Contact information
Type
Scientific
Primary contact
Dr F.J.F. Broeyer
ORCID ID
Contact details
Zernikedreef 10
Leiden
2333 CL
Netherlands
+31 (0)71 5246431
fbroeyer@chdr.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
PROTACMI
Study hypothesis
Subjects in the PCD-04 arm will show less anthracyclin-induced cardiotoxicity then subjects in the placebo arm.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Breast cancer
Intervention
The patients are either randomised in the PCD-04 group or in the placebo group.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Assessment of safety: this include evaluation of general safety (blood pressure, heart rate, monitoring of the patient during infusion, laboratory tests, urinalysis)
2. Pharmacokinetics: PSD-04 plasma concentrations during study days
3. Pharmacodynamics (primary): echocardiography (ECG): left ventricular diastolic function parameters and ejection fraction
Secondary outcome measures
Pharmacodynamics (secondary):
1. Biochemical markers for myocardial damage
2. ECG parameters
Overall trial start date
16/09/2003
Overall trial end date
01/12/2005
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
72
Participant 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 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
Recruitment start date
16/09/2003
Recruitment end date
01/12/2005
Locations
Countries of recruitment
Netherlands
Trial participating centre
Zernikedreef 10
Leiden
2333 CL
Netherlands
Sponsor information
Organisation
LTT Bio-Pharma (Japan)
Sponsor details
26th Floor
Atago Green Hills MORI Tower
2-5-1
Atago
Minato-ku
Tokyo
105-6201
Japan
Sponsor type
Industry
Website
Funders
Funder type
Not defined
Funder name
Not provided at time of registration
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary