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Closed (no longer recruiting)Last updated: 12 February 2024

Local HER-O: This phase II trial is using radiosurgery and/or surgery to treat brain metastases that have spread from HER 2+ breast cancerA 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 summary

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).

Conditions

This trial is treating patients with brain metastases from HER 2+ breast cancer.

Cancer

Breast Cancers Breast

Age

People18+

Phase

II

Trial Acronym

Local HER-O

More information

Trial Identifiers

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Trial sponsor

Trans Tasman Radiation Oncology Group (TROG)

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

Eligibility

Inclusion

- 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

- 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

Inclusion

  • Your cancer has spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
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Clinical trials have complex eligibility criteria.

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