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 @ 11:24 PM
Ignite Modification Date:
2025-12-24 @ 11:24 PM
NCT ID:
NCT06088056
Eligibility Criteria:
Inclusion Criteria:
* Pathologically confirmed HER2 positive advanced breast cancer
* Age\>18 years.
* Brain metastases confirmed by enhanced brain MRI. Metastases number less than 15.
* KPS≥70 or KPS ≥60 with neurologic symptoms caused by BM
* Life expectancy of more than 6 months
* Prior therapy of oral dexamethasone not exceeding 16mg/d
* Time interval from prior therapy was more than 2 weeks, and evaluation of adverse events is no more than grade 1.
* Screening laboratory values must meet the following criteria( and should be obtained within 28 days prior to registration):
1. Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L, Platelets≥ 90 x 109/L, Hemoglobin ≥ 90 g/L
2. Aspartate aminotransferase/alanine aminotransferase (AST/ALT) ≤2.5 x ULN without liver metastasis,≤ 5 x ULN with liver metastases
3. Serum BUN and creatinine ≤ 1.5 x Upper Limit of Normal (ULN)
4. LVEF ≥ 50%
5. QTcF \< 480 ms
6. INR≤1.5×ULN，APTT≤1.5×ULN
* Signed the informed consent form prior to patient entry
Exclusion Criteria:
* Leptomeningeal or hemorrhagic metastases
* Uncontrolled epilepsy
* Severe or uncontrolled disease: severe cardiovascular disease, end-stage renal disease, severe hepatic disease, history of immunodeficiency, including HIV positive, active HBV/HCV or other acquired congenital immunodeficiency disease, or organ transplantation history, active infection, etc.
* History of allergy to treatment regimens
* Pregnancy or lactation period， women of child-bearing age who are unwilling to accept contraceptive measures.
* Inability to complete enhanced MRI
* Not suitable for inclusion for specific reasons judged by sponsor
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT06088056
Study Brief:
Protocol Section:
NCT06088056