A Study of Xeloda (Capecitabine) in Breast Cancer Patients With Central Nervous System (CNS) Progression

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: capecitabine [Xeloda]


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: capecitabine [Xeloda]<br>* 1000mg/m2 po bid on days 1-14 of each 3 week cycle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Central Nervous System (CNS) response |  | From first administration of study treatment until documented CNS recurrence or progression | 
| 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 | 
| Clinical benefit \n |  | From first administration of study treatment to study end (12 Months) | 
| 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 |