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

Sponsor
Arbeitsgemeinschaft medikamentoese Tumortherapie
Study ID
NCT00903656
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
May 31, 2009
Status verified
Dec 2013
Primary completion
May 31, 2012
Completion
May 31, 2012

Study Design

Enrollment
24 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Caelyx/Lapatinib

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

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