Metastatic Breast Cancer
Conditions
Keywords
metastatic breast cancer, Her2, Lapatinib, Caelyx, cardiotoxic
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 treatment of metastatic breast cancer following failure of prior trastuzumab.
Interventions
DRUGdoxorubicinhydrochloride, Lapatinib
Lapatinib 1250mg/d p.o. Caelyx 40 mg/m² i.v. q4w for a maximum of 6 cycles
Sponsors
GlaxoSmithKline
Arbeitsgemeinschaft medikamentoese Tumortherapie
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 | — |
Countries
Austria
Outcome results
None listed