Breast NeoplasmsLocal HER-ONCT02898727
A Study of Local Therapy for the Treatment of Brain Metastases From HER2 Positive Breast Cancer
A study testing Local Therapy in people with Breast Neoplasms, run by Trans Tasman Radiation Oncology Group at 1 site in Australia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Local Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteAustralia
- Study dates
- 20 Nov 2017to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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).
Read the detailed description
For patients who have Human Epidermal Growth Factor Receptor Type 2 (HER2) positive breast cancer, which has metastasised to the brain, the main treatment options for these brain metastases are Whole Brain Radiotherapy (WBRT), Stereotactic Radiosurgery (SRS) and Neurosurgery (NS).
The purpose of the study is to determine:
- . How likely the tumours are controlled after treatment with local therapies Neurosurgery (NS) and/or Stereotactic Radiosurgery (SRS).
- . How likely is it that other tumours develop at new sites in the brain when no Whole Brain Radiotherapy (WBRT) is given.
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 metastasis requiring treatment.
The local treatment offered will be determined by the participant's doctor in consultation with the site multidisciplinary team and will be dependent on the size and location of the brain metastases. Each treatment will be performed by the specialist in that field, i.e. neurosurgeon and/or radiation oncologist.
Neurosurgery: The decision whether or not to recommend neurosurgery will be made independently of this research study. The surgery may be performed up to 6 weeks before participant being registered on the trial or up to 4 weeks after registration. The complexity and length of the surgery depends on the size and location of the tumour(s).
Sometimes stereotactic radiosurgery is required to be delivered to the cavity left after the metastasis has been removed (also known as a cavity boost). Timing of Cavity SRS is at the discretion of the treating team. SRS cavity boost must be given after registration and can be given up to 8 weeks after NS resection.
Stereotactic Radiosurgery: If the participant will be receiving stereotactic radiosurgery (either alone or in combination with neurosurgery), the Radiation Oncologist will organise for the participant to have a Radiotherapy planning. Treatment is to commence within 4 weeks of study registration.
The size, number and location of the brain metastasis will determine the dose and fractionation schedule of radiotherapy. Single metastasis, smaller than or equal to 2cm, may require 1 fraction. Alternately, multiple metastasis, metastasis in the brain stem, or those bigger than 2cm will required multiple fractions to treat. The dose range for the study is 20Gy/1 fraction to 24Gy/3 fractions. Each fraction is given on a separate day.
All participants will be followed up at 3 monthly intervals for 12 months after completing their trial treatment (i.e. from the day of their last SRS treatment or 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, bone scan and MRI brain).
- Conditions
- Breast Neoplasms
- Being tested
- Local Therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local TherapyOther
Neurosurgery: The decision whether or not to recommend neurosurgery will be made independently of this research study. The complexity and length of the surgery depends on the size and location of the tumour(s).
Stereotactic Radiosurgery: If the participant will be receiving stereotactic radiosurgery (either alone or in combination with neurosurgery), the Radiation Oncologist will organise for the participant to have a Radiotherapy planning. Single metastasis, smaller than or equal to 2cm, may require 1 fraction. Alternately, multiple metastasis, metastasis in the brain stem, or those bigger than 2cm will required multiple fractions to treat. The dose range for the study is 20Gy/1 fraction to 24Gy/3 fractions.
| Study group | Role | What they receive |
|---|---|---|
| Local Therapy | Other | The local therapy offered will be determined by the participant's doctor in consultation with the site multidisciplinary team and will be dependent on the size and location of the brain metastases.
Neurosurgery: The surgery may be performed up to 6 weeks before participant being registered on the trial or up to 4 weeks after registration.
Sometimes stereotactic radiosurgery is required to be delivered to the cavity left after the metastasis has been removed (Cavity Boost).
Stereotactic Radiosurgery: Treatment is to commence within 4 weeks of study registration. The size, number and location of the brain metastasis will determine the dose and fractionation schedule of radiotherapy. Receives: Other: Local Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
to assess the percentage of patients treated with whole brain radiotherapy within 12 months after completion of local therapy
Measured: 12 months after completion of local therapy
Secondary outcomes (7)
To describe distant brain failure incidence (overall and by number of treated metastases)
Measured: 12 months after completion of local therapy
To describe local brain failure incidence, at any site of SRS or surgery
Measured: 12 months after completion of local therapy
To describe extra-cranial failure incidence
Measured: 12 months after completion of local therapy
To describe the pattern of first failure
Measured: 12 months after completion of local therapy
To describe overall survival and cause of death (neurologic vs. non-neurologic)
Measured: 12 months after completion of local therapy
To describe adverse events and need for corticosteroids
Measured: Baseline and at 7-14 days, 3 months, 6 months, 9 months, and 12 months after completion of local therapy
To describe neurocognitive function using the mini-mental state examination (MMSE)
Measured: Baseline, and at 3, 6, 9, and 12 months after completion of local therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2016 (estimated)
- Study start20 Nov 2017
- Primary completion22 Jul 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trans Tasman Radiation Oncology Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claire Phillips, Dr, Principal investigator, Peter MacCallum Cancer Centre, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02898727
- Sponsor's protocol ID
- TROG 16.02
- Acronym
- Local HER-O
- Status last verified
- Nov 2022
- First submitted
- 7 Sep 2016
- Last updated
- 22 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02898727
- Acronym / sponsor ID
- Local HER-O / TROG 16.02
- Conditions
- Breast Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Trans Tasman Radiation Oncology GroupUniversity, hospital or other
- Study start
- 20 Nov 2017 (actual)
- Primary completion
- 22 Jul 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 13 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
For patients who have Human Epidermal Growth Factor Receptor Type 2 (HER2) positive breast cancer, which has metastasised to the brain, the main treatment options for these brain metastases are Whole Brain Radiotherapy (WBRT), Stereotactic Radiosurgery (SRS) and Neurosurgery (NS).
The purpose of the study is to determine:
- . How likely the tumours are controlled after treatment with local therapies Neurosurgery (NS) and/or Stereotactic Radiosurgery (SRS).
- . How likely is it that other tumours develop at new sites in the brain when no Whole Brain Radiotherapy (WBRT) is given.
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 metastasis requiring treatment.
The local treatment offered will be determined by the participant's doctor in consultation with the site multidisciplinary team and will be dependent on the size and location of the brain metastases. Each treatment will be performed by the specialist in that field, i.e. neurosurgeon and/or radiation oncologist.
Neurosurgery: The decision whether or not to recommend neurosurgery will be made independently of this research study. The surgery may be performed up to 6 weeks before participant being registered on the trial or up to 4 weeks after registration. The complexity and length of the surgery depends on the size and location of the tumour(s).
Sometimes stereotactic radiosurgery is required to be delivered to the cavity left after the metastasis has been removed (also known as a cavity boost). Timing of Cavity SRS is at the discretion of the treating team. SRS cavity boost must be given after registration and can be given up to 8 weeks after NS resection.
Stereotactic Radiosurgery: If the participant will be receiving stereotactic radiosurgery (either alone or in combination with neurosurgery), the Radiation Oncologist will organise for the participant to have a Radiotherapy planning. Treatment is to commence within 4 weeks of study registration.
The size, number and location of the brain metastasis will determine the dose and fractionation schedule of radiotherapy. Single metastasis, smaller than or equal to 2cm, may require 1 fraction. Alternately, multiple metastasis, metastasis in the brain stem, or those bigger than 2cm will required multiple fractions to treat. The dose range for the study is 20Gy/1 fraction to 24Gy/3 fractions. Each fraction is given on a separate day.
All participants will be followed up at 3 monthly intervals for 12 months after completing their trial treatment (i.e. from the day of their last SRS treatment or 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, bone scan and MRI brain).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Local Therapy | Other | Other: Local TherapyThe local therapy offered will be determined by the participant's doctor in consultation with the site multidisciplinary team and will be dependent on the size and location of the brain metastases. Neurosurgery: The surgery may be performed up to 6 weeks before participant being registered on the trial or up to 4 weeks after registration. Sometimes stereotactic radiosurgery is required to be delivered to the cavity left after the metastasis has been removed (Cavity Boost). Stereotactic Radiosurgery: Treatment is to commence within 4 weeks of study registration. The size, number and location of the brain metastasis will determine the dose and fractionation schedule of radiotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Local TherapyNeurosurgery: The decision whether or not to recommend neurosurgery will be made independently of this research study. The complexity and length of the surgery depends on the size and location of the tumour(s). Stereotactic Radiosurgery: If the participant will be receiving stereotactic radiosurgery (either alone or in combination with neurosurgery), the Radiation Oncologist will organise for the participant to have a Radiotherapy planning. Single metastasis, smaller than or equal to 2cm, may require 1 fraction. Alternately, multiple metastasis, metastasis in the brain stem, or those bigger than 2cm will required multiple fractions to treat. The dose range for the study is 20Gy/1 fraction to 24Gy/3 fractions. | Other | Local Therapy |
Primary outcome
to assess the percentage of patients treated with whole brain radiotherapy within 12 months after completion of local therapy
Time frame: 12 months after completion of local therapy
7 secondary outcomes
To describe distant brain failure incidence (overall and by number of treated metastases)
Time frame: 12 months after completion of local therapy
To describe local brain failure incidence, at any site of SRS or surgery
Time frame: 12 months after completion of local therapy
To describe extra-cranial failure incidence
Time frame: 12 months after completion of local therapy
To describe the pattern of first failure
Time frame: 12 months after completion of local therapy
To describe overall survival and cause of death (neurologic vs. non-neurologic)
Time frame: 12 months after completion of local therapy
To describe adverse events and need for corticosteroids
Time frame: Baseline and at 7-14 days, 3 months, 6 months, 9 months, and 12 months after completion of local therapy
To describe neurocognitive function using the mini-mental state examination (MMSE)
Time frame: Baseline, and at 3, 6, 9, and 12 months after completion of local therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claire Phillips, Dr principal investigator
Peter MacCallum Cancer Centre, Australia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Local Therapy in people with Breast Neoplasms, run by Trans Tasman Radiation Oncology Group at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to assess the percentage of patients treated with whole brain radiotherapy within 12 months after completion of local therapy (time frame: 12 months after completion of local therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2022.