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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02898727




Registration number
NCT02898727
Ethics application status
Date submitted
7/09/2016
Date registered
13/09/2016
Date last updated
22/11/2022

Titles & IDs
Public title
A Study of Local Therapy for the Treatment of Brain Metastases From HER2 Positive Breast Cancer
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
Secondary ID [1] 0 0
TROG 16.02
Universal Trial Number (UTN)
Trial acronym
Local HER-O
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Brain
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Local Therapy

Other: Local Therapy - 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.


Other interventions: Local Therapy
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.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
to assess the percentage of patients treated with whole brain radiotherapy within 12 months after completion of local therapy
Timepoint [1] 0 0
12 months after completion of local therapy
Secondary outcome [1] 0 0
To describe distant brain failure incidence (overall and by number of treated metastases)
Timepoint [1] 0 0
12 months after completion of local therapy
Secondary outcome [2] 0 0
To describe local brain failure incidence, at any site of SRS or surgery
Timepoint [2] 0 0
12 months after completion of local therapy
Secondary outcome [3] 0 0
To describe extra-cranial failure incidence
Timepoint [3] 0 0
12 months after completion of local therapy
Secondary outcome [4] 0 0
To describe the pattern of first failure
Timepoint [4] 0 0
12 months after completion of local therapy
Secondary outcome [5] 0 0
To describe overall survival and cause of death (neurologic vs. non-neurologic)
Timepoint [5] 0 0
12 months after completion of local therapy
Secondary outcome [6] 0 0
To describe adverse events and need for corticosteroids
Timepoint [6] 0 0
Baseline and at 7-14 days, 3 months, 6 months, 9 months, and 12 months after completion of local therapy
Secondary outcome [7] 0 0
To describe neurocognitive function using the mini-mental state examination (MMSE)
Timepoint [7] 0 0
Baseline, and at 3, 6, 9, and 12 months after completion of local therapy

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/11/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/12/2021
Sample size
Target
Accrual to date
Final
25
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
3000 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Trans Tasman Radiation Oncology Group
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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).
Trial website
https://clinicaltrials.gov/study/NCT02898727
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Claire Phillips, Dr
Address 0 0
Peter MacCallum Cancer Centre, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02898727