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 @ 4:20 PM
Ignite Modification Date:
2025-12-24 @ 4:20 PM
NCT ID:
NCT03735966
Eligibility Criteria:
Inclusion Criteria:
1. female patients, 18 years ≤ age ≤ 75 years.
2. Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1.
3. Histologically confirmed invasive breast cancer（early stage or locally advanced）:Primary tumour greater than 2 cm diameter
4. HER2 positive (HER2+++ by IHC or FISH+)
5. Life expectancy of more than 3 months
6. Known hormone receptor status.
7. Required laboratory values including following parameters: ANC: ≥ 1.5 x 10\^9/L;Platelet count: ≥ 100 x 10\^9/L;Hemoglobin: ≥ 9.0 g/dL;Total bilirubin: ≤ 1.5 x upper limit of normal (ULN);ALT and AST: ≤ 1.5 x ULN (or ≤ 5×ULN in patients with liver metastases);BUN and creatine clearance rate: ≥ 50 mL/min;LVEF: ≥ 50%;QTcF: \< 470 ms for female and \< 450 ms for male.
8. Signed the informed consent form prior to patient entry.
Exclusion Criteria:
1. metastatic disease (Stage IV) or inflammatory breast cancer.
2. Previous or current history of malignant neoplasms, except for curatively treated:Basal and squamous cell carcinoma of the skin,Carcinoma in situ of the cervix.
3. clinically relevant cardiovascular disease:Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ≥180/110);
4. Unable or unwilling to swallow tablets.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03735966
Study Brief:
Protocol Section:
NCT03735966