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 designOpen phase III randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleHER-PCI: prospective randomised clinical trial testing the role of prophylactic cranial irradiation in patients treated with Trastuzmab (Herceptin) for metastatic breast cancer
Study acronymHER-PCI
Study objectivesDoes 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) studiedMetastatic breast cancer
InterventionControl 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 typeDrug
Pharmaceutical study type(s)
PhasePhase III
Drug / device / biological / vaccine name(s)Trastuzmab (Herceptin)
Primary outcome measureThe incidence of symptomatic brain metastases
Secondary outcome measures1. Survival
2. Cerebral toxicity and quality of life
Overall study start date01/11/2006
Completion date30/10/2010

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexFemale
Target number of participants390
Key inclusion criteria1. 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 criteria1. 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 enrolment01/04/2007
Date of final enrolment01/03/2010

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 logo "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 shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planNot 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.