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Trial Title:
Internal Mammary Lymph Nodes Irradiation in High-risk Breast Cancer After Neoadjuvant Chemotherapy
NCT ID:
NCT06559696
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Breast Cancer
Internal mammary nodal
Radiation
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
internal mammary nodal irradiation
Description:
chest wall/whole breast and supraclavicular +-axillary plus internal mammary nodal
irradiation (50 Gy in 25 fractions or 40Gy in 15 fractions).
Arm group label:
internal mammary nodal irradiation
Intervention type:
Radiation
Intervention name:
No internal mammary node irradiation
Description:
chest wall/whole breast and supraclavicular +-axillary irradiation (50 Gy in 25 fractions
or 40Gy in 15 fractions).
Arm group label:
No internal mammary node irradiation
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.
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.
Criteria for 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
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Fujian Medical University Union Hospital
Address:
City:
Fuzhou
Zip:
350001
Country:
China
Status:
Recruiting
Contact:
Last name:
Yong Yang, Doctor
Phone:
18813019084
Email:
dr_yangyong1983@163.com
Start date:
July 15, 2024
Completion date:
July 15, 2032
Lead sponsor:
Agency:
Fujian Medical University Union Hospital
Agency class:
Other
Source:
Fujian Medical University Union Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06559696
