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

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 Overview

• Status: Terminated
• Conditions: Metastatic Breast Cancer
• Intervention / Treatment: Drug: doxorubicinhydrochloride, Lapatinib

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 2

Contacts and Locations

Study Locations

• Austria
  • Salzburg, Austria, 5020
    • Uniklinik Salzburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Caelyx/Lapatinib	Drug: doxorubicinhydrochloride, Lapatinib; Lapatinib 1250mg/d p.o. Caelyx 40 mg/m² i.v. q4w for a maximum of 6 cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
Quality of Life
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)

Collaborators and Investigators

• Sponsor: Arbeitsgemeinschaft medikamentoese Tumortherapie
• Collaborators: GlaxoSmithKline
• Investigators: Principal Investigator: Alois Lang, Dr, LKH Feldkirch; Principal Investigator: Rainhard Ziebermayr, Dr., KH Elisabethinen Linz; Principal Investigator: Richard Greil, Prof., Uniklinik Salzburg; Principal Investigator: Hellmut Samonigg, Prof., Univ. Klinikum Graz; Principal Investigator: Michael Fridrik, Doz., AKH Linz

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: May 14, 2009
• First Submitted That Met QC Criteria: May 15, 2009
• First Posted (Estimate): May 18, 2009

Study Record Updates

• Last Update Posted (Estimate): December 24, 2013
• Last Update Submitted That Met QC Criteria: December 23, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: Lapatinib; metastatic breast cancer; Her2; Caelyx; cardiotoxic
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Lapatinib
• Other Study ID Numbers: AGMT_MBC-5; EudraCT 2008-004530-25