Prophylactic Cranial Irradiation in Patients With HER-2-Positive Metastatic Breast Cancer
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 potentially harmful chemicals such as chemotherapy agents and antibodies such
as trastuzumab from reaching the brain. Decreasing the incidence of brain metastasis with
acceptable effects on neurocognitive function would be a significant improvement in the care
of patients with MBC.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate the safety of PCI, specifically with respect to neurocognitive function in patients with HER-2-positive metastatic breast cancer.
approximately 2 to 3 years from study start
Yes
Canada: Health Canada
Inhouse
NCT00916877
November 2009
March 2011
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