Clinical trial · Interventional
Prophylactic Cranial Irradiation in Patients With HER-2-Positive Metastatic Breast Cancer
NCT00916877CI-TRIAL-00005337completedPhase 1ClinicalTrials.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)
Though brain metastases are a risk in all patients with breast cancer, those with HER-2 overexpression are at significantly greater risk. One series estimated a 30% incidence of brain metastases in this population, while another study found an incidence of approximately 40%. Traditional systemic therapies do not cross the blood brain barrier to any significant degree or at all, but radiation treatment can be effective in the treatment of intracranial metastases.
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 Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prophylactic Cranial Irradiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To evaluate the safety of PCI, specifically with respect to neurocognitive function in patients with HER-2-positive metastatic breast cancer.
- timeFrame
- approximately 2 to 3 years from study start
Secondary outcomes (1)
- measure
- To assess the impact of PCI on measures of survival, specifically brain metastases-free survival, overall progression free survival and overall survival
- timeFrame
- approximately 4 years from study start
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female with HER2-positive disease * 18 years of age or older * ECOG greater or equal to 2 * Life expectancy greater or equal to 6 months * Able to complete self administered quality of life evaluations and neurocognitive testing * Willing and able to comply with study instructions and commit to all clinic visits for the duration of the study * Women of child-bearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at the baseline visit and must use highly effective birth control during study * Signed informed consent form Exclusion Criteria: * Current malignancy in the brain, as determined by screening MRI/CT done no more then 6 weeks prior to study treatment with PCI * Chemo or radiation planned during the period when patients will receive study treatment with PCI * Prior radiotherapy of the brain * Prior stroke or brain hemorrhage in the 6 months prior to screening * History of neurological/psychiatric disorders, including psychotic disorders or demential, or any other reason, which may affect neurocognitive assessment * Inadequate renal function * Other known previous or concomitant serious illness or medical condition that may interfere with participation in the study
References
Publications (0)
Data not yet available
No reference posted for this study.