N/A
Completed N=251
An Observational Study of Xeloda (Capecitabine) in Participants With Metastatic or Advanced Breast Cancer
Source: ClinicalTrials.gov NCT01725386 ↗Enrolled (actual)
251
Serious AEs
50.6%
Results posted
Aug 2016
Primary outcomePrimary: Percent of Participants With Capecitabine as a First Line, Second Line, or Third Line Therapy — 10.6; 55.6; 71.8; 41.3 percentage of participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Participants With Capecitabine as a First Line, Second Line, or Third Line Therapy |
10.6; 55.6; 71.8; 41.3; 17.6; 3.1 | — |
| PRIMARY Percentage of Participants Receiving Concomitant Medications During the Study |
17.5; 23.8 | — |
| SECONDARY Percentage of Participants With Relevant Medical History Assessed at Baseline |
0.5; 1.6; 9.6; 12.7; 18.1; 28.6 | — |
| SECONDARY Percentage of Participants by Histopathology Grade Diagnosis Assessed at Baseline |
42.6; 42.9; 9.0; 11.1; 48.4; 46.0 | — |
| SECONDARY Mean Survival Time |
15.493; 15.417 | 0.895 |
| SECONDARY Percentage of Participants With Adverse Events |
45.2; 66.7 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01725386). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.