Status:
TERMINATED
Lapatinib Plus Caelyx in Patients With Advanced Metastatic Breast Cancer Following Failure of Trastuzumab Therapy
Lead Sponsor:
Arbeitsgemeinschaft medikamentoese Tumortherapie
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Metastatic Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The aim of this study is to evaluate the potential of a Lapatinib plus Caelyx combination therapy as an effective and safe therapeutic regimen with a favourable cardiotoxicity profile, in the treatmen...
Eligibility Criteria
Inclusion
- Female patients, age ≥ 18 years
- 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
- Pregnant or lactating women
- 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
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00903656
Start Date
May 1 2009
End Date
May 1 2012
Last Update
December 24 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Uniklinik Salzburg
Salzburg, Salzburg, Austria, 5020