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 @ 1:59 PM
Ignite Modification Date:
2025-12-24 @ 1:59 PM
NCT ID:
NCT07046195
Eligibility Criteria:
Inclusion Criteria:
1. Age 18-65 years;
2. Triple negative invasive breast cancer, with immunohistochemistry confirming that the primary lesion was ER- or ER\<10% and weakly expressed, PR-, HER 2-;
3. Patients who had surgery after neoadjuvant immunotherapy, and required a hypofractionated radiotherapy regimen of whole breast/chest wall ± regional lymph nodes ±tumor bed: whole breast/chest wall ± regional lymph nodes DT 40.05Gy/15F; Sequential dose increase of DT 2.9 Gy\*3F for tumor bed in breast conserving patients; For patients with a stage of T4 or N3c, it is up to the radiation oncologist to decide whether to proceed with sequential bolsing of locoregional lesions;
4. Patients received adjuvant immunotherapy after neoadjuvant immunotherapy, and the drugs used for postoperative immune maintenance were the immunodrugs used in the neoadjuvant treatment stage;
5. Patients who have not received neoadjuvant immunotherapy and require 1 year of adjuvant immunotherapy and hypofractionated intensity-modulated radiotherapy for whole breast/chest wall ± regional lymph nodes ± tumor beds in the postoperative adjuvant stage.
Exclusion Criteria:
1. Failure to complete the course of radiotherapy as planned
2. Concomitant contralateral breast cancer or second primary malignancy (except basal cell carcinoma of the skin and carcinoma in situ of the cervix);
3. Previous history of thoracic radiotherapy;
4. Serious heart, lung, liver, kidney, hematopoietic and nervous system diseases, mental diseases;
5. Concomitant autoimmune diseases such as scleroderma or active lupus erythematosus; pregnant and lactating patients;
6. Patients with prior immunotherapy-related grade 3-4 toxicities during the neoadjuvant immunotherapy phase
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07046195
Study Brief:
Protocol Section:
NCT07046195