ocal HER-O: A study of local therapy for the treatment of brain metastases from Human Epidermal Growth Factor Receptor Type 2 (HER2) positive breast cancer.
- Conditions
- Metastatic HER2 positive breast cancer - brain metastasesCancer - BreastCancer - Brain
- Registration Number
- ACTRN12616001265460
- Lead Sponsor
- Trans Tasman Radiation Oncology Research Group (TROG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 25
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
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method