NCT04517266 Evaluating Omitting of Internal Mammary Irradiation Among Early Stage Intermediate Risk (N1) Breast Cancer
| NCT ID | NCT04517266 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ruijin Hospital |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 214 participants |
| Start Date | 2021-03-01 |
| Primary Completion | 2027-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 214 participants in total. It began in 2021-03-01 with a primary completion date of 2027-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 Criteria
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
Contact & Investigator
Wei-Xiang Qi, Dr.
PRINCIPAL INVESTIGATOR
Ruijin Hospital
Frequently Asked Questions
Who can join the NCT04517266 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 80 Years, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04517266 currently recruiting?
Yes, NCT04517266 is actively recruiting participants. Contact the research team at qiweixiang1113@163.com for enrollment information.
Where is the NCT04517266 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT04517266 clinical trial?
NCT04517266 is sponsored by Ruijin Hospital. The principal investigator is Wei-Xiang Qi, Dr. at Ruijin Hospital. The trial plans to enroll 214 participants.
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