Lapatinib Plus Caelyx in Patients With Advanced Metastatic Breast Cancer Following Failure of Trastuzumab Therapy

Study Overview
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Brief Summary
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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 treatment of metastatic breast cancer following failure of prior trastuzumab.

Official Title
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Lapatinib Plus Caelyx in Patients With Advanced Metastatic Breast Cancer Following Failure of Trastuzumab Therapy - a Phase II Study

Conditions
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Metastatic Breast Cancer

Intervention / Treatment
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* Drug: doxorubicinhydrochloride, Lapatinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Caelyx/Lapatinib<br> | Drug: doxorubicinhydrochloride, Lapatinib<br>* Lapatinib 1250mg/d p.o. Caelyx 40 mg/m² i.v. q4w for a maximum of 6 cycles<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of a Lapatinib plus Caelyx combination regimen in the treatment of advanced metastatic breast cancer, in terms of overall response rates (complete or partial response)determined by RECIST |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety profile |  |  | 
| Occurrence of clinically apparent brain metastases |  |  | 
| Overall survival, progression free survival, clinical benefit (CR, PR or stable disease for at least 24 weeks) |  |  | 
| Quality of Life |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Her2, metastatic breast cancer, Lapatinib, Caelyx, cardiotoxic