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
  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
Endpoint Classification: Efficacy Study
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:


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 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety profile [ Designated as safety issue: Yes ]
  • Occurrence of clinically apparent brain metastases [ Designated as safety issue: Yes ]
  • Overall survival, progression free survival, clinical benefit (CR, PR or stable disease for at least 24 weeks) [ Designated as safety issue: Yes ]
  • Quality of Life [ Designated as safety issue: Yes ]

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
Genders Eligible for Study:   Both
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

No publications provided

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
Health Authority: Austria: Agency for Health and Food Safety

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
Doxorubicin
Liposomal doxorubicin
Trastuzumab
Lapatinib
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on September 15, 2014