Clinical trial NCT00903656: Lapatinib Plus Caelyx in Patients With Advanced Metastatic Breast Cancer Following Failure of Trastuzumab Therapy
Official title: Lapatinib Plus Caelyx in Patients With Advanced Metastatic Breast Cancer Following Failure of Trastuzumab Therapy - a Phase II Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Metastatic Breast Cancer
Keywords: metastatic breast cancer
Her2
Lapatinib
Caelyx
cardiotoxic
Lead sponsor: Arbeitsgemeinschaft medikamentoese Tumortherapie
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2009-05-18
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
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
Secondary outcomes:
measure: Safety profile
measure: Occurrence of clinically apparent brain metastases
measure: Overall survival, progression free survival, clinical benefit (CR, PR or stable disease for at least 24 weeks)
measure: Quality of Life
Other outcomes:
Locations:
city: Salzburg
country: Austria
facility: Uniklinik Salzburg
Study officials:
affiliation: LKH Feldkirch
name: Alois Lang, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: KH Elisabethinen Linz
name: Rainhard Ziebermayr, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Uniklinik Salzburg
name: Richard Greil, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Univ. Klinikum Graz
name: Hellmut Samonigg, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: AKH Linz
name: Michael Fridrik, Doz.
role: PRINCIPAL_INVESTIGATOR
References: