Status:
COMPLETED
Lapatinib and Temozolomide for the Treatment of Progressive Brain Disease in HER-2 Positive Breast Cancer
Lead Sponsor:
Jules Bordet Institute
Collaborating Sponsors:
GlaxoSmithKline
Schering-Plough
Conditions:
Metastatic Breast Cancer
Brain Metastases
Eligibility:
FEMALE
18-70 years
Phase:
PHASE1
Brief Summary
Objectives: Primary - Determine the maximum tolerated dose (MTD) and evaluate the dose limiting toxicities (DLT) of combining lapatinib and temozolomideSecondary - Obtain preliminary information on t...
Detailed Description
Patients selection criteria: * age 18 - 70 years * Women with cytologically or histologically proven metastatic breast cancer with recurrent / progressive brain metastases evaluable by MRI, after sta...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 18 - 70 years
- Women with cytologically or histologically proven metastatic breast cancer with recurrent / progressive brain metastases evaluable by MRI, after standard treatment with surgery (at least 3 weeks prior) or WBRT (at least 3 weeks prior) or stereotactic RT (at least 1 week prior); or otherwise deemed as unsuitable for standard treatment in the first instance
- Known HER-2 positive status (immunohistochemistry (IHC) 3+ Fluorescence In Situ Hybridization (FISH) positive )
- Previous chemotherapy (adjuvant and metastatic regimens) allowed
- Previous treatment with trastuzumab allowed (Trastuzumab to be discontinued prior to study entry)
- At least one measurable lesion in the brain, defined as any lesion \>5mm in longest dimension on T1-weighted, gadolinium-enhanced MRI
- Expected life-expectancy of more than 3 months
- ECOG performance status of 0, 1 or 2
- Adequate bone marrow, renal and hepatic functionsLVEF
- LVEF \>50% measured by echocardiography or MUGA scan
- Concomitant corticosteroids and anti-convulsants for symptomatic brain metastases are allowed
Exclusion
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00614978
Start Date
January 1 2008
End Date
June 1 2011
Last Update
September 19 2012
Active Locations (1)
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1
Jules Bordet Institute
Brussels, Belgium, 1000