Description:
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).
Title
- Brief Title: A Study of Local Therapy for the Treatment of Brain Metastases From HER2 Positive Breast Cancer
- 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
Clinical Trial IDs
- ORG STUDY ID:
TROG 16.02
- NCT ID:
NCT02898727
Conditions
Purpose
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:
1. . How likely the tumours 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.
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).
Trial Arms
| Name | Type | Description | Interventions |
|---|
| 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. | |
Eligibility Criteria
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
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| 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 |
| Safety Issue: | |
| Description: | |
Secondary Outcome Measures
| Measure: | To describe distant brain failure incidence (overall and by number of treated metastases) |
| Time Frame: | 12 months after completion of local therapy |
| Safety Issue: | |
| Description: | |
| Measure: | To describe local brain failure incidence, at any site of SRS or surgery |
| Time Frame: | 12 months after completion of local therapy |
| Safety Issue: | |
| Description: | |
| Measure: | To describe extra-cranial failure incidence |
| Time Frame: | 12 months after completion of local therapy |
| Safety Issue: | |
| Description: | |
| Measure: | To describe the pattern of first failure |
| Time Frame: | 12 months after completion of local therapy |
| Safety Issue: | |
| Description: | |
| Measure: | To describe overall survival and cause of death (neurologic vs. non-neurologic) |
| Time Frame: | 12 months after completion of local therapy |
| Safety Issue: | |
| Description: | |
| Measure: | 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 |
| Safety Issue: | |
| Description: | |
| Measure: | 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 |
| Safety Issue: | |
| Description: | |
Details
| Phase: | Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Active, not recruiting |
| Lead Sponsor: | Trans Tasman Radiation Oncology Group |
Last Updated
February 9, 2021
