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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00916877
Recruitment Status : Completed
First Posted : June 10, 2009
Last Update Posted : August 8, 2011
Information provided by:
AHS Cancer Control Alberta

Brief 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Radiation: Prophylactic Cranial Irradiation Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prophylactic Cranial Irradiation in Patients With HER-2-Positive Metastatic Breast Cancer
Study Start Date : November 2009
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Intervention Details:
    Radiation: Prophylactic Cranial Irradiation
    Prophylactic Cranial Irradiation

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00916877

Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Sponsors and Collaborators
Alberta Health Services

Responsible Party: Drs Abdulkarim, Gabos and Mackey, Cross Cancer Institute Identifier: NCT00916877     History of Changes
Other Study ID Numbers: Inhouse
First Posted: June 10, 2009    Key Record Dates
Last Update Posted: August 8, 2011
Last Verified: August 2011

Keywords provided by AHS Cancer Control Alberta:
Prophylactic Cranial Irradiation
Her-2-positive met breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases