Study Investigating the Role of Routine Screening and Molecular Characterisation of Brain Metastasis in the Management of High-risk Metastatic Breast Cancer

NCT06728150 | Not Yet Recruiting

• 1 other identifier: Project 331/22
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to improve 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. However, there is emerging evidence suggesting that patients diagnosed without symptoms of brain metastases may have a better outcome than those with symptoms such as headache, vomiting and weakness. In current practice, if signs and symptoms suggestive of brain metastases are to develop, then the doctor will arrange imaging of the brain, which may be a computerised tomography (CT scan) and/or a magnetic resonance imaging (MRI) scan. Should brain metastasis be detected, local radiotherapy, chemotherapy or targeted treatments will be offered. When initially diagnosed with metastatic or advanced breast cancer, participant will or would have undergone a brain scan by either MRI or CT during normal standard full-body CT scan (chest, abdomen and pelvis) imaging. In this study, each time participants have a regular full-body CT scans to assess treatment progress, they will also have an additional CT scan of the brain. Participants will have a total of 12 extra brain scans, with scans taking place every three months for the first 2 years, and every 6 months for the following years. These scans will occur at the same location as your current treatment. There will be no extra costs involved in the study and participants will be in the study for 4 years and following their follow-up details will be collected from medical records. Some participants who develop brain metastases during the followup will have neurosurgery to remove these metastases. The investigators will collect either fresh or archived tissues and a cerebrospinal fluid (CSF) sample at the time of surgery from those patients. If the treating investigators do not think neurosurgery is an option, they will ask participants to have a lumbar puncture for the collection of CSF. The purpose of this optional CSF collection is to take a liquid biopsy to check for markers (or biomarkers) potentially expressed by the breast cancer tumour cells in the brain. Participants will also be asked to provide a blood sample as well as old tumour from breast surgery (other metastatic tumour tissue). The information obtained from this component of the study will not impact a parcipants current management, but it will help researchers to develop better treatments for breast cancer brain metastases in the future.

Conditions

Breast Cancer Metastatic; Brain Metastasases

Keywords

Breast cancer brain metastases

Outcome Measures

Primary Outcomes (1)

• Incidence of screen-detected asymptomatic brain metastasis.

  CT scan of the brain used to determine evidence of new metastases.

  12 months

Secondary Outcomes (6)

• Incidence of symptomatic brain metastases

  Though to study completion, an average of 1 year

• Progression free survival

  Though to study completion, an average of 1 year

• Overall survival

  Though to study completion, an average of 1 year

• Number of surgical resections

  Though to study completion, an average of 1 year

• Rate of stereotactic radiotherapy

  Though to study completion, an average of 1 year

Interventions

computerized tomography RADIATION

The patients will have 3 monthly CT scans of the brain for 2 years and 6 monthly CT scans for 2 years for total of 4 years.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a diagnosis of metastatic breast cancer.

You may qualify if:

• Metastatic breast cancer with visceral, nodal or bone metastasis
• Human epidermal growth factor type2 (HER2-positive disease)
• Triple negative breast cancer (TNBC) with metastatic disease
• Oestrogen Receptor Positive disease (ER-positive disease) after second-line therapy and cyclin dependent kinase 4/6 inhibitors (CDK4/6 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 MRI confirmation) • Medicare Eligible

You may not qualify if:

• Symptomatic brain metastasis
• Inability to provide consent
• Inadequate organ function
• Pregnancy.

Sponsors & Collaborators

• Monash University: lead
• The Alfred: collaborator
• Breast Cancer Trials, Australia and New Zealand: collaborator

Study Sites (1)

The Alfred

Melbourne, Victoria, Australia

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tissues form past breast cancer or brain metastases tissues and blood.

Study Officials

• Mahesh Iddawela, MBBS FRACP PhD

  Associate Professor and Medical Oncologist

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mahesh Iddawela, MBBS FRACP PhD

CONTACT

61351738000; mahesh.iddawela@monash.edu

Neethu Namia, BSc

CONTACT

61 3 9076 9625; neeth.namia@alfred.org.au

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 13, 2024
• First Posted: December 11, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: December 11, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After 4 years
• Access Criteria: With ethics approval from The Alfred ethics committee.

Locations

AU (1)