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

This study has been completed.
Sponsor:
Information provided by:
AHS Cancer Control Alberta
ClinicalTrials.gov Identifier:
NCT00916877
First received: June 8, 2009
Last updated: August 4, 2011
Last verified: August 2011
  Purpose

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 Intervention Phase
Breast Cancer
Radiation: Prophylactic Cranial Irradiation
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prophylactic Cranial Irradiation in Patients With HER-2-Positive Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by AHS Cancer Control Alberta:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 110
Study Start Date: November 2009
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Radiation: Prophylactic Cranial Irradiation
    Prophylactic Cranial Irradiation
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00916877

Locations
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Sponsors and Collaborators
AHS Cancer Control Alberta
  More Information

No publications provided

Responsible Party: Drs Abdulkarim, Gabos and Mackey, Cross Cancer Institute
ClinicalTrials.gov Identifier: NCT00916877     History of Changes
Other Study ID Numbers: Inhouse
Study First Received: June 8, 2009
Last Updated: August 4, 2011
Health Authority: Canada: Health Canada

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
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 21, 2014