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 @ 2:39 PM
Ignite Modification Date:
2025-12-24 @ 2:39 PM
NCT ID:
NCT06754059
Eligibility Criteria:
Inclusion Criteria:
1. Age: 18-70 years old, female;
2. Pathological examination confirmed HER-2 positive invasive breast cancer; Her2-positive is defined as \>10% of tumor cells with an immunohistochemical (IHC) score of 3+ or in situ hybridization (ISH) results as HER2 gene amplification. A positive HER2 should be confirmed by the pathology department of the participating center of this study.) Imaging examination confirmed recurrent/metastatic breast cancer;
3. Patients with recurrence or metastasis more than 1 year after trastuzumab treatment, or newly diagnosed stage IV breast cancer;
4. ECOG score is 0-1;
5. Expected survival ≥6 months;
6. Normal function of major organs;
7. 1\) Blood routine • ANC≥1.5×109/L; • PLT≥90×109/L; • Hb≥90 g/L; 2) Blood biochemistry • TBIL≤1.5×ULN; • ALT and AST≤2 x ULN; For patients with liver metastases, ALT and AST≤5× ULN; • BUN and Cr ≤ 1.5×ULN and creatinine removal rate ≥ 50 mL/min; 3) Heart color ultrasound • LVEF≥50%;
8. The researcher believes that the subject is likely to benefit;
9. Voluntarily participate in the study and sign the informed consent
Exclusion Criteria:
1. Head MRI or head CT confirms the presence of brain metastases;
2. Have multiple factors affecting oral medication (history of gastrointestinal surgery, inability to swallow, chronic diarrhea, intestinal obstruction);
3. Study patients allergic to drugs and excipients;
4. Suffering from mental illness or psychotropic substance abuse, unable to cooperate;
5. Pregnant or lactating women;
6. Participated in clinical trials within 4 weeks;
7. Participants considered unsuitable for inclusion by the researchers.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT06754059
Study Brief:
Protocol Section:
NCT06754059