Status:
RECRUITING
Evaluating Omitting of Internal Mammary Irradiation Among Early Stage Intermediate Risk (N1) Breast Cancer
Lead Sponsor:
Ruijin Hospital
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-80 years
Phase:
NA
Brief Summary
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 interm...
Detailed Description
This study is a phase II open label, non-inferior randomized controlled trial, we aimed to compare the safety and effectiveness difference of whole breast/chest wall irradiation + IMI+SVC irradiation ...
Eligibility Criteria
Inclusion
- • Histologically confirmed invasive breast cancer
- Underwent radical surgery with either mastectomy or breast conserving surgery and axillary lymph node dissection (ALND)
- The number of positive lymph node should be 1-3 (N1).
- Clinical high risk breast cancer (≥2 clinical risk factors)
- Aged 18-80 years old
- ECOG performance status ≤2 (Karnofsky ≥70%) Anticipative overall survival \>5 years Pathologically surgical margin \>2mm ER (estrogen-receptor), PR (progesterone-receptor), HER2 (human epidermal growth factor receptor 2) and Ki67 testing can be performed on the primary breast tumor Women of child-bearing potential must agree to use adequate contraception for up to 1 month before study treatment and the duration of study participation Ability to understand and willingness to participate the research and sign the consent form
Exclusion
- • Axillary dissection of less than 10 lymph nodes
- Pathologically positive ipsilateral supraclavicular lymph node
- Pathologically or radiologically confirmed involvement of ipsilateral internal mammary lymph nodes
- Pregnant or lactating women
- Treated with breast reconstruction surgery
- Severe non-neoplastic medical comorbidities
- History of non-breast malignancy within 5 years with the exception of lobular carcinoma in situ, basal cell carcinoma of the skin, carcinoma in situ of skin and carcinoma in situ of the cervix
- simultaneous contralateral breast cancer
- Previous radiotherapy to the neck, chest and/or ipsilateral axillary region
- Active collagen vascular disease
- Definitive pathological or radiologic evidence of distant metastatic disease
- Primary T4 tumor
- Interval between radical surgery (mastectomy or breast conserving surgery) and radiotherapy was more than 12 weeks or interval between last dose of adjuvant chemotherapy and radiotherapy was more than 8 weeks
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2030
Estimated Enrollment :
214 Patients enrolled
Trial Details
Trial ID
NCT04517266
Start Date
March 1 2021
End Date
October 30 2030
Last Update
December 4 2023
Active Locations (1)
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1
Ruijin Hospital, Shanghai jiaotong univestigy school of medicine
Shanghai, Shanghai Municipality, China, 200025