A double-blind, placebo-controlled study to assess the safety and efficacy of PCD-04 as a protective agent against anthracycline-induced cardiotoxicity

ISRCTN	ISRCTN56637853
DOI	https://doi.org/10.1186/ISRCTN56637853
Protocol serial number	N/A
Sponsor	LTT Bio-Pharma (Japan)
Funder	Not provided at time of registration

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr F.J.F. Broeyer
Scientific

Zernikedreef 10
Leiden
2333 CL
Netherlands

Phone	+31 (0)71 5246431
Email	fbroeyer@chdr.nl

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	A double-blind, placebo-controlled study to assess the safety and efficacy of PCD-04 as a protective agent against anthracycline-induced cardiotoxicity
Study acronym	PROTACMI
Study objectives	Subjects in the PCD-04 arm will show less anthracyclin-induced cardiotoxicity then subjects in the placebo arm.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Breast cancer
Intervention	The patients are either randomised in the PCD-04 group or in the placebo group.
Intervention type	Other
Primary outcome measure(s)	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
Key secondary outcome measure(s)	Pharmacodynamics (secondary): 1. Biochemical markers for myocardial damage 2. ECG parameters
Completion date	01/12/2005

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	72
Total final enrolment	80
Key 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
Key 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
Date of first enrolment	16/09/2003
Date of final enrolment	01/12/2005

Zernikedreef 10

Leiden
2333 CL
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/11/2014	07/01/2021	Yes	No

07/01/2021: Publication reference and total final enrolment added.