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 @ 9:09 PM
Ignite Modification Date:
2025-12-24 @ 9:09 PM
NCT ID:
NCT05642104
Eligibility Criteria:
Inclusion Criteria:
* Age 18-65, female;
* Pathological biopsy confirmed invasive ductal carcinoma;
* Karnofsky Performance Status (KPS)≥ 60, expected survival ≥4 months;
* Locally advanced breast cancer (HER2-positive disease and TNBC, ≥cT1c or ≥cN0； HER2-negative，HR positive disease，≥cT2 or ≥cN1；Large primary tumor relative to breast size in a patient who desires breast conservation) ;
* According to the RECIST1.1 standard, at least one measurable lesion exists;
Exclusion Criteria:
* Pregnant or lactating women;
* Left ventricular ejection fraction less than 50%;
* History of malignant tumor and concurrent occurrence of other tumors;
* Serious medical pathology, such as congestive heart failure; unstable angina; uncontrolled high risk arrhythmias, and other serious illness or medical condition that may interfere with the study;
* Refuse to participate in the study.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05642104
Study Brief:
Protocol Section:
NCT05642104