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 @ 9:14 PM
Ignite Modification Date:
2025-12-24 @ 9:14 PM
NCT ID:
NCT03017404
Eligibility Criteria:
Inclusion Criteria:
* Female patients newly diagnosed breast cancer≥18 and ≤70 years of age;
* Karnofsky performance status≥70 and measurable or evaluable;
* Stages Ⅲa-ⅢC;
* Baseline left ventricular ejection fraction (LVEF) ≥ 50%;
* Adequate marrow function (WBC count\> 4.0×10(9)/L, neutrophil\> 2.0×10(9)/L, platelet count \> 100×10(9)/L，hemoglobin \> 90g/L );
* AST and ALT ≤1.5× institutional upper limit of normal, alkaline phosphatase
* ≤2.5×institutional upper limit of normal，bilirubin ≤institutional upper limit of normal;
* Serum creatinine ≥ 44µmol/L and ≤ 133 µmol/L;
* Expected lifetime ≥ 12 months;
* Pregnancy tests of reproductive age women is negative;
* All patients provided written informed consent.
Exclusion Criteria:
* Distant metastasis;
* Severe heart failure (NYHA grade II or higher);
* Active and uncontrolled severe infection;
* Hypersensitivity to anthracycline therapy or a history of severe hypersensitivity reactions to products containing liposomal doxorubicin and docetaxel;
* Have accepted any other anti-tumor drug within 30 days before the first dose of doxorubicin hydrochloride liposome or doxorubicin;
* Pregnancy or breast feeding;
* Other situations that investigators consider as contra-indication for this study
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03017404
Study Brief:
Protocol Section:
NCT03017404