Status:
TERMINATED
A Study of Whole Brain Radiation Therapy and Capecitabine in Breast Cancer Participants With Newly Diagnosed Brain Metastasis
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
This open-label, randomized, parallel arm study will evaluate the effect of capecitabine administered concurrently with WBRT and as maintenance therapy in participants with breast cancer and newly dia...
Eligibility Criteria
Inclusion
- Women with histologically confirmed breast cancer with known human epidermal receptor-2 (HER2) and hormone status
- Newly diagnosed CNS metastasis with at least one brain lesion measuring greater than or equal to (\>/=) 1 centimeter (cm) or two lesions measuring \>/= 0.5 to less than (\<) 1 cm in longest dimension
- Participant not eligible for or refusing surgery or stereotactic radiosurgery
- Eastern cooperative oncology group (EOCG) performance status 0 to 2
Exclusion
- Prior treatment of brain metastases
- Leptomeningeal disease
- Known contra-indication to radiotherapy or magnetic resonance imaging (MRI) or capecitabine
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00977379
Start Date
August 1 2009
End Date
February 1 2011
Last Update
November 15 2016
Active Locations (16)
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1
Arras, France, 62000
2
Beuvry, France, 62660
3
Béziers, France, 34500
4
Bobigny, France, 93009