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

Metastatic Breast Cancer Clinical Trial

Official title:

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

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

• Breast Neoplasms
• Metastatic Breast Cancer

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