Breast Cancer
Conditions
Brief summary
This single arm study will assess the efficacy of Xeloda in the treatment of brain metastases in breast cancer patients with central nervous system (CNS) progression after whole brain radiotherapy. Patients will receive xeloda 1000mg/m2 po bid on days 1-14 of each 3 week cycle. The anticipated time on study treatment is until disease progression, and the target sample size is \<100 individuals.
Interventions
DRUGcapecitabine [Xeloda]
1000mg/m2 po bid on days 1-14 of each 3 week cycle
Sponsors
Hoffmann-La Roche
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival | 4 months |
Secondary
| Measure | Time frame |
|---|---|
| Duration of CNS response | From time of first documented cranial complete response (CR) or partial response (PR) (whichever is recorded first) until the first date CNS recurrence or progression is documented |
| Cranial PFS | From the first administration of study treatment to the time of documented cranial recurrence or progression\n |
| Progression-free survival\n | From the first administration of study treatment to the time of documented recurrence or progression\n |
| Objective Central Nervous System (CNS) response | From first administration of study treatment until documented CNS recurrence or progression |
| Extra-cranial disease response rate\n | From first administration of study treatment to the time of documented extra-cranial recurrence or progression |
| Overall Survival (OS)\n | From first administration of study treatment to the time of death from any cause |
| Clinical benefit \n | From first administration of study treatment to study end (12 Months) |
Countries
France
Outcome results
None listed