N/A
Completed N=46
XEBRA Study: An Observational Study of Xeloda (Capecitabine) in Combination With Docetaxel in First Line in Participants With HER2-Negative Metastatic Breast Cancer
Source: ClinicalTrials.gov NCT01777945 ↗Enrolled (actual)
46
Serious AEs
17.4%
Results posted
Aug 2016
Primary outcomePrimary: Progression-free Survival (PFS) — 9.89 months
Summary
This multicenter observational study will evaluate the efficacy and safety of Xeloda (capecitabine) in combination with docetaxel in first-line therapy in participants with HER2-negative metastatic breast cancer. Participants will be followed for approximately 6 months of treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival (PFS) |
9.89 | — |
| SECONDARY Time to Treatment Failure |
4.64 | — |
| SECONDARY Overall Response Rate |
28.9 | — |
| SECONDARY Clinical Benefit Rate |
73.3 | — |
| SECONDARY Duration of Treatment With Xeloda |
6.24 | — |
| SECONDARY Percentage of Capecitabine Dose Modifications |
44.4 | — |
| SECONDARY Number of Participants With Adverse Events |
33 | — |
Eligibility Criteria
Inclusion Criteria
- Adult participants, >/= 18 years of age
- HER2-negative metastatic breast cancer
- Participants initiated on first-line therapy with Xeloda and docetaxel in accordance with the Summary of Product Characteristics; participants who started treatment with Xeloda and docetaxel no more than 3 months before enrollment in this study are also eligible
Exclusion Criteria
- Contraindications to Xeloda treatment according to the Summary of Product Characteristics
Data sourced from ClinicalTrials.gov (NCT01777945). 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.