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Trial registered on ANZCTR


Registration number
ACTRN12624001395527
Ethics application status
Approved
Date submitted
9/10/2024
Date registered
26/11/2024
Date last updated
26/11/2024
Date data sharing statement initially provided
26/11/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Study investigating the role of imaging for brain metastases in advanced breast cancer.
Scientific title
Study investigating the role of routine screening and molecular characterisation of brain metastasis in the management of high-risk metastatic breast cancer in patients 18 or older.
Secondary ID [1] 313357 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 335437 0
Metastatic cancer 335438 0
Brain Cancer 335854 0
Condition category
Condition code
Cancer 332280 332280 0 0
Brain
Cancer 332428 332428 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Screening for brain metastases using Computerised Tomography (CT scans).
The patients will have 3 monthly CT scans of the brain for 2 years and then 6 monthly for 2 years. This will be organised by the oncology team and will last around 20 minutes for the procedure and will be undertaken by the radiographers in imaging units in collaboration with the radiologists. These will happen at the time of the routine scans undertaken at the time other scans are done to evaluate response to treatment. The clinical trials team will, ensure that the scans are carried out at the appropriate times and monitored when in the study.. The patient will be in the study for 4 years.
Intervention code [1] 329727 0
Early detection / Screening
Comparator / control treatment
Historical Controls from 2000 to 2025 treated for breast cancer and developed brain metastases will be used for comparison and will be identified using the medical records at Alfred Health.
Control group
Historical

Outcomes
Primary outcome [1] 339597 0
Incidence of screen-detected asymptomatic brain metastasis.
Timepoint [1] 339597 0
3 monthly for 2 years as the current data suggest that the brain metastases are commonly seen in the first 2 years. The scans will be undertaken 6 monthly for 2 years as the incidence of brain metastases decreases. The Primary Outcome will be assessed at the end of 4 years.
Secondary outcome [1] 441324 0
-Number of surgical resections
Timepoint [1] 441324 0
3 monthly for 2 years and 6 monthly for 2 years and overall outcome assessed at 4 years.
Secondary outcome [2] 441325 0
-Rate of stereotactic radiotherapy
Timepoint [2] 441325 0
3 monthly for 2 years and 6 monthly for 2 years and overall outcome assessed at 4 years.
Secondary outcome [3] 441326 0
-Progression free survival
Timepoint [3] 441326 0
CT scans 3 monthly for 2 years and 6 monthly for 2 years and overall outcome assessed at 4 years.
Secondary outcome [4] 441327 0
Overall survival
Timepoint [4] 441327 0
3 monthly for 2 years and 6 monthly for 2 years and overall outcome assessed at 4 years.

Eligibility
Key inclusion criteria
• Metastatic breast cancer with visceral, nodal or bone metastasis
• Human Epidermal Growth Factor Receptor 2-positive disease
- Triple Negative disease with metastatic disease
-Oestrogen Receptor Positive disease after second-line therapy and cyclin dependent kinase (CDK) 4/6 inhibitors, plus more than two sites of bone metastasis or visceral metastasis
- Diagnosis of metastatic disease in the last 3 months and free of symptoms or disease (with
brain Magnetic Resonance Imaging confirmation)
- Medicare Eligible
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
-symptomatic brain metastasis
-inability to provide consent
-inadequate organ function
-pregnancy.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Patient with metastatic breast cancer will be invited to participate in the study and all patients will undergo CT brain imaging.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Single-arm study of 45 patients to evaluate the acceptability and collect further information on incidence of brain metastases.
Total of 45 patients (including 10% drop-out) and will include (twenty TNB, twenty HER-2 and five ER+ patients. Assuming expected relapse overall 10 patients with TNB , 8 patients with HER-2 , and 5 patients with ER+ breast cancer will develop brain metastases.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2024
Actual
Date of last participant enrolment
Anticipated
31/12/2025
Actual
Date of last data collection
Anticipated
31/12/2029
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 27205 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 43289 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 317603 0
Charities/Societies/Foundations
Name [1] 317603 0
Breast Cancer Trials
Country [1] 317603 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Country
Australia
Secondary sponsor category [1] 320069 0
Government body
Name [1] 320069 0
Alfred Health
Address [1] 320069 0
Country [1] 320069 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316306 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 316306 0
https://www.alfredhealth.org.au/research/ethics-research-governance
Ethics committee country [1] 316306 0
Australia
Date submitted for ethics approval [1] 316306 0
30/09/2022
Approval date [1] 316306 0
06/09/2024
Ethics approval number [1] 316306 0

Summary
Brief summary
The purpose of this study is to improve the outcome of breast cancer patients who develop brain metastases. This will investigate the benefits of early detection of brain metastases using brain imaging. In patients diagnosed and currently being treated for advanced or metastatic breast cancer, current guidelines do not recommend routine brain imaging.

Who is it for?
You may be eligible to participate in this study if you are a female age 18 or over with diagnosed with metastatic breast cancer, ER-positive disease after second-line therapy and CDK4/6 inhibitors, plus more than two sites of bone metastasis or visceral metastasis as well as triple negative (TNBC) and human epidermal growth factor-2 positive (HER-2) patients.

Study details
Study participants will be screened for brain metastases using Computerised Tomography (CT scans) and patients will have 3 monthly CT scans of the brain for 2 years and then 6 monthly for 2 years. This will be organised by the oncology team and will last around 20 minutes for the procedure and will be undertaken by the radiographers in imaging units in collaboration with the radiologists, Throughout the study’s period, participant’s medical records and CT scan results will be reviewed and compared to historical data.

It is hoped that the result from this study will help to determine whether routine brain imaging should be offered to patients with breast cancer.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 137470 0
A/Prof Mahesh Iddawela
Address 137470 0
Paula Fox Melanoma & Cancer Centre, Alfred Health, 545 St Kilda Rd, Melbourne VIC 3004
Country 137470 0
Australia
Phone 137470 0
+61 3 9076 9625
Fax 137470 0
Email 137470 0
[email protected]
Contact person for public queries
Name 137471 0
Neethu Namia
Address 137471 0
Paula Fox Melanoma & Cancer Centre, Allfred Health, 545 St Kilda Rd, Melbourne VIC 3004
Country 137471 0
Australia
Phone 137471 0
+61 3 9076 9625
Fax 137471 0
Email 137471 0
[email protected]
Contact person for scientific queries
Name 137472 0
A/Prof Mahesh Iddawela
Address 137472 0
Paula Fox Melanoma & Cancer Centre, Alfred Health, 545 St Kilda Rd, Melbourne VIC 3004
Country 137472 0
Australia
Phone 137472 0
+61 3 9076 2828
Fax 137472 0
Email 137472 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.