Actively Recruiting
Evaluating Omitting of Internal Mammary Irradiation Among Early Stage Intermediate Risk (N1) Breast Cancer
Led by Ruijin Hospital · Updated on 2023-12-04
214
Participants Needed
1
Research Sites
504 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The effect of internal mammary irradiation (IMI) added to whole-breast or thoracic-wall irradiation plus supraclavicular (SVC) irradiation after surgery on survival among women with early-stage intermediate risk (N1) breast cancer remains debated. The present study aimed to identified patient could be omitted from internal mammary lymph node irradiation by using a clinical-genomic model.
CONDITIONS
Official Title
Evaluating Omitting of Internal Mammary Irradiation Among Early Stage Intermediate Risk (N1) Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed invasive breast cancer
- Underwent radical surgery with mastectomy or breast conserving surgery and axillary lymph node dissection
- Number of positive lymph nodes between 1 and 3 (N1)
- Clinical high risk breast cancer with at least 2 clinical risk factors
- Aged between 18 and 80 years
- ECOG performance status of 2 or less (Karnofsky score 70% or higher)
- Expected overall survival greater than 5 years
- Surgical margin greater than 2 mm
- Estrogen receptor (ER), progesterone receptor (PR), HER2, and Ki67 testing performed on the primary tumor
- Women of childbearing potential agree to use effective contraception for at least 1 month before and during the study
- Ability to understand and willingness to participate and sign consent form
You will not qualify if you...
- Axillary dissection with fewer than 10 lymph nodes removed
- Pathologically positive ipsilateral supraclavicular lymph nodes
- Confirmed involvement of ipsilateral internal mammary lymph nodes by pathology or imaging
- Pregnant or breastfeeding women
- Previous breast reconstruction surgery
- Severe serious medical conditions unrelated to cancer
- History of non-breast cancer within 5 years except certain in situ or skin cancers
- Simultaneous cancer in the opposite breast
- Previous radiotherapy to the neck, chest, or same side armpit area
- Active collagen vascular disease
- Confirmed distant metastatic disease by pathology or imaging
- Primary tumor classified as T4
- More than 12 weeks between surgery and radiotherapy or more than 8 weeks between last chemotherapy dose and radiotherapy
AI-Screening
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Trial Site Locations
Total: 1 location
1
Ruijin Hospital, Shanghai jiaotong univestigy school of medicine
Shanghai, Shanghai Municipality, China, 200025
Actively Recruiting
Research Team
W
Wei-Xiang Qi, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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