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:
2025-12-26 @ 4:03 PM
Ignite Modification Date:
2025-12-26 @ 4:03 PM
NCT ID:
NCT06964906
Eligibility Criteria:
Inclusion Criteria:
1. Female patients aged 18-75 years.
2. Invasive breast cancer without distant metastasis, including either T1c-T2 (≥ 2 cm), cN1-cN2, or T3-T4, cN0-cN2.
3. Histopathologically confirmed ER-positive/HER2-negative, PR \< 20% or Ki67 ≥ 20%, Grade 3 breast cancer.
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Exclusion Criteria:
1. Female patients during pregnancy or lactation.
2. Diagnosis of bilateral breast cancer, occult breast cancer, or distant metastasis confirmed by pathology.
3. Has an active autoimmune disease that has received systemic treatment in the last 2 years.
4. Has a known history of human immunodeficiency virus (HIV), hepatitis B, or known active hepatitis C virus infection.
5. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
6. Has a known history of invasive malignancy that required systemic treatment in the last 5 years.
7. Uncontrolled concomitant diseases include severe infection, liver disease, cardiovascular disease, kidney disease, respiratory disease, diabetes, and others requiring systemic treatment.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06964906
Study Brief:
Protocol Section:
NCT06964906