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:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2025-12-25 @ 12:06 AM
NCT ID:
NCT07254858
Eligibility Criteria:
Inclusion Criteria:
1. Newly diagnosed, untreated breast cancer;
2. Age: 18 years ≤ age ≤ 75 years;
3. Histologically confirmed hormone receptor-positive (HR+) tumor specimen (estrogen receptor \[ER\] ≥ 10%);
4. Human epidermal growth factor receptor-2 immunohistochemistry (HER2-IHC) result of 0/1+ or 2+ with negative fluorescence in situ hybridization (FISH) test;
5. Histologically confirmed cell proliferation index (Ki67) ≥ 20%;
6. Programmed death-ligand 1 combined positive score (PD-L1 CPS) evaluable (i.e., availability of fresh/archived specimens);
7. Good pulmonary function;
8. Adequate hepatic and renal function;
9. Histological grade ≥ 2;
10. cN0, cT ≥ 3 cm or cN1-3, cT ≥ 2 cm (cT: clinically assessed maximum diameter of primary tumor; cN: clinically assessed regional lymph node status);
11. Eastern Cooperative Oncology Group Performance Status (ECOG score) 0-1. Exclusion Criteria:
1.Pregnancy; 2.Tumor \> 8 cm with skin ulceration; 3.History of thoracic radiotherapy or contraindications to radiotherapy; 4.Active autoimmune disease; 5.Prior use of PD-L1 antibody therapy; 6.De novo breast cancer; 7.There are factors that may significantly increase the risk of lung or cardiac toxicity related to radiotherapy, such as (1) maximum lung depth(MLD) \>3.2cm； (2) maximum heart distance(MHD) \<2.4cm。
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07254858
Study Brief:
Protocol Section:
NCT07254858