Breast cancer patients.
Conditions
Interventions
The patients are either randomised in the PCD-04 group or in the placebo group.
Sponsors
LTT Bio-Pharma Co.
Ltd.Atago Green Hills MORI Tower 26F2-5-1, Atago
Minato-ku, Tokyo
105-6201 Japan
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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 1 hr; 4. Patients with (a history of) malignant disease other than carcinoma of the breast; 5. Patients with hepatic disorders evidenced by elevated transamines above 3 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 1 year for whatever clinical condition.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of safety: this include evaluation of general safety (Blood pressure, heartrate, monitoring of the patient during infusion, laboratory tests, urinalysis). Pharmacokinetics: PSD-04 plasma concentrations during study days. Pharmacodynamics (primary): Echocardiography: Left ventricular diastolic function parameters and ejection fraction. | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacodynamics (secondary): 1. Biochemical markers for myocardial damage; 2. ECG parameters. | — |
Contacts
Public ContactF.J.F. Broeyer
Center for Human Drug Research, Zernikedreef 10
Outcome results
None listed