Lapatinib Plus Caelyx in Patients With Advanced Metastatic Breast Cancer Following Failure of Trastuzumab Therapy
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ClinicalTrials.gov Identifier: NCT00903656 |
Recruitment Status
:
Terminated
(Caelyx was not available anymore)
First Posted
: May 18, 2009
Last Update Posted
: December 24, 2013
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Metastatic Breast Cancer | Drug: doxorubicinhydrochloride, Lapatinib | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 24 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (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 |
Study Start Date : | May 2009 |
Actual Primary Completion Date : | May 2012 |
Actual Study Completion Date : | May 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: Caelyx/Lapatinib |
Drug: doxorubicinhydrochloride, Lapatinib
Lapatinib 1250mg/d p.o. Caelyx 40 mg/m² i.v. q4w for a maximum of 6 cycles
|
- 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
- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00903656
Austria | |
Uniklinik Salzburg | |
Salzburg, Austria, 5020 |
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 |
Responsible Party: | Arbeitsgemeinschaft medikamentoese Tumortherapie |
ClinicalTrials.gov Identifier: | NCT00903656 History of Changes |
Other Study ID Numbers: |
AGMT_MBC-5 EudraCT 2008-004530-25 |
First Posted: | May 18, 2009 Key Record Dates |
Last Update Posted: | December 24, 2013 |
Last Verified: | December 2013 |
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 Lapatinib Liposomal doxorubicin Trastuzumab |
Doxorubicin Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antibiotics, Antineoplastic Topoisomerase II Inhibitors Topoisomerase Inhibitors |