Clinical trial · Interventional
Efficacy And Safety Of Sunitinib In Women With Advanced Breast Cancer
A Phase II Study Of Sunitinib Malate Single Agent For The Treatment Of Women With Advanced Breast Cancer
NCT00471276CI-TRIAL-00005279completedPhase 2Results 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)
Patients with advanced breast cancer to receive sunitinib (Sutent) once daily until disease progression.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| sunitinib | Drug | Sunitinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Drug: sunitinib
Primary outcomes (1)
- measure
- Number of Participants With Objective Response
- timeFrame
- Baseline, Week 9, and every 8 weeks up to Month 34
- description
- Number of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as disappearance of all target lesions. PR defined as a greater than or equal to 30 percent (≥30%) decrease in sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
Secondary outcomes (18)
- measure
- Number of Participants With Clinical Benefit
- timeFrame
- Baseline, Week 9, and every 8 weeks up to Month 34
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically proven diagnosis of breast cancer * Metastatic or locally recurrent disease that is, in the opinion of the investigator, not amenable to resection or radiation therapy * Patients with at least one measurable lesion as per RECIST Exclusion Criteria: * Inflammatory breast cancer * Prior treatment with VEGF inhibitors (unless in adjuvant setting at least 12 months ago)
References
Publications (0)
Data not yet available
No reference posted for this study.