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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00916877
• Other study ID #: Inhouse
• Status: Completed
• Phase: Phase 1
• First received: June 8, 2009
• Last updated: August 4, 2011
• Start date: November 2009
• Est. completion date: March 2011

Study information

• Verified date: August 2011
• Source: AHS Cancer Control Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Radiation:
• Prophylactic Cranial Irradiation
Prophylactic Cranial Irradiation

Locations

Country	Name	City	State
Canada	Cross Cancer Institute	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
Alberta Health Services

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	To assess the impact of PCI on measures of survival, specifically brain metastases-free survival, overall progression free survival and overall survival		approximately 4 years from study start	No