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

NCT00916877 | Completed Phase 1

• 1 other identifier: Inhouse
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Prophylactic Cranial Irradiation; Her-2-positive met breast cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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

Interventions

Prophylactic Cranial Irradiation RADIATION

Prophylactic Cranial Irradiation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female with HER2-positive disease
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alberta Health services: lead

Study Sites (1)

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 8, 2009
• First Posted: June 10, 2009
• Study Start: November 1, 2009
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: August 8, 2011

Record last verified: 2011-08

Locations

CA (1)