At a glance
ClinicalIndex Comparison Record- ✓Unresectable, locally recurrent, or metastatic breast cancer
- ✓HER2 positive disease (3+ by IHC or FISH-positive)
- ✓Candidate for treatment with trastuzumab
- ✓Prior trastuzumab and/or lapatinib in neoadjuvant, adjuvant, or metastatic setting is permitted
- ✕More than 1 regimen of cytotoxic therapy in the advanced disease setting
- ✕Prior severe hypersensitivity reaction to trastuzumab
- ✕Prior treatment on a SU11248 clinical trial
- ✕Uncontrolled brain metastases
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2 Efficacy And Safety Study Of SU011248 In Combination With Trastuzumab As Treatment For Metastatic Disease In Patients With Breast Cancer
In Brief
A Phase 2 clinical trial evaluating SU011248/Trastuzumab for Breast Neoplasms. Completed, enrolled 60 participants across 27 sites in 5 countries.
Detailed 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.
Study Details
Timeline
Interventions
SU011248 will be administered orally, starting dose of 37.5 mg daily on a continuous regimen. Trastuzumab will be administered weekly (loading dose 4 mg/kg followed by weekly 2mg/kg) or every 3 weeks (loading dose 8 mg/kg followed by 6mg/kg q3w). Study treatment should continue until progression, withdrawal for other reasons, or for up to 18 months following which patients requiring continued access will be offered SU011248 on a separate protocol.