Metastatic breast cancer Cancer Metastatic breast cancer
Conditions
Interventions
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
Sponsors
NHS Greater Glasgow and Clyde (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of symptomatic brain metastases | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Survival 2. Cerebral toxicity and quality of life | — |
Countries
United Kingdom
Outcome results
None listed