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

• Status: Terminated
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

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 treatment of metastatic breast cancer following failure of prior trastuzumab.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Arbeitsgemeinschaft medikamentoese Tumortherapie
• Collaborator: GlaxoSmithKline
• Treatments: Doxorubicin; Lapatinib; Liposomal doxorubicin; Trastuzumab

Criteria

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