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

This study has been terminated.

(Caelyx was not available anymore)

Sponsor:

Collaborator:

GlaxoSmithKline

Information provided by (Responsible Party):

Arbeitsgemeinschaft medikamentoese Tumortherapie

ClinicalTrials.gov Identifier:

NCT00903656

First received: May 14, 2009

Last updated: December 23, 2013

Last verified: December 2013

History of Changes

Purpose

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.

Condition	Intervention	Phase
Metastatic Breast Cancer	Drug: doxorubicinhydrochloride, Lapatinib	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Lapatinib Plus Caelyx in Patients With Advanced Metastatic Breast Cancer Following Failure of Trastuzumab Therapy - a Phase II Study

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer

Drug Information available for: Doxorubicin Doxorubicin hydrochloride Trastuzumab Lapatinib Lapatinib Ditosylate

U.S. FDA Resources

Further study details as provided by Arbeitsgemeinschaft medikamentoese Tumortherapie:

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


Enrollment:	24
Study Start Date:	May 2009
Study Completion Date:	May 2012
Primary Completion Date:	May 2012 (Final data collection date for primary outcome measure)

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

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00903656

Locations


Austria
Uniklinik Salzburg
Salzburg, Austria, 5020

Sponsors and Collaborators

Arbeitsgemeinschaft medikamentoese Tumortherapie

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

More Information


Responsible Party:	Arbeitsgemeinschaft medikamentoese Tumortherapie
ClinicalTrials.gov Identifier:	NCT00903656 History of Changes
Other Study ID Numbers:	AGMT_MBC-5 EudraCT 2008-004530-25
Study First Received:	May 14, 2009
Last Updated:	December 23, 2013

Keywords provided by Arbeitsgemeinschaft medikamentoese Tumortherapie:


metastatic breast cancer Her2 Lapatinib Caelyx cardiotoxic

Additional relevant MeSH terms:


Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Liposomal doxorubicin Lapatinib Trastuzumab	Doxorubicin Antineoplastic Agents Antibiotics, Antineoplastic Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on June 23, 2017

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