Prophylactic Cranial Irradiation in Patients With HER-2-Positive Metastatic Breast Cancer
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Prophylactic Cranial Irradiation in Patients With HER-2-Positive Metastatic Breast Cancer|
- To evaluate the safety of PCI, specifically with respect to neurocognitive function in patients with HER-2-positive metastatic breast cancer. [ Time Frame: approximately 2 to 3 years from study start ] [ Designated as safety issue: Yes ]
- To assess the impact of PCI on measures of survival, specifically brain metastases-free survival, overall progression free survival and overall survival [ Time Frame: approximately 4 years from study start ] [ Designated as safety issue: No ]
|Study Start Date:||November 2009|
|Study Completion Date:||March 2011|
|Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
Radiation: Prophylactic Cranial Irradiation
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.