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:
2025-12-25 @ 1:04 AM
Ignite Modification Date:
2025-12-25 @ 1:04 AM
NCT ID:
NCT04290793
Eligibility Criteria:
Inclusion Criteria:
1. Female breast cancer patients at the age of \>= 18 years and \<= 65 years who received first treatment；
2. Pathologically confirmed HER2-positive invasive breast cancer（which is defined as the immunohistochemistry score of \> 10% immunoreactive cells being 3+ or in situ hybridization results showing HER2 gene amplification），regardless of hormone receptor status (ER and PR)；
3. According to the 2019 CSCO BC guidelines: When HER-2 positive is used as the standard for preoperative neoadjuvant therapy for breast cancer, the tumor is larger than 2 cm；
4. The Eastern Tumor Collaborative Group (ECOG) has a physical status score of ≤1；
5. The functional level of the main organs must meet the following requirements ： 1) blood routine test: hemoglobin (Hb) ≥ 90g/L;Neutrophils (ANC) ≥ 1.5 × 10\^9/L; platelet count (PLT) ≥ 90 × 10\^9/L; 2) Blood biochemistry: Total bilirubin (TBIL) ≤ 1.5 upper limit of normal value (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 × ULN; alkaline phosphatase ≤ 2.5 × ULN; Urea nitrogen (BUN) and creatinine (Cr) ≤ 1.5 × ULN; 3) Heart color ultrasound: Left ventricular ejection fraction (LVEF) ≥ 55%;
6. Women of childbearing age, tested negative for serum pregnancy test 7 days before randomization，and willing to use appropriate methods during the trial and within 8 weeks after the last administration of the test drug;
7. A volunteer to participate in the study; provision of written informed consent; good compliance and willing to cooperate during the follow-up.
Exclusion Criteria:
1. Known history of hypersensitivity to pyrotinib or any of it components;
2. Patients have previously received antitumor treatment or radiation therapy for any malignant tumor (except for cervical carcinoma in situ and basal cell carcinoma that have been cured);
3. Patients underwent major breast cancer-free surgery within 4 weeks and have not fully recovered;
4. Subjects that are unable to swallow tablets,intestinal obstruction or dysfunction of gastrointestinal absorption;
5. Patients with severe heart disease or discomfort who cannot be treated;
6. The patient suffers from mental illness or psychotropic substance abuse and cannot cooperate;
7. Pregnant or lactating women;
8. Less than 4 weeks from the last clinical trial;
9. Patients participating in other clinical trials at the same time
10. The researchers think inappropriate.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04290793
Study Brief:
Protocol Section:
NCT04290793