CompletedNot Applicable

A Study of Local Therapy for the Treatment of Brain Metastases From HER2 Positive Breast Cancer

Australia25 participantsStarted 2017-11-20

Plain-language summary

This study aims to show that brain metastases from Human Epidermal Growth Factor Receptor Type 2 (HER2) positive breast cancers are able to be controlled by local therapies, Stereotactic Radiosurgery (SRS) and/or Neurosurgery (NS), without the need for Whole Brain Radiotherapy (WBRT).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 18 years or older * Metastatic HER2 positive breast cancer * 1-5 synchronous brain metastases * At least one metastases requiring treatment * Maximum volume of any single PTV \<10cm3 * 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 Criteria: * 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 30mm in size and unable to be resected * Leptomeningeal disease * Pregnant or breastfeeding

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

to assess the percentage of patients treated with whole brain radiotherapy within 12 months after completion of local therapy

Timeframe: 12 months after completion of local therapy

Trial details

NCT IDNCT02898727

SponsorTrans Tasman Radiation Oncology Group

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-07-22

View on ClinicalTrials.gov More Breast Neoplasms trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.