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 (NCT) | NCT00639366 |
| Protocol serial number | N/A |
| Sponsor | NHS Greater Glasgow and Clyde (UK) |
| Funder | Cancer Research UK |
- 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
Contact information
Dr Peter Canney
Scientific
Scientific
Beatson West of Scotland Cancer Centre
1053 Great Western Road
Glasgow
G12 0YN
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Open phase III randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Trastuzmab (Herceptin) |
| Primary outcome measure(s) |
The incidence of symptomatic brain metastases |
| Key secondary outcome measure(s) |
1. Survival |
| Completion date | 30/10/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 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
- United Kingdom
- England
- Scotland
Study participating centres
Beatson West of Scotland Cancer Centre
1053 Great Western Road
Glasgow
G12 0YN
United Kingdom
Glasgow
G12 0YN
United Kingdom
Ninewells Hospital
Dundee
DD1 9SY
United Kingdom
DD1 9SY
United Kingdom
Great Western Hospital,
Marlborough Road
Swindon
SN3 6BB
United Kingdom
Swindon
SN3 6BB
United Kingdom
Western General Hospital
Crewe Road South
Edinburgh
EH4 2XU
United Kingdom
Edinburgh
EH4 2XU
United Kingdom
Wishaw General Hospital
50 Netherton Street
Wishaw
ML2 0DP
United Kingdom
Wishaw
ML2 0DP
United Kingdom
Christie Hospital
550 Wilmslow Road
Manchester
M20 4BX
United Kingdom
Manchester
M20 4BX
United Kingdom
Weston Park Hospital
Whitham Road
Sheffield
S10 2SJ
Sheffield
S10 2SJ
Crosshouse Hospital
Kilmarnock Road
Crosshouse
Kilmarnock
KA2 0BE
United Kingdom
Crosshouse
Kilmarnock
KA2 0BE
United Kingdom
St James University Hospital
Beckett Street
Leeds
LS9 7TF
United Kingdom
Leeds
LS9 7TF
United Kingdom
Southend Hospital
Prittlewell Chase
Westcliff-on-Sea
Southend
SS0 0RY
United Kingdom
Westcliff-on-Sea
Southend
SS0 0RY
United Kingdom
Royal Liverpool University Hospital
Prescot Street
Liverpool
L7 8XP
United Kingdom
Liverpool
L7 8XP
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2015 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
26/10/2015: Ten additional trial participating centres have been added to the record.
