ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00903656
Recruitment Status : Terminated (Caelyx was not available anymore)
First Posted : May 18, 2009
Last Update Posted : December 24, 2013
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Arbeitsgemeinschaft medikamentoese Tumortherapie

Study Description
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: doxorubicinhydrochloride, Lapatinib Phase 2

Study Design
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : May 2009
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arms and Interventions
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 :
  1. Safety profile
  2. Occurrence of clinically apparent brain metastases
  3. Overall survival, progression free survival, clinical benefit (CR, PR or stable disease for at least 24 weeks)
  4. Quality of Life

Eligibility Criteria
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted: May 18, 2009    Key Record Dates
Last Update Posted: December 24, 2013
Last Verified: December 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
Lapatinib
Liposomal doxorubicin
Trastuzumab
 Doxorubicin
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors