NCT00916877

Prophylactic Cranial Irradiation in Patients With HER-2-Positive Metastatic Breast Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Alberta Health services · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

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 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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
RADIATION	Prophylactic Cranial Irradiation	Prophylactic Cranial Irradiation

Timeline

• Start date: 2009-11-01
• Primary completion: 2011-03-01
• Completion: 2011-03-01
• First posted: 2009-06-10
• Last updated: 2011-08-08

Locations

1 site across 1 country: Canada