Phase 2
Completed N=60
Open Label Study Of SU011248 In Combination With Trastuzumab For Patients With Metastatic Breast Cancer
Source: ClinicalTrials.gov NCT00243503 ↗Enrolled (actual)
60
Serious AEs
41.7%
Results posted
May 2010
Primary outcomePrimary: Percentage of Participants With Overall Confirmed Objective Disease Response — 36.8 percentage of participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Overall Confirmed Objective Disease Response |
36.8 | — |
| SECONDARY Duration of Response (DR) |
25.6 | — |
| SECONDARY Percentage of Participants With Clinical Benefit |
56.1 | — |
| SECONDARY Progression Free Survival (PFS) |
28.0 | — |
| SECONDARY Time to Progression (TTP) |
26.0 | — |
| SECONDARY Overall Survival (OS) |
NA | — |
| SECONDARY Probability of Survival at One Year |
91.2 | — |
| SECONDARY EORTC QLQ-C30 |
56.0; 75.2; 60.1; 84.5; 66.1; 66.7 | — |
| SECONDARY EORTC QLQ (BR23) |
76.4; 14.6; 33.3; 45.7; 21.7; 19.4 | — |
| SECONDARY Dose-corrected Trough Plasma Concentrations (Ctrough) of Sunitinib |
53.5; 55.0 | — |
| SECONDARY Dose-corrected Ctrough of SU-012662 (Sunitinib's Metabolite) |
26.7; 24.7 | — |
| SECONDARY Dose-corrected Ctrough of Total Drug (Sunitinib + SU-012662) |
80.2; 79.7 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00243503). 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.