A double blind, placebo controlled study to assess the safety and efficacy of PCD-04 as a protective agent against anthracycline-induced cardiotoxicity.
- Conditions
- Breast cancerCancer
- Registration Number
- ISRCTN56637853
- Lead Sponsor
- TT Bio-Pharma (Japan)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 72
1. Female
2. Willing and able to give written informed consent
3. Between 20 - 75 years of age
4. Scheduled for the current clinical routine protocol for adjuvant chemotherapy for carcinoma of the breast consisting of doxorubicin/cyclophosphamide cycles
1. Patients with indication of distant metastases of breast carcinoma
2. Inability to obtain a good quality echocardiogram before study drug administration
3. Patients who are unable to remain in supine condition for more than one hour
4. Patients with (a history of) malignant disease other than carcinoma of the breast
5. Patients with hepatic disorders evidenced by elevated transamines above three times the upper limit of normal
6. Patients with a renal disorder requiring renal replacement therapy
7. Patients with a life expectancy of less than one year for whatever clinical condition
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Assessment of safety: this include evaluation of general safety (blood pressure, heart rate, monitoring of the patient during infusion, laboratory tests, urinalysis)<br>2. Pharmacokinetics: PSD-04 plasma concentrations during study days<br>3. Pharmacodynamics (primary): echocardiography (ECG): left ventricular diastolic function parameters and ejection fraction
- Secondary Outcome Measures
Name Time Method Pharmacodynamics (secondary):<br>1. Biochemical markers for myocardial damage<br>2. ECG parameters