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 @ 11:47 AM
Ignite Modification Date:
2025-12-24 @ 11:47 AM
NCT ID:
NCT07135661
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥ 40 years
2. Pathologically (cytologically or histologically) confirmed unilateral primary invasive breast carcinoma
3. Breast conserving surgery + sentinel lymph node biopsy/axillary lymph node dissection, pathological stage pT1-2N0M0，negative margins (≥ 2 mm)
4. No distant metastasis confirmed by CT, MRI, bone scan, and PET/CT
5. No prior radiation therapy to the ipsilateral chest or breast
6. ECOG 0 \~ 2 or KPS ≥ 70
Exclusion Criteria:
1. Without pathology diagnosis
2. Positive margins or close margins (\< 2mm)
3. Lymph nodes or distant metastasis
4. Bilateral breast cancer or patients with a history of contralateral breast cancer
5. Prior radiation therapy to the ipsilateral chest or breast
6. Pregnancy (confirmed by serum or urine β-HCG test) or lactation
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
40 Years
Study:
NCT07135661
Study Brief:
Protocol Section:
NCT07135661