Condition category
Cancer
Date applied
24/08/2006
Date assigned
13/09/2006
Last edited
27/11/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Peter Canney

ORCID ID

Contact details

Beatson West of Scotland Cancer Centre
1053 Great Western Road
Glasgow
G12 0YN
United Kingdom

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 measures

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

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

http://www.nhsgg.org.uk/content/default.asp

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

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

Results - basic reporting

Publication summary

2015 results in http://www.ncbi.nlm.nih.gov/pubmed/25976296

Publication citations

Additional files

Editorial Notes

26/10/2015: Ten additional trial participating centres have been added to the record.