Recruiting
Evaluating Omitting of Internal Mammary Irradiation Among Early Stage Intermediate Risk (N1) Breast Cancer
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.
ClinicalTrials.gov IDNCT04517266
PhaseNA
Enrollment214
SponsorRuijin Hospital
Age18 Years – 80 Years
SexFEMALE
About this study
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.
Interventions
- Radiation: omit of IMI group — clincial high risk breast (≥2 risk factors)patients with 18-gene low risk an indication for regional nodal irradiation will received 2 Gy for 25 fractions to chest wall or whole breast and supraclavicular lymph nodes irradiation and sequential tumor bed boost of 2 Gy for 5 fractions following breast conserving surgery.
- Radiation: IMI group — clincial high risk breast (≥2 risk factors)patients with 18-gene low risk an indication for regional nodal irradiation will received 2 Gy for 25 fractions to chest wall or whole breast and supraclavicular lymph nodes irradiation and sequential tumor bed boost of 2 Gy for 5 fractions following breast conserving surgery.
Primary outcomes
- 2-year event-free survival (2 years)
Eligibility information
Inclusion Criteria:
* • 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 Criteria:
* • 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
Study locations
- Ruijin Hospital, Shanghai jiaotong univestigy school of medicine, Shanghai, Shanghai Municipality 200025 China
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-11-13.