Clinical trial · Interventional
A Study of Xeloda (Capecitabine) in Breast Cancer Patients With Central Nervous System (CNS) Progression
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| capecitabine [Xeloda] | Drug | Capecitabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Drug: capecitabine [Xeloda]
Primary outcomes (1)
- measure
- Progression-free survival
- timeFrame
- 4 months
Secondary outcomes (7)
- measure
- Objective Central Nervous System (CNS) response
- timeFrame
- From first administration of study treatment until documented CNS recurrence or progression
- measure
- Duration of CNS response
- timeFrame
- 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
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available