NCT02898727

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 Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 7, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 13, 2016

Completed
1.2 years until next milestone

Study Start

First participant enrolled

November 20, 2017

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 22, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

November 22, 2022

Status Verified

November 1, 2022

Enrollment Period

3.7 years

First QC Date

September 7, 2016

Last Update Submit

November 17, 2022

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (1)

  • to assess the percentage of patients treated with whole brain radiotherapy within 12 months after completion of local therapy

    12 months after completion of local therapy

Secondary Outcomes (7)

  • To describe distant brain failure incidence (overall and by number of treated metastases)

    12 months after completion of local therapy

  • To describe local brain failure incidence, at any site of SRS or surgery

    12 months after completion of local therapy

  • To describe extra-cranial failure incidence

    12 months after completion of local therapy

  • To describe the pattern of first failure

    12 months after completion of local therapy

  • To describe overall survival and cause of death (neurologic vs. non-neurologic)

    12 months after completion of local therapy

  • +2 more secondary outcomes

Study Arms (1)

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.

Other: Local Therapy

Interventions

Local TherapyOTHER

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.

Local Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years or older
  • Metastatic HER2 positive breast cancer
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3000, Australia

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Hyperthermia, Induced

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Claire Phillips, Dr

    Peter MacCallum Cancer Centre, Australia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2016

First Posted

September 13, 2016

Study Start

November 20, 2017

Primary Completion

July 22, 2021

Study Completion

December 31, 2021

Last Updated

November 22, 2022

Record last verified: 2022-11

Locations

AU(1)