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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00903656
Other study ID # AGMT_MBC-5
Secondary ID EudraCT 2008-004
Status Terminated
Phase Phase 2
First received May 14, 2009
Last updated December 23, 2013
Start date May 2009
Est. completion date May 2012

Study information

Verified date December 2013
Source Arbeitsgemeinschaft medikamentoese Tumortherapie
Contact n/a
Is FDA regulated No
Health authority Austria: Agency for Health and Food Safety
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 24
Est. completion date May 2012
Est. primary completion date May 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Austria Uniklinik Salzburg Salzburg

Sponsors (2)

Lead Sponsor Collaborator
Arbeitsgemeinschaft medikamentoese Tumortherapie GlaxoSmithKline

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Safety profile Yes
Secondary Occurrence of clinically apparent brain metastases Yes
Secondary Overall survival, progression free survival, clinical benefit (CR, PR or stable disease for at least 24 weeks) Yes
Secondary Quality of Life Yes
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