Phase 3
Completed N=442
A Study Of Sunitinib In Combination With Capecitabine Compared With Capecitabine In Patients With Breast Cancer
Source: ClinicalTrials.gov NCT00435409 ↗Enrolled (actual)
442
Serious AEs
33.3%
Results posted
Jan 2011
Primary outcomePrimary: Progression Free Survival (PFS) — 5.5; 5.9; 5.4; 5.5 months — p=0.9409
Summary
The treatment received with sunitinib plus capecitabine could delay tumor growth longer than with treatment with capecitabine alone.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) |
5.5; 5.9; 5.4; 5.5 | 0.9409 |
| SECONDARY Percentage of Participants With Objective Response (OR) |
18.6; 16.3; 25.3; 20.4 | 0.3143 |
| SECONDARY Duration of Response (DR) |
9.0; 8.8; 5.7; 7.6 | — |
| SECONDARY Overall Survival (OS) |
16.5; 17.2 | 0.6275 |
| SECONDARY Percent Chance of Participant Survival |
0.635; 0.654; 0.368; 0.373; 0.150; 0.174 | — |
| SECONDARY Change From Baseline in European Organization for Research and Treatment of Cancer's Quality of Life Questionnaire (EORTC QLQ-C30) |
— | — |
| SECONDARY Change From Baseline in European Organization for Research and Treatment of Cancer's Quality of Life Questionnaire Breast Cancer Module (EORTC QLQ-BR23) |
— | — |
| SECONDARY Change From Baseline in EuroQol Group's EuroQol 5-Dimensional Self-Report Questionnaire (EQ-5D) |
— | — |
Eligibility Criteria
Inclusion Criteria
- Locally advanced or metastatic disease that can be measured. Patients with bone-only disease are also allowed to enter the study.
- Previous treatment with an anthracycline and a taxane in any setting
- Progression on first or second line regimen or adjuvant regimen if disease free interval less than 12 months
Exclusion Criteria
- History of inflammatory carcinoma if there is no other measurable disease
- More than 2 chemotherapy agents in the advanced disease setting
- Brain metastases
Data sourced from ClinicalTrials.gov (NCT00435409). 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.