NCT00903656

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2009

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

May 14, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 18, 2009

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

December 24, 2013

Status Verified

December 1, 2013

Enrollment Period

3 years

First QC Date

May 14, 2009

Last Update Submit

December 23, 2013

Conditions

Metastatic Breast Cancer

Keywords

metastatic breast cancerHer2LapatinibCaelyxcardiotoxic

Outcome Measures

Primary Outcomes (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 Outcomes (4)

  • 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

Study Arms (1)

Caelyx/Lapatinib

EXPERIMENTAL
Drug: doxorubicinhydrochloride, Lapatinib

Interventions

doxorubicinhydrochloride, LapatinibDRUG

Lapatinib 1250mg/d p.o. Caelyx 40 mg/m² i.v. q4w for a maximum of 6 cycles

Caelyx/Lapatinib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uniklinik Salzburg

Salzburg, Salzburg, 5020, Austria

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Lapatinib

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2009

First Posted

May 18, 2009

Study Start

May 1, 2009

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

December 24, 2013

Record last verified: 2013-12

Locations

AU(1)