A Single Arm, Open-label Trial Assessing the Effect of Capecitabine (Xeloda® ) on Progression-free Survival Rate at Four Months in Breast Cancer Patients With CNS Progression After Whole Brain Radiotherapy
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Female
Breast Cancer
Female
Breast Cancer
Trial Information
A Single Arm, Open-label Trial Assessing the Effect of Capecitabine (Xeloda® ) on Progression-free Survival Rate at Four Months in Breast Cancer Patients With CNS Progression After Whole Brain Radiotherapy
Inclusion Criteria:
- female patients, >=18 years of age;
- breast cancer;
- CNS progression after radio-surgery + whole brain radiotherapy, or whole brain
radiotherapy alone;
- at least one measurable lesion;
- ECOG performance status 0-2.
Exclusion Criteria:
- prior systemic treatment of brain metastases;
- prior disease progression while on Xeloda treatment;
- previous history of cancer (other than curatively treated basal and squamous cell
cancer of the skin or in situ cancer of the cervix) in previous 5 years;
- clinically significant cardiovascular disease.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression-free survival
Outcome Time Frame:
4 months
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:
ML22203
NCT ID:
NCT01077726
Start Date:
January 2010
Completion Date:
April 2011
Related Keywords:
- Breast Cancer
- Breast Neoplasms
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