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 @ 5:58 PM
Ignite Modification Date:
2025-12-24 @ 5:58 PM
NCT ID:
NCT04582968
Eligibility Criteria:
Inclusion Criteria:
1. Pathologically confirmed HER2 positive advanced breast cancer
2. Age\>18 years. brain metastases confirmed by enhanced brain MRI
3. KPS≥70
4. Life expectancy of more than 12 weeks
5. Prior therapy of oral dexamethasone not exceeding 16mg/d
6. Time interval from prior therapy was more than 2 weeks, and evaluation of adverse events is no more than grade 1.
7. Maximum diameter of intracranial metastases is less than 3cm measured by enhanced brain MRI(2-3mm)
8. Prior endocrine therapy were allowed
9. Anti-Her2 targeted treatment were allowed
10. 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
11. Signed the informed consent form prior to patient entry
Exclusion Criteria:
1. Leptomeningeal or hemorrhagic metastases
2. uncontrolled epilepsy
3. Severe complication: cardiovascular disease, end-stage renal disease, severe hepatic disease, infection etc.
4. Pregnancy or lactation period， women of child-bearing age who are unwilling to accept contraceptive measures.
5. Inability to complete enhanced MRI
6. Patients who are difficult or unable to be followed-up
7. Not suitable for inclusion for specific reasons judged by sponsor
8. Patients unable to swallow, with chronic diarrhea, intestinal obstruction, or multiple factors that affect drug use and absorption
9. History of allergy to pyrotinib or capetabine
10. History of immunodeficiency, including HIV positive, active HBV/HCV or other acquired, congenital immunodeficiency disease, or organ transplantation history
11. Previous use of pyrotinib combined with capetabine
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT04582968
Study Brief:
Protocol Section:
NCT04582968