Caelyx was not available anymore

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.

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