HER-PCI: prospective randomised clinical trial testing the role of prophylactic cranial irradiation in patients treated with Trastuzmab (Herceptin) for metastatic breast cancer

ISRCTN	ISRCTN64624715
DOI	https://doi.org/10.1186/ISRCTN64624715
ClinicalTrials.gov number	NCT00639366
Secondary identifying numbers	N/A

Submission date: 24/08/2006
Registration date: 13/09/2006
Last edited: 27/11/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

http://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-to-see-if-radiotherapy-can-prevent-breast-cancer-spreading-to-the-brain-in-women-treated-with-herceptin

Contact information

Dr Peter Canney
Scientific

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

Study information

Study design	Open phase III randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study acronym	HER-PCI
Study objectives	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(s)	West Glasgow Ethics Committee 1 on the 3rd October 2006 (ref: 06/S0703/108)
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Phase III
Drug / device / biological / vaccine name(s)	Trastuzmab (Herceptin)
Primary outcome measure	The incidence of symptomatic brain metastases
Secondary outcome measures	1. Survival 2. Cerebral toxicity and quality of life
Overall study start date	01/11/2006
Completion date	30/10/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	390
Key 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
Key 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
Date of first enrolment	01/04/2007
Date of final enrolment	01/03/2010

Locations

Countries of recruitment

England
Scotland
United Kingdom

Study participating centres

Beatson West of Scotland Cancer Centre

1053 Great Western Road
Glasgow
G12 0YN
United Kingdom

Ninewells Hospital

Dundee
DD1 9SY
United Kingdom

Great Western Hospital,

Marlborough Road
Swindon
SN3 6BB
United Kingdom

Western General Hospital

Crewe Road South
Edinburgh
EH4 2XU
United Kingdom

Wishaw General Hospital

50 Netherton Street
Wishaw
ML2 0DP
United Kingdom

Christie Hospital

550 Wilmslow Road
Manchester
M20 4BX
United Kingdom

Weston Park Hospital

Whitham Road
Sheffield
S10 2SJ

Crosshouse Hospital

Kilmarnock Road
Crosshouse
Kilmarnock
KA2 0BE
United Kingdom

St James University Hospital

Beckett Street
Leeds
LS9 7TF
United Kingdom

Southend Hospital

Prittlewell Chase
Westcliff-on-Sea
Southend
SS0 0RY
United Kingdom

Royal Liverpool University Hospital

Prescot Street
Liverpool
L7 8XP
United Kingdom

Sponsor information

NHS Greater Glasgow and Clyde (UK)
Government

Research and Development Central Office
The Tennent Institute
1st Floor, Western Infirmary
38 Church Street
Glasgow
G11 6NT
United Kingdom

Website	http://www.nhsgg.org.uk/content/default.asp
"ROR"	https://ror.org/05kdz4d87

Funders

Funder type

Charity

Cancer Research UK
Private sector organisation / Other non-profit organizations

Alternative name(s): CR_UK, Cancer Research UK - London, CRUK
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/08/2015		Yes	No

Editorial Notes

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