Internal Mammary Lymph Nodes Irradiation in High-risk Breast Cancer After Neoadjuvant Chemotherapy
1 other identifier
interventional
722
1 country
1
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 neoadjuvant chemotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 breast-cancer
Started Jul 2024
Typical duration for phase_3 breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 15, 2024
CompletedFirst Submitted
Initial submission to the registry
August 13, 2024
CompletedFirst Posted
Study publicly available on registry
August 19, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 15, 2032
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 15, 2032
September 19, 2024
July 1, 2024
8 years
August 13, 2024
September 10, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Disease free survival
From date of enrollment until to the first recurrence in the ipsilateral breast or chestwall, the regional nodal area, or a distant site or death due to any cause
5 years
Secondary Outcomes (3)
Overall survival
5 years
Distant metastasis-free survival
5 years
Local-regional recurrence-free survival
5 years
Study Arms (2)
internal mammary nodal irradiation
EXPERIMENTALchest wall/whole breast and supraclavicular+-axillary nodal plus internal mammary nodal irradiation
No internal mammary node irradiation
ACTIVE COMPARATORchest wall/whole breast and supraclavicular+-axillary nodal irradiation
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).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yong Yang, M.S
Fujian Medical University Union Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D.
Study Record Dates
First Submitted
August 13, 2024
First Posted
August 19, 2024
Study Start
July 15, 2024
Primary Completion (Estimated)
July 15, 2032
Study Completion (Estimated)
July 15, 2032
Last Updated
September 19, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share