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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-007350-35 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| capecitabine [Xeloda] | Drug | 1000mg/m2 po bid on days 1-14 of each 3 week cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | 4 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Angers | 49055 | France | ||||
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
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| 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 |
| Arras |
| 62000 |
| France |
| Béziers | 34500 | France |
| Bobigny | 93009 | France |
| Caen | 14076 | France |
| Lille | 59020 | France |
| Lyon | 69373 | France |
| Narbonne | 11780 | France |
| Nice | 06000 | France |
| Paris | 75475 | France |
| Paris | 75651 | France |
| Salouël | 80480 | France |
| D017437 |
| Skin and Connective Tissue Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |