No registrations found.
ID
Source
Brief title
Health condition
Breast cancer patients.
Sponsors and support
Ltd.Atago Green Hills MORI Tower 26F2-5-1, Atago
Minato-ku, Tokyo
105-6201 Japan
Intervention
Outcome measures
Primary outcome
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 outcome
Pharmacodynamics (secondary):
1. Biochemical markers for myocardial damage;
2. ECG parameters.
Background summary
N/A
Study objective
Subjects in the PCD-04 arm will show less anthracyclin-induced cardiotoxicty then subjects in the placebo arm.
Study design
N/A
Intervention
The patients are either randomised in the PCD-04 group or in the placebo group.
Zernikedreef 10
F.J.F. Broeyer
Zernikedreef 10
Leiden 2333 CL
The Netherlands
+31 (0)71 5246431
fbroeyer@chdr.nl
Zernikedreef 10
F.J.F. Broeyer
Zernikedreef 10
Leiden 2333 CL
The Netherlands
+31 (0)71 5246431
fbroeyer@chdr.nl
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL199 |
| NTR-old | NTR236 |
| Other | : N/A |
| ISRCTN | ISRCTN56637853 |