PRIMROSE Audit: A multicentre audit of care provided to patients with breast cancer involving the brain in the UK

ISRCTN	ISRCTN18204314
DOI	https://doi.org/10.1186/ISRCTN18204314
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	Nil known
Sponsor	University of Liverpool
Funder	Daiichi-Sankyo

Submission date: 13/08/2020
Registration date: 19/08/2020
Last edited: 07/10/2020

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Breast cancer is one of the most common cancers that can spread to the brain. We also know that there are different types of breast cancer and some of these spread more easily to the brain than others. Secondary cancer in the brain is usually deadly and reduces the quality of life in patients.
We wish to understand how breast cancer patients present with disease involving the brain, how they are managed across the UK nor what impact it has on their survival. With this knowledge, we will be able to improve the services and care for these patients.

Who can participate?
Records from patients aged 16 years or older, who suffer from breast cancer with central nervous system involvement.

What does the study involve?
The PRIMROSE audit will involve data that is routinely collected from patients diagnosed with breast cancer involving the brain between January 2020 and December 2021. The collected data will be anonymised before it can be used for research. The data will be collected by clinicians normally involved in the care of these patients.

What are the possible benefits and risks of participating?
None

Where is the study run from?
University of Liverpool

When is the study starting and how long is it expected to run for?
January 2020 to July 2022

Who is funding the study?
Daiichi-Sankyo (Japan)

Who is the main contact?
Professor Carlo Palmieri, c.palmieri@liv.ac.uk

Contact information

Prof Carlo Palmieri
Public

Department of Molecular and Clinical Cancer Medicine
Institute of Translational Medicine
Sherrington Building, Ashton Street
University of Liverpool
Liverpool
L69 3GE
United Kingdom

ORCID ID	0000-0001-9496-2718
Phone	+44 (0)151 706 3616
Email	c.palmieri@liv.ac.uk

Study information

Primary study design	Observational
Study design	Prospective observational multi centre audit
Secondary study design	Cohort study
Study type	Participant information sheet
Scientific title	PRIMROSE Audit: A Prospective Multi-Centre Project to Assess the Presentation, Management, and Outcomes of Patients with CNS Disease Secondary to Breast Cancer
Study acronym	PRIMROSE
Study objectives	To capture the local and regional variation in the presentation, diagnosis and management of patients with CNS disease secondary to breast cancer in the UK
Ethics approval(s)	The PRIMROSE audit does not require research ethics committee (REC) review as it is an audit, and not a research project. This has been confirmed using the Health Research Authority (HRA) decision tools and as advised on the tools, we have sought further guidance from an HRA Approvals Specialist. Documents confirming the outcome of these are available on request. Local audit approvals will need to be obtained, with a supervising named consultant, if the unit lead is a trainee.
Health condition(s) or problem(s) studied	Central Nervous System disease secondary to breast cancer
Intervention	Patients' records will be reviewed to collect routine care data on demographic information, clinicopathological features and treatment of primary breast cancer, information relating to disease recurrence, prior cancer treatment for non-CNS metastatic disease (if applicable), surgical and radiotherapy treatment of CNS disease (if applicable), current anti-cancer treatment and concomitant medication, cancer-related outcomes
Intervention type	Other
Primary outcome measure(s)	Overall survival from initial diagnosis of CNS involvement secondary breast cancer measured using patient records at a single time point.
Key secondary outcome measure(s)	Measured at a single time point: 1. Number of cases of metastatic breast cancer involving the CNS presenting in UK centres per year measured using patient records 2. Current practice in UK centres regarding the diagnosis and management of CNS disease secondary to breast cancer in relation to national and international guidelines: 2.1. Prior cancer treatment for non-CNS metastatic disease 2.2. Surgical and radiotherapy treatment of CNS disease 2.3. Current anti-cancer treatment and concomitant medications 3. Outcomes of patients treated for CNS involvement secondary to breast cancer in UK centres: 3.1. Time to progression from surgery, radiotherapy or systemic therapy, defined as time from commencement of treatment for CNS disease to disease progression and site of progression 3.2. Overall survival measured as the time from diagnosis of recurrent disease until death of any cause 3.3. Cause of death: Progressive CNS disease versus progressive disease at other sites
Completion date	31/12/2022

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	100
Key inclusion criteria	1. ≥16 years of age 2. Histologically and/or cytologically confirmed breast cancer with CNS involvement, as defined as having one or more of the following: 2.1. Metastases to the brain parenchyma 2.2. Metastases to the leptomeninges 2.3. Paraneoplastic Neurological Disorders
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	01/08/2020
Date of final enrolment	31/07/2022

Locations

Countries of recruitment

United Kingdom
England
Scotland

Study participating centres

Queen Elizabeth Hospital

Mindelsohn Way
Edgbaston
Birmingham
B15 2WB
United Kingdom

Southampton General Hospital

Tremona Road
Southampton
Hampshire
Southampton
SO16 6YD
United Kingdom

The Christie NHS Foundation Trust

Wilmslow Rd
Manchester
M20 4BX
United Kingdom

University of Liverpool

Foundation Building
Brownlow Hill
Liverpool
L69 3BX
United Kingdom

Queen Elizabeth University Hospital

NHS Greater Glasgow and Clyde
1345 Govan Rd
Glasgow
G51 4TF
United Kingdom

St. Mary's Hospital

Imperial College Healthcare NHS Trust
Praed Street
London
W2 1NY
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
IPD sharing plan	The current data sharing plans for this study are unknown and will be available at a later date.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

07/10/2020: The following changes have been made:
1. The recruitment end date has been changed from 31/07/2021 to 31/07/2022.
2. The overall trial end date has been changed from 31/07/2022 to 31/12/2022.
3. The intention to publish date has been changed from 31/12/2022 to 01/03/2023.
20/08/2020: The trial participating centre 'St. Mary's Hospital' was added.
19/08/2020: Trial’s existence confirmed by Daiichi-Sankyo