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 @ 4:13 PM
Ignite Modification Date:
2025-12-24 @ 4:13 PM
NCT ID:
NCT06631066
Eligibility Criteria:
Inclusion Criteria:
1. Female patients.
2. Age: 21 years or older.
3. ECOG performance status (PS) score 0 to 2.
4. Locally advanced tumors (stage IIIA or above) of any subtype.
5. Early breast cancer of the HER2+ or TNBC subtype when:
1. Node-negative, T2 or T3.
2. Node-positive, any T stage.
Exclusion Criteria:
1. Patients initially presenting with metastatic breast cancer.
2. Patients unfit to receive planned regimen of treatment that had a poor PS (i.e.: PS 3 and 4).
3. Inflammatory breast cancer (T4d) patients.
4. Patients having contraindications to radiotherapy (e.g.: Pregnancy, history of previous chest wall, breast, or axillary irradiation)
5. History of previous ipsilateral breast surgery.
6. Comorbidities that would affect skin healing or integrity, like uncontrolled diabetes mellitus or active autoimmune collagen or vascular diseases
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
21 Years
Maximum Age:
65 Years
Study:
NCT06631066
Study Brief:
Protocol Section:
NCT06631066