Advanced metastatic breast cancer following failure of prior trastuzumab-containing regimen
Conditions
Interventions
Trade Name: Tyverb
Product Name: Lapatinib
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: LAPATINIB
CAS Number: 231277-92-2
Concentration unit: mg milligram(s)
Concentration type: equal
Sponsors
Arbeitsgemeinschaft medikamentöse Tumortherapie gemeinnützige GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Advanced or metastatic breast cancer, histologically confirmed •Documented HER2 overexpression (IHC 3+ and/or FISH positive) •Documented disease progression •Patients that are progredient after Trastuzumab therapy (palliative or adjuvant) •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: Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 •Concurrent cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy) or concurrent treatment with an investigational drug or participation in another clinical trial •Radiation of the target lesion within the last 4 weeks before study entry
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: •To determine the safety profile of a Lapatinib/ Caelyx combination regimen in terms of qualitative and quantitative toxicities from first study treatment dose until completion of study treatment due to progression or for any other reason. •To evaluate the incidence of clinically apparent brain metastases. •To evaluate the study population with respect to the following: overall survival (from treatment start until death from any cause), progression free survival (from treatment start until progression or death from any cause), clinical benefit (CR, PR or stable disease for at least 24 weeks). •To evaluate Quality of Life (QoL) status within the study population as captured using the EORTC QLQ-C30 standard questionnaire. ;Primary end point(s): The primary objective of this study is to determine the 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 radiologic evaluation according to Response Evaluation Criteria in Solid Tumors (RECIST)).;Main Objective: to determine the 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 radiologic evaluation according to Response Evaluation Criteria in Solid Tumors (RECIST)) | — |
Countries
Austria
Outcome results
None listed