Trial purpose
Cancer treatment
Tumor type
Breast
Age
18+
Clinical summary
Summary
This study is aiming to recruit 50 participants that have HER2 positive metastatic breast cancer with 1-5 synchronous brain metastases, with at least one met requiring treatment. The purpose of the study is to determine; 1. How likely the tumour/s are controlled after treatment with local therapies Neurosurgery (NS) and/or Stereotactic Radiosurgery (SRS). 2. How likely is it that other tumours develop at new sites in the brain when no Whole Brain Radiotherapy (WBRT) is given. Study Details: For patients who have HER2 positive breast cancer which has spread to the brain (metastasised), the main treatment options for these brain metastasis are Whole Brain Radiotherapy (WBRT), Stereotactic Radiosurgery (SRS) and Neurosurgery (NS) Participants will be given either SRS or surgery or a combination of both depending on the particular features of each tumour. All participants will be followed up at regular 3 monthly intervals for 12 months after completing thier trial treatment (i.e. from the day of their last SRS treatment or of neurosurgery, the latter of the two). At each follow-up visit they will have a clinic visit with the study doctor who to assess any symptoms, record current medications and/or surgeries, monitor their brain metastasis, have a blood test and imaging (CT scan, a bone scan and MRI brain).
Conditions
This trial is treating people with brain metastases from HER 2+ breast cancer
Eligibility
Inclusion
- 18 years or older
- metastatic HER2 positive breast cancer
- 1-5 synchonous brain metastases (At least 1 lesion must require treatment with surgery or SRS, Maximum volume of any single PTV <10cm3 and Summated volume of all lesions to be treated with SRS is < 15cm3. If a lesion is too small for treatment and will be observed, then its volume is not included in this summation).
- ECOG 0-2
- Absent or stable extracranial disease or active extracranial disease that is likely to be controlled with further HER-2 targeted therapy.
- Receiving systemic HER2 targeted therapy, or planned to receive within 4 weeks of completion of brain metastasis treatment
- Able to undergo MRI scanning
Exclusion
- Previous treatment to the target brain metastases (excluding surgery within 6 weeks of registration)
- Previous whole brain radiotherapy (WBRT)
- Any brain metastasis that is greater than 40mm in size and unable to be resected
- Leptomeningeal disease
- Pregnant or breastfeeding
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ANZCTR *. View further details about this trial on the registry via the links below:
Trial sponsor
Trans Tasman Radiation Oncology Group (TROG)
Scientific Title
A Phase II study of local therapy only (stereotactic radiosurgery and/or surgery) for treatment of up to 5 brain metastases from HER2 positive Breast Cancer
Get Support
You might find it helpful to speak to someone who has 'been there before'. Our Peer Connect program can provide one-on-one phone support from someone who understands what you're going through and has clinical trials experience.
Know more about Peer Connect
If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council to speak with an experienced health professional on 13 11 20.
Get support
Learn more about clinical trials through this collection of resources in languages other than English.
View information