Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2025-12-24 @ 4:34 PM
NCT ID:
NCT04926766
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent
* Aged ≥18 years old
* breast conservation surgery
* unilateral histologically confirmed invasive breast carcinoma or Ductal Carcinoma In Situ (DCIS)
* For patients with invasive breast cancer，negative axillary lymph nodes or micrometastasis only
* Karnofsky Performance Status ≥80, and Life expectancy of \>5 years
* Histologically negative surgical margin for invasive breast carcinoma or a minimum negative margin width of ≥ 3mm for DCIS
* Surgery wound healed without infection
* ER (estrogen-receptor), PR (progesterone-receptor), HER2 (human epidermal growth factor receptor 2) and Ki67 testing can be performed on the primary breast tumor
* Female patients of child-producing potential must agree to use effective contraception for up to 1 month before study treatment and the duration of study participation
Exclusion Criteria:
* Histological involvement of supraclavicular lymph node
* Histologically or radiologically confirmed involvement of ipsilateral internal mammary lymph nodes
* Pregnant or lactating women
* Severe non-neoplastic medical comorbidities
* Diagnosis of non-breast malignancy within 5 years preceding enrollment (excluding lobular carcinoma in situ, basal cell carcinoma of the skin, carcinoma in situ of skin and carcinoma in situ of the cervix, Pulmonary adenocarcinoma in situ，which are permitted).
* simultaneous contralateral breast cancer
* Previous radiotherapy to the neck, chest and/or ipsilateral axillary region
* Active collagen vascular disease
* Definitive histological or radiologic evidence of distant metastatic disease
* Evidence of T4 disease
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT04926766
Study Brief:
Protocol Section:
NCT04926766