Status:
COMPLETED
Prophylactic Cranial Irradiation in Patients With HER-2-Positive Metastatic Breast Cancer
Lead Sponsor:
Alberta Health services
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief Summary
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 th...
Detailed Description
The rationale for PCI is that the brain is a sanctuary site where cancer cells can remain inaccessible to chemotheraphy and agents such as trastuzumab due to the blood brain barrier, which prevents po...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2011
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT00916877
Start Date
November 1 2009
End Date
March 1 2011
Last Update
August 8 2011
Active Locations (1)
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1
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2