Clinical trial · Observational
An Observational Study of Xeloda (Capecitabine) in Participants With Metastatic or Advanced Breast Cancer
Study on Xeloda® to Document Its Use in Routine Practice in Patients With Metastatic or Advanced Breast Cancer
NCT01725386CI-TRIAL-00024057XEPADcompletedResults postedClinicalTrials.gov clinicaltrialsProvenance
- 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 observational study will evaluate the routine clinical use and the safety and efficacy of capecitabine (Xeloda®) in participants with metastatic or advanced breast cancer. Eligible participants will be followed for up to 24 months.
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 | Drug | Capecitabine | ALIAS |
Design
Arms and outcomes
Arms (2)
- label
- Monotherapy
- description
- Capecitabine as monotherapy according to prescribing information and normal clinical practice.
- interventionNames
- Drug: Capecitabine
- label
- Combination Therapy
- description
- Capecitabine as part of combination therapy according to prescribing information and normal clinical practice.
- interventionNames
- Drug: Capecitabine
Primary outcomes (2)
- measure
- Percent of Participants With Capecitabine as a First Line, Second Line, or Third Line Therapy
- timeFrame
- Up to approximately 4 years
- description
- To document use of Capecitabine regimen in the management of participants with metastatic breast cancer, the choice of Capecitabine monotherapy versus combination therapy was summarized according to whether the selection was for the participant's first, second, or third line of treatment.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult female participants, \>/= 18 years of age * Cytologic/histopathologic confirmed diagnosis of metastatic breast cancer * Prescribed capecitabine as in routine clinical practice * Informed consent signed Exclusion Criteria: * Participation in any other clinical trial * History of severe and unexpected reactions to fluoropyrimidine therapy * Hypersensitivity to capecitabine or to any of the excipients of fluorouracil * Known dihydropyrimidine dehydrogenase (DPD) deficiency * Pregnant or lactating women * Severe leucopenia, neutropenia, or thrombocytopenia * Severe hepatic impairment * Severe renal impairment (creatinine clearance below 30 ml/min) * Treatment with sorivudine or its chemically related analogues, such as brivudine * Refusal to give consent
References
Publications (0)
Data not yet available
No reference posted for this study.