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Local 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.

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616001265460
Acronym
Local HER-O
Enrollment
25
Registered
2016-09-08
Start date
2017-11-20
Completion date
2020-12-22
Last updated
2022-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

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 met requiring treatment. The purpose of the study is to determine; 1. How likely the tumour/s 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. Study Details: For patients who have HER2 positive breast cancer which has spread to the brain (metastasised), the main treatment options for these brain metastasis are Whole Brain Radiotherapy (WBRT), Stereotactic Radiosurgery (SRS) and Neurosurgery (NS) Participants will be given either SRS or surgery or a combination of both depending on the particular features of each tumour. All participants will be followed up at regular 3 monthly intervals for 12 months after completing thier trial treatment (i.e. from the day of their last SRS treatment or of 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, a bone scan and MRI brain).

Interventions

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). Sometimes, if the metastases are small and are not causing any symptoms, they do not require any immediate treatment and will be observed. The purpose of the study is to determine 1) How likely the tumour/s are contr

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). Sometimes, if the metastases are small and are not causing any symptoms, they do not require any immediate treatment and will be observed. The purpose of the study is to determine 1) How likely the tumour/s are controlled after treatment with local therapies Neurosurgery (NS) and/or Stereotactic Radiosurgery (SRS) and 2) How likely is it that other tumours develop at new sites in the brain when no Whole Brain Radiotherapy (WBRT) is given. The local treatment offered will be determined by the patients 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.

Sponsors

Trans Tasman Radiation Oncology Research Group (TROG)
Lead SponsorOther Collaborative groups

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

- 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

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 40mm in size and unable to be resected - Leptomeningeal disease - Pregnant or breastfeeding

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 8, 2026