Condition category
Cancer
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
10/03/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.ltt.co.jp/main_e.html

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

Publication citations

Additional files

Editorial Notes