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 @ 4:08 PM
Ignite Modification Date:
2025-12-24 @ 4:08 PM
NCT ID:
NCT06615466
Eligibility Criteria:
Inclusion Criteria:
1. ≥45 years old, \<75 years old women
2. Life expectancy \>5 years
3. Start radiotherapy within 12 weeks after breast-conserving surgery (or within 8 weeks from the end of chemotherapy)
4. Invasive ductal carcinoma grade 1-2, or mucinous carcinoma, papillary carcinoma, canalicular carcinoma, medullary carcinoma; primary tumor
≤3.0cm; both pN0 (axillary dissection or sentinel lymph node biopsy)
5. Low-risk DCIS: tumor ≤2.5cm, low to medium grade; axillary surgery is not required or pN0
6. Single focus (with MRI diagnosis)
7. Vascular tumor thrombus negative
8. ER and/or PR positivity (defined as strong positivity in \>1% of tumor cell nuclei)
9. Negative pathological margin≥2mm
10. Place metal markers on the tumor bed
11. Sign the informed consent form
Exclusion Criteria:
1. Multiple primary tumors
2. Invasive ductal carcinoma grade 3
3. Invasive micropapillary carcinoma
4. Lobular carcinoma in situ
5. Invasive lobular carcinoma
6. Simple nipple paget's disease
7. Oncoplastic surgery
8. Neoadjuvant chemotherapy or neoadjuvant endocrine therapy
9. Previous or simultaneous contralateral breast cancer
10. History of ipsilateral chest wall radiotherapy
11. Have active collagen vascular disease
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
45 Years
Maximum Age:
74 Years
Study:
NCT06615466
Study Brief:
Protocol Section:
NCT06615466