Clinical trial · Interventional
A Study Of Sunitinib In Combination With Capecitabine Compared With Capecitabine In Patients With Breast Cancer
A Randomized, Phase 3 Study Of Sunitinib In Combination With Capecitabine Compared With Capecitabine In Patients With Previously Treated Breast Cancer
NCT00435409CI-TRIAL-00007268completedPhase 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)
The treatment received with sunitinib plus capecitabine could delay tumor growth longer than with treatment with capecitabine alone.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Sunitinib + Capecitabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A
- interventionNames
- Drug: Sunitinib + Capecitabine
- type
- ACTIVE_COMPARATOR
- label
- B
- interventionNames
- Drug: Capecitabine
Primary outcomes (1)
- measure
- Progression Free Survival (PFS)
- timeFrame
- Baseline until disease progression (up to 3 years from first dose)
- description
- Defined as the time from the date of randomization to the date of the first documentation of objective tumor progression or death due to any cause, whichever occurs first. If tumor progression data include more than 1 date, the first date will be used. PFS (in months) will be calculated as (first event date minus randomization date plus 1) divided by 30.4.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDCrown JP, Dieras V, Staroslawska E, Yardley DA, Bachelot T, Davidson N, Wildiers H, Fasching PA, Capitain O, Ramos M, Greil R, Cognetti F, Fountzilas G, Blasinska-Morawiec M, Liedtke C, Kreienberg R, Miller WH Jr, Tassell V, Huang X, Paolini J, Kern KA, Romieu G. Phase III trial of sunitinib in combination with capecitabine versus capecitabine monotherapy for the treatment of patients with pretreated metastatic breast cancer. J Clin Oncol. 2013 Aug 10;31(23):2870-8. doi: 10.1200/JCO.2012.43.3391. Epub 2013 Jul 15. PMID 23857972