradiation (50 Gy in 25 fractions or 40Gy in 15 fractions). - Radiation No internal mammary node irradiation
chest wall/whole breast and supraclavicular +-axillary irradiation (50 Gy in 25 fractions or 40Gy in 15 fractions).
Primary outcome measures
- Disease free survival [Time frame: 5 years]
Secondary outcome measures (3)
- Overall survival [Time frame: 5 years]
- Distant metastasis-free survival [Time frame: 5 years]
- Local-regional recurrence-free survival [Time frame: 5 years]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Fujian Medical University Union Hospital — Fuzhou
Identifiers
NCT: NCT06559696 · FMUUH-BC-2401