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

Primary Purpose

Metastatic Breast Cancer

Status

Terminated

Phase

Phase 2

Locations

Austria

Study Type

Interventional

Intervention

doxorubicinhydrochloride, Lapatinib

About this trial

This is an interventional treatment trial for Metastatic Breast Cancer focused on measuring metastatic breast cancer, Her2, Lapatinib, Caelyx, cardiotoxic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Uniklinik Salzburg

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Caelyx/Lapatinib

Arm Description

Outcomes

Primary Outcome Measures

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 Outcome Measures

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

Full Information

NCT ID

NCT00903656

First Posted

May 14, 2009

Last Updated

December 23, 2013

Sponsor

Arbeitsgemeinschaft medikamentoese Tumortherapie

Collaborators

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00903656

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2013

Overall Recruitment Status

Terminated

Why Stopped

Caelyx was not available anymore

Study Start Date

May 2009 (undefined)

Primary Completion Date

May 2012 (Actual)

Study Completion Date

May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Arbeitsgemeinschaft medikamentoese Tumortherapie

Collaborators

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastatic Breast Cancer

Keywords

metastatic breast cancer, Her2, Lapatinib, Caelyx, cardiotoxic

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Caelyx/Lapatinib

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

doxorubicinhydrochloride, Lapatinib

Intervention Description

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

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

Safety profile

Title

Occurrence of clinically apparent brain metastases

Title

Overall survival, progression free survival, clinical benefit (CR, PR or stable disease for at least 24 weeks)

Title

Quality of Life

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials: