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

May 14, 2009
December 23, 2013
May 2009
May 2012   (final data collection date for primary 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 [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00903656 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Metastatic Breast Cancer
Drug: doxorubicinhydrochloride, Lapatinib
Lapatinib 1250mg/d p.o. Caelyx 40 mg/m² i.v. q4w for a maximum of 6 cycles
Experimental: Caelyx/Lapatinib
Intervention: Drug: doxorubicinhydrochloride, Lapatinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
24
May 2012
May 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT00903656
AGMT_MBC-5, EudraCT 2008-004530-25
No
Arbeitsgemeinschaft medikamentoese Tumortherapie
Arbeitsgemeinschaft medikamentoese Tumortherapie
GlaxoSmithKline
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
Arbeitsgemeinschaft medikamentoese Tumortherapie
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP