XERAD: Open-label, Phase II, Randomized, Comparative, Multicentre Trial of Concurrent Whole Brain Radiation Therapy (WBRT) and Capecitabine (Xeloda® ) Followed by Maintenance Capecitabine Compared With Standard WBRT in Breast Cancer Patients With Newly Diagnosed Brain Metastasis
18 Years
N/A
Female
Breast Cancer
Trial Information
XERAD: Open-label, Phase II, Randomized, Comparative, Multicentre Trial of Concurrent Whole Brain Radiation Therapy (WBRT) and Capecitabine (Xeloda® ) Followed by Maintenance Capecitabine Compared With Standard WBRT in Breast Cancer Patients With Newly Diagnosed Brain Metastasis
Inclusion Criteria:
- women >/= 18 years of age
- histologically confirmed breast cancer with known HER2 and hormone status
- newly diagnosed CNS metastasis with at least one measurable (>/=0.5cm) lesion
- patient not eligible or refusing surgery or stereotactic radiosurgery
- EOCG performance status 0-2
Exclusion Criteria:
- prior treatment of brain metastases
- prior disease progression or appearance of brain metastases while on treatment with
capecitabine
- leptomeningeal disease
- known contra-indication to radiotherapy or MRI or capecitabine
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Best objective CNS response (CR+PR) assessed by contrast-enhanced MRI reviewed by centralized independent expert
Outcome Time Frame:
MRI 6 weeks after 1st day of radiotherapy and every 9 weeks thereafter
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
ML21873
NCT ID:
NCT00977379
Start Date:
August 2009
Completion Date:
August 2011
Related Keywords:
- Breast Cancer
- Breast Neoplasms
- Neoplasm Metastasis
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