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 @ 4:04 PM
Ignite Modification Date:
2025-12-24 @ 4:04 PM
NCT ID:
NCT05838066
Eligibility Criteria:
Key Inclusion Criteria:
* Voluntarily enrolled in this study and signed an informed consent form (ICF).
* Age ≥ 18 years.
* Recurrent or metastatic breast cancer confirmed by histology and/or cytology.
* Latest tumor tissue sample confirmed as HER2 positive by central laboratory testing.
* No prior systemic chemotherapy and/or HER2-targeted therapy for recurrent or metastatic breast cancer.
* Eastern Cooperative Oncology Group (ECOG) physical status score of 0 - 1.
* Presence of lesion (RECIST 1.1).
* Adequate organ and bone marrow function
Key Exclusion Criteria:
* Ineligible for any of the agents on the study
* Untreated or unstable parenchymal metastases, spinal cord metastases or compression, or carcinomatous encephalitis.
* Pregnant or lactating women.
* Presence of other circumstances that may interfere with the subject's participation in the study procedures or are inconsistent with the maximum benefit of the subject's participation in the study or affect the results of the study: e.g., history of mental illness, drug or substance abuse, any other disease or condition of clinical significance, etc.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05838066
Study Brief:
Protocol Section:
NCT05838066