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 @ 2:46 AM
Ignite Modification Date:
2025-12-25 @ 2:46 AM
NCT ID:
NCT04429633
Eligibility Criteria:
Inclusion Criteria:
* Female aged ≥ 18 years
* Pathologically confirmed HER2-positive breast cancer
* Adjuvant treatment plan comprises at least 12 cycles of Trastuzumab
* Baseline echocardiogram should be performed before starting trastuzumab
* Cumulative anthracycline dose ≤ 300mg/m2
* Written informed consent to participate in the study
Exclusion Criteria:
* History of hypersensitivity or alllergic reaction to the study medication
* Metastatic breast cancer
* Treatment with angiotensin converting enzyme(ACE) inhibitor , Angiotensin receptor blocker (ARB), beta-blocking agents, or diuretics
* Patients with NCI/CTCAE grade ≥ 2 congestive heart failure, myocardial infarction, symptomatic left ventricular systolic dysfunction, heart's valve disease (≥ moderate), arrhythmias (Grade ≥ 3) \< 12 months before enrollment
* Pregnancy or breast feeding
* Baseline systolic pressure \< 90mmHg
* Cumulative anthracycline dose \> 300mg/m2
* Serious concurrent illness
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT04429633
Study Brief:
Protocol Section:
NCT04429633