Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00639366
Protocol/serial number
N/A
Study information
Scientific title
HER-PCI: prospective randomised clinical trial testing the role of prophylactic cranial irradiation in patients treated with Trastuzmab (Herceptin) for metastatic breast cancer
Acronym
HER-PCI
Study hypothesis
Does Prophylactic Cranial Irradiation (PCI) delivering 30 Gy in ten fractions significantly reduce the incidence of symptomatic brain metastases in patients treated with Trastuzamab (Herceptin) for metastatic breast cancer?
Please note that as of 12/09/2008, the actual start date of this trial was 28th March 2007. At this time, the sponsor details were also updated. The previous sponsor was Greater Glasgow Health Board (UK).
Ethics approval
West Glasgow Ethics Committee 1 on the 3rd October 2006 (ref: 06/S0703/108)
Study design
Open phase III randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Metastatic breast cancer
Intervention
Control arm: baseline Magnetic Resonance Imaging (MRI) of brain is required.
Experimental arm: baseline MRI of brain is required. PCI will be delivered to the whole brain giving 30 Gy in ten fractions daily. PCI will be deferred on any day that chemotherapy or Trastuzemab is administered.
Intervention type
Drug
Phase
Phase III
Drug names
Trastuzmab (Herceptin)
Primary outcome measure
The incidence of symptomatic brain metastases
Secondary outcome measures
1. Survival
2. Cerebral toxicity and quality of life
Overall trial start date
01/11/2006
Overall trial end date
30/10/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Histologically proven breast carcinoma which demonstrates HER2 protein level 3+ positivity on Immunohistochemistry (IHC) or level 2+ over-expression and Fluorescence In Situ Hybridisation (FISH) test demonstrating C-erB2 gene amplification
2. Metastatic disease or locally advanced disease
3. Female
4. Aged over 18 years
5. Eastern Cooperative Oncology Group (ECOG) performance status less than two
6. Patients must a-priori be suitable for Herceptin with or without chemotherapy in terms of bone marrow, hepatic and renal function
7. Signed, written informed consent
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
390
Participant exclusion criteria
1. Prior cranial radiation
2. Prior neurosurgery
3. Known or suspected brain metastases (as defined by the presence of any of the following key symptoms:
3.1. Headache
3.2. Nausea and/or vomiting
3.3. Clinical signs of raised intracranial pressure
3.4. Seizures
3.5. Focal symptoms
3.6. Cognitive dysfunction
3.7. Affective disorder
3.8. Central nervous system [CNS] disease)
4. Previous history of cerebrovascular disease or neurological disorder including seizures
Recruitment start date
01/04/2007
Recruitment end date
01/03/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Beatson West of Scotland Cancer Centre
1053 Great Western Road
Glasgow
G12 0YN
United Kingdom
Trial participating centre
Ninewells Hospital
Dundee
DD1 9SY
United Kingdom
Trial participating centre
Great Western Hospital,
Marlborough Road
Swindon
SN3 6BB
United Kingdom
Trial participating centre
Western General Hospital
Crewe Road South
Edinburgh
EH4 2XU
United Kingdom
Trial participating centre
Wishaw General Hospital
50 Netherton Street
Wishaw
ML2 0DP
United Kingdom
Trial participating centre
Christie Hospital
550 Wilmslow Road
Manchester
M20 4BX
United Kingdom
Trial participating centre
Weston Park Hospital
Whitham Road
Sheffield
S10 2SJ
Trial participating centre
Crosshouse Hospital
Kilmarnock Road
Crosshouse
Kilmarnock
KA2 0BE
United Kingdom
Trial participating centre
St James University Hospital
Beckett Street
Leeds
LS9 7TF
United Kingdom
Trial participating centre
Southend Hospital
Prittlewell Chase
Westcliff-on-Sea
Southend
SS0 0RY
United Kingdom
Trial participating centre
Royal Liverpool University Hospital
Prescot Street
Liverpool
L7 8XP
United Kingdom
Sponsor information
Organisation
NHS Greater Glasgow and Clyde (UK)
Sponsor details
Research and Development Central Office
The Tennent Institute
1st Floor
Western Infirmary
38 Church Street
Glasgow
G11 6NT
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit organizations
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Available on request
Basic results (scientific)
Publication list
2015 results in http://www.ncbi.nlm.nih.gov/pubmed/25976296