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

Alberta Health services

Status and phase

Completed

Phase 1

Conditions

Breast Cancer

Treatments

Radiation: Prophylactic Cranial Irradiation

Study type

Interventional

Funder types

Other

Identifiers

NCT00916877

Inhouse

Details and patient eligibility

About

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.

Full 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.

Enrollment

110 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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