Clinical trial · Interventional
A Study of Local Therapy for the Treatment of Brain Metastases From 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
NCT02898727CI-TRIAL-00062302Local HER-OcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Local Therapy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Local Therapy
- description
- 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.
- interventionNames
- Other: Local Therapy
Primary outcomes (1)
- measure
- to assess the percentage of patients treated with whole brain radiotherapy within 12 months after completion of local therapy
- timeFrame
- 12 months after completion of local therapy
Secondary outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.