Clinical Trials /

A Study of Local Therapy for the Treatment of Brain Metastases From HER2 Positive Breast Cancer

NCT02898727

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).

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

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

  • Breast Neoplasms

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

NameTypeDescriptionInterventions
Local TherapyOtherThe 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:Recruiting
    Lead Sponsor:Trans-Tasman Radiation Oncology Group (TROG)

    Last Updated