Phase 3
Completed N=593
Study Of Sunitinib In Combination With Docetaxel Vs Docetaxel In Patients With Advanced Breast Cancer
Source: ClinicalTrials.gov NCT00393939 ↗Enrolled (actual)
593
Serious AEs
32.5%
Results posted
Feb 2011
Primary outcomePrimary: Progression-Free Survival (PFS) — 8.6; 8.3; 8.2; 6.9 months — p=0.2651
Summary
This is a phase 3 randomized trial evaluating the anti-tumor activity and safety of sunitinib combined with docetaxel versus docetaxel, administered as first-line treatment, in patients with unresectable locally recurrent or metastatic breast cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-Free Survival (PFS) |
8.6; 8.3; 8.2; 6.9 | 0.2651 |
| SECONDARY Percentage of Participants With Objective Response |
51.0; 39.1; 52.7; 43.8 | 0.0018 sig |
| SECONDARY Duration of Response (DR) |
7.5; 7.2; 6.9; 5.8 | — |
| SECONDARY Overall Survival (OS) |
26.0; 28.9 | 0.8933 |
| SECONDARY Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionaire-C30 (EORTC- QLQ-C30) Score |
— | — |
| SECONDARY Change From Baseline in EORTC-QLQ Breast Cancer Module (EORTC-QLQ-BR23) Score |
— | — |
| SECONDARY Change From Baseline European Quality of Life 5-dimensional Self-Report Questionnaire (EQ-5D) Score |
— | — |
Eligibility Criteria
Inclusion Criteria
- Breast cancer with evidence of unresectable locally recurrent, or metastatic disease
- Her-2 negative tumors
Exclusion Criteria
- Patients for whom docetaxel is contraindicated
- Clinical presentation of inflammatory carcinoma with no other measurable disease
Data sourced from ClinicalTrials.gov (NCT00393939). 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.