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Recruiting Not applicable

Evaluating Omitting of Internal Mammary Irradiation Among Early Stage Intermediate Risk (N1) Breast Cancer

NCT04517266 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2021-03-01
Last updated
2026-08-11

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

omit of IMI groupIMI group

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.

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.

Study 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 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • 2-year event-free survival — 2 years
    any recurrence,distant metastasis or death in 2 years

Trial sites (1)

FacilityCityRegionStatus
Ruijin Hospital, Shanghai jiaotong univestigy school of medicine Shanghai Shanghai Municipality Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04517266 on ClinicalTrials.gov ↗ ← All trials in China