Clinical trial · Interventional
A Study Of SU011248 Plus Paclitaxel Versus Bevacizumab Plus Paclitaxel In Patients With Advanced Breast Cancer
A Phase 3 Study Of SU011248 In Combination With Paclitaxel Versus Bevacizumab With Paclitaxel In The First-Line Advanced Disease Setting In Patients Having Breast Cancer
NCT00373256CI-TRIAL-00007987completedPhase 3Results 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)
To compare treatment with SU011248 plus paclitaxel versus bevacizumab plus paclitaxel to determine which treatment works better against breast cancer
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 Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bevacizumab | Drug | Bevacizumab | ALIAS |
| paclitaxel | Drug | Paclitaxel | ALIAS |
| Sunitinib | Drug | Sunitinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A
- interventionNames
- Drug: Sunitinib
- Drug: paclitaxel
- type
- ACTIVE_COMPARATOR
- label
- B
- interventionNames
- Drug: bevacizumab
- Drug: paclitaxel
Primary outcomes (1)
- measure
- Progression-Free Survival (PFS)
- timeFrame
- From date of randomization through Day 1 and every 8 weeks thereafter up to 18 months or death
- description
- Time from date of randomization to the date of the first documentation of objective tumor progression or death due to any cause, whichever occurred first. PFS = (first event date minus randomization date +1) divided by 30.4
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of advanced breast cancer. * Measurable disease as per RECIST (Response Evaluation Criterion) in Solid Tumors or bone-only disease. * ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1. Exclusion Criteria: * No prior treatment with cytotoxics in the advanced disease setting. * HER2/neu positive disease unless trastuzumab was previously received or is contraindicated. * Treatment with a taxane in the adjuvant setting unless disease free interval \>12 months after end of treatment.
References
Publications (0)
Data not yet available
No reference posted for this study.