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 @ 10:42 PM
Ignite Modification Date:
2025-12-24 @ 10:42 PM
NCT ID:
NCT06718335
Eligibility Criteria:
Inclusion Criteria:
1. Women aged ≥18 years and ≤75 years with newly treated breast cancer;
2. Pathological examination confirmed HER2 positive (immunohistochemistry staining +++ or immunohistochemistry staining ++ and Fluorescence in situ hybridization positive);
3. Patients with invasive breast cancer diagnosed histologically plus imaging as early (T1c-3, N0-1, M0) or locally advanced (T2-3, N2, or N3, M0);
4. Eastern Cooperative Oncology Group score 0\~1;
5. Plan to undergo the final surgical removal of breast cancer, i.e. breast conserving surgery or total mastectomy, sentinel lymph node (SN) biopsy or axillary lymph node dissection (ALND);
6. If the major organs function normally, the following criteria are met:
(1) The standard of blood routine examination should meet: absolute neutrophil count(ANC) ≥1.5×109/L; blood platelet (PLT) ≥90×109/L; Hb ≥90g/L; (2) Biochemical examination should meet the following criteria: total bilirubin(TBIL)≤ upper limit of normal value (ULN); alanine aminotransferase(ALT) and AST≤1.5 times the upper limit of normal (ULN); Alkaline phosphatase ≤2.5 times the upper limit of normal (ULN); blood urea nitrogen(BUN)and Cr≤1.5×ULN and creatinine clearance ≥50 mL/min (CockcroftGault formula); (3) Color Doppler ultrasonography and echocardiography: left ventricular ejection fraction (LVEF≥55%); (4) Fridericia calibrated QT interval (QTcF) for 18-lead ECG \<470 ms; 7. For female patients who are not menopausal or have not been surgically sterilized: consent to abstinence or use of an effective contraceptive method during treatment and for at least 7 months after the last dose in the study treatment; 8. Volunteer to join the study and sign the informed consent.
Exclusion Criteria:
1. Known allergic history of the drug components of this protocol;
2. Previously received antitumor therapy or radiation therapy for any malignant tumor (except for cured cervical carcinoma in situ and basal cell carcinoma);
3. Has undergone major non-breast cancer related surgery within 4 weeks, or has not fully recovered from such surgery;
4. Stage IV (metastatic) breast cancer patients;
5. Inability to swallow, intestinal obstruction, or other factors affecting the administration and absorption of the drug;
6. Serious heart disease or discomfort that cannot be treated;
7. Suffering from mental illness or psychotropic substance abuse, unable to cooperate;
8. Pregnant or lactating women;
9. Patients with severe liver and kidney function diseases and blood system diseases;
10. Those who were not considered suitable for inclusion by the researchers included: history of drug abuse, history of use of blood products, anticoagulant drugs and immunological drugs within the past year; Patients with poor compliance and refusal to cooperate with treatment; Patients with severe high blood pressure, diabetes and other doctors deemed unsuitable for joining the study.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06718335
Study Brief:
Protocol Section:
NCT06718335