Clinical trial · Interventional
Open Label Study Of SU011248 In Combination With Trastuzumab For Patients With Metastatic Breast Cancer
A Phase 2 Efficacy And Safety Study Of SU011248 In Combination With Trastuzumab As Treatment For Metastatic Disease In Patients With Breast Cancer
NCT00243503CI-TRIAL-00005262completedPhase 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)
The current study is to evaluate: Overall response rate for the combination of trastuzumab and SU011248 in metastatic or locally recurrent breast cancer; evaluate safety and tolerability of the combination; measure duration of tumor control and survival; assess patient reported outcomes; assess PK in combination with trastuzumab and compare efficacy and safety.
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 |
|---|---|---|---|
| SU011248/Trastuzumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- A
- interventionNames
- Drug: SU011248/Trastuzumab
Primary outcomes (1)
- measure
- Percentage of Participants With Overall Confirmed Objective Disease Response
- timeFrame
- From start of treatment through 18 months
- description
- Objective disease response =participants with confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). A CR was defined as the disappearance of all target and non-target lesions. A PR was defined as a \> = 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions associated to a non-progressive disease response for the non target lesions.
Secondary outcomes (11)
- measure
- Duration of Response (DR)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * A diagnosis of breast cancer with evidence of 1) unresectable, locally recurrent, or 2) metastatic disease. * HER2 positive disease (3+ by immunohistochemistry \[IHC\] or FISH-positive) * Candidate for treatment with trastuzumab. Prior treatment with trastuzumab and or/ lapatinib in the neoadjuvant, adjuvant or metastatic disease setting is permitted. Treatment with hormone therapy in the adjuvant and/or advanced disease setting is permitted. Exclusion Criteria: * Prior treatment with \>1 regimen of cytotoxic therapy in the advanced disease setting. Adjuvant chemotherapy is permitted * Prior exposure to trastuzumab if the patient had developed severe hypersensitivity reactions. * Prior treatment on a SU11248 clinical trial. * Uncontrolled brain metastases.
References
Publications (1)
- DERIVEDBachelot T, Garcia-Saenz JA, Verma S, Gutierrez M, Pivot X, Kozloff MF, Prady C, Huang X, Khosravan R, Wang Z, Cesari R, Tassell V, Kern KA, Blay JY, Lluch A. Sunitinib in combination with trastuzumab for the treatment of advanced breast cancer: activity and safety results from a phase II study. BMC Cancer. 2014 Mar 7;14:166. doi: 10.1186/1471-2407-14-166. PMID 24606768