A double blind, placebo controlled study to assess the safety and efficacy of PCD-04 as a protective agent against anthracycline-induced cardiotoxicity.
Completed
- Conditions
- Breast cancer patients.
- Registration Number
- NL-OMON21418
- Lead Sponsor
- TT Bio-Pharma Co.Ltd.Atago Green Hills MORI Tower 26F2-5-1, AtagoMinato-ku, Tokyo 105-6201 Japan
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 72
Inclusion Criteria
1. Female;
Exclusion Criteria
1. Patients with indication of distant metastases of breast carcinoma;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assessment of safety: <br /> <br>this include evaluation of general safety (Blood pressure, heartrate, monitoring of the patient during infusion, laboratory tests, urinalysis).<br /><br><br /><br /><br>Pharmacokinetics:<br /> <br>PSD-04 plasma concentrations during study days.<br /><br><br /><br /><br>Pharmacodynamics (primary):<br /><br>Echocardiography: Left ventricular diastolic function parameters and ejection fraction.
- Secondary Outcome Measures
Name Time Method Pharmacodynamics (secondary):<br /><br>1. Biochemical markers for myocardial damage;<br><br />2. ECG parameters.<br>