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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer Metastatic; Brain Metastasases
• Intervention / Treatment: Radiation: computerized tomography

• Study Type: Observational
• Enrollment (Estimated): 45

Contacts and Locations

• Study Contact: Name: Mahesh Iddawela, MBBS FRACP PhD; Phone Number: 61351738000; Email: mahesh.iddawela@monash.edu
• Study Contact Backup: Name: Neethu Namia, BSc; Phone Number: 61 3 9076 9625; Email: neeth.namia@alfred.org.au

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia
      • The Alfred

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with a diagnosis of metastatic breast cancer.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of screen-detected asymptomatic brain metastasis.	CT scan of the brain used to determine evidence of new metastases.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of symptomatic brain metastases	CT scans of the brain	Though to study completion, an average of 1 year
Progression free survival	Time form entry into the study to brain metastases development	Though to study completion, an average of 1 year
Overall survival	Time form entry into the study to death	Though to study completion, an average of 1 year
Number of surgical resections	The number of patients who develop brain metastases having surgery	Though to study completion, an average of 1 year
Rate of stereotactic radiotherapy	The number of patients having stereotactic radiotherapy assesses using medical records	Though to study completion, an average of 1 year
Evaluation of the role of early treatment on intracranial disease control	Time form initial surgical or radiotherapy or observation to progression of disease	Though to study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Monash University
• Collaborators: The Alfred; Breast Cancer Trials, Australia and New Zealand
• Investigators: Principal Investigator: Mahesh Iddawela, MBBS FRACP PhD, Associate Professor and Medical Oncologist

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: November 13, 2024
• First Submitted That Met QC Criteria: December 10, 2024
• First Posted (Estimated): December 11, 2024

Study Record Updates

• Last Update Posted (Estimated): December 11, 2024
• Last Update Submitted That Met QC Criteria: December 10, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Breast cancer brain metastases
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pathologic Processes; Neoplasms by Site; Neoplasms; Neoplastic Processes; Skin Diseases; Breast Diseases; Nervous System Neoplasms; Central Nervous System Neoplasms; Breast Neoplasms; Neoplasm Metastasis; Brain Neoplasms
• Other Study ID Numbers: Project 331/22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The details of the protocol, patient information sheet, de-identified data and analysis
• IPD Sharing Time Frame: After 4 years
• IPD Sharing Access Criteria: With ethics approval from The Alfred ethics committee.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No