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

Phase 1
18 Years
Not Enrolling
Breast Cancer

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Trial Information

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

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.

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

- 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

Type of Study:


Study Design:

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

Outcome Measure:

To evaluate the safety of PCI, specifically with respect to neurocognitive function in patients with HER-2-positive metastatic breast cancer.

Outcome Time Frame:

approximately 2 to 3 years from study start

Safety Issue:



Canada: Health Canada

Study ID:




Start Date:

November 2009

Completion Date:

March 2011

Related Keywords:

  • Breast Cancer
  • Prophylactic Cranial Irradiation
  • Her-2-positive met breast cancer
  • Breast Neoplasms