Trial | NCT00903656  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    24
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.
Study Started
May 31
2009
Primary Completion
May 31
2012
Study Completion
May 31
2012
Last Update
Dec 24
2013
Estimate

Drug doxorubicinhydrochloride, Lapatinib

Lapatinib 1250mg/d p.o. Caelyx 40 mg/m² i.v. q4w for a maximum of 6 cycles

Caelyx/Lapatinib Experimental

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
No Results Posted