Lapatinib Plus Caelyx in Patients With Advanced Metastatic Breast Cancer Following Failure of Trastuzumab Therapy
NCT ID: NCT00903656
Last Updated: 2013-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
24 participants
INTERVENTIONAL
2009-05-31
2012-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Caelyx/Lapatinib
doxorubicinhydrochloride, Lapatinib
Lapatinib 1250mg/d p.o. Caelyx 40 mg/m² i.v. q4w for a maximum of 6 cycles
Interventions
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doxorubicinhydrochloride, Lapatinib
Lapatinib 1250mg/d p.o. Caelyx 40 mg/m² i.v. q4w for a maximum of 6 cycles
Eligibility Criteria
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Inclusion Criteria
* Advanced or metastatic breast cancer, histologically confirmed
* Documented HER2 overexpression (IHC 3+ and/or FISH positive)
* At least one measurable lesion according to RECIST criteria. Patients with bone-only lesions are not eligible for study entry
* Documented disease progression
* Patients may have no more than 1 line of palliative treatment, however prior therapies must include trastuzumab in adjuvant or metastatic setting
* Life expectancy of at least 12 weeks
* Performance status 0-1
* Cardiac ejection fraction \>= 50% as measured by echocardiogram or MUGA scan
* Adequate hematology, liver and renal function
Exclusion Criteria
* Serious medical or psychiatric disorders that would interfere with the patient's safety or informed consent
* Severe cardiac disease (uncontrolled angina, arrhythmia, chronic heart failure (CHF) or cardiac disease requiring a device)
* Ejection fraction below the institutional normal limit
* Maximum cumulative dose of 360 mg/m2 for doxorubicin and 720 mg/m2 for epirubicin
* Active bacterial, viral or fungal infection
* Patients with clinically apparent brain metastases
* Positivity for HIV, Hepatitis B or C
* History of other malignancy; patients who have been disease-free for 5 years
* Concurrent cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy) or concurrent treatment with an investigational drug or participation in another clinical trial
* Known hypersensitivity to the study drugs Lapatinib and Caelyx or their excipients
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Arbeitsgemeinschaft medikamentoese Tumortherapie
OTHER
Responsible Party
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Principal Investigators
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Alois Lang, Dr
Role: PRINCIPAL_INVESTIGATOR
LKH Feldkirch
Rainhard Ziebermayr, Dr.
Role: PRINCIPAL_INVESTIGATOR
KH Elisabethinen Linz
Richard Greil, Prof.
Role: PRINCIPAL_INVESTIGATOR
Uniklinik Salzburg
Hellmut Samonigg, Prof.
Role: PRINCIPAL_INVESTIGATOR
Univ. Klinikum Graz
Michael Fridrik, Doz.
Role: PRINCIPAL_INVESTIGATOR
AKH Linz
Locations
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Uniklinik Salzburg
Salzburg, Salzburg, Austria
Countries
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Other Identifiers
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EudraCT 2008-004530-25
Identifier Type: -
Identifier Source: secondary_id
AGMT_MBC-5
Identifier Type: -
Identifier Source: org_study_id