Metastatic Breast CancerPhase 2NCT00903656
Lapatinib Plus Caelyx in Patients With Advanced Metastatic Breast Cancer Following Failure of Trastuzumab Therapy
A Phase 2 study testing doxorubicinhydrochloride, Lapatinib in people with Metastatic Breast Cancer, run by Arbeitsgemeinschaft medikamentoese Tumortherapie at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- doxorubicinhydrochloride, Lapatinib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteAustria
- Study dates
- May 2009to May 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Metastatic Breast Cancer
- Being tested
- doxorubicinhydrochloride, Lapatinib
- Keywords
- metastatic breast cancer, Her2, Lapatinib, Caelyx, cardiotoxic
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
doxorubicinhydrochloride, LapatinibDrug
Lapatinib 1250mg/d p.o. Caelyx 40 mg/m² i.v. q4w for a maximum of 6 cycles
| Study group | Role | What they receive |
|---|---|---|
| Caelyx/Lapatinib | Experimental | Not described Receives: Drug: doxorubicinhydrochloride, Lapatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2009 (estimated)
- Study startMay 2009
- Primary completionMay 2012
- Study completionMay 2012
Why it stopped: Caelyx was not available anymore
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arbeitsgemeinschaft medikamentoese Tumortherapie
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Alois Lang, Dr, Principal investigator, LKH FeldkirchRainhard Ziebermayr, Dr., Principal investigator, KH Elisabethinen LinzRichard Greil, Prof., Principal investigator, Uniklinik SalzburgHellmut Samonigg, Prof., Principal investigator, Univ. Klinikum GrazMichael Fridrik, Doz., Principal investigator, AKH Linz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00903656
- Sponsor's protocol ID
- AGMT_MBC-5
- Other IDs
- EudraCT 2008-004530-25
- Status last verified
- Dec 2013
- First submitted
- 14 May 2009
- Last updated
- 24 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lapatinib Plus Caelyx in Patients With Advanced Metastatic Breast Cancer Following Failure of Trastuzumab Therapy - a Phase II Study
- ClinicalTrials.gov ID
- NCT00903656
- Acronym / sponsor ID
- AGMT_MBC-5
- Conditions
- Metastatic Breast Cancer
- Keywords
- metastatic breast cancer, Her2, Lapatinib, Caelyx, cardiotoxic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Caelyx was not available anymore
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Arbeitsgemeinschaft medikamentoese TumortherapieUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- May 2009
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 18 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Caelyx/Lapatinib | Experimental | Drug: doxorubicinhydrochloride, Lapatinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| doxorubicinhydrochloride, LapatinibLapatinib 1250mg/d p.o. Caelyx 40 mg/m² i.v. q4w for a maximum of 6 cycles | Drug | Caelyx/Lapatinib |
Primary outcome
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
4 secondary outcomes
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
Results and safety
The study was stopped early (reason given: Caelyx was not available anymore). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alois Lang, Dr principal investigator
LKH Feldkirch
Rainhard Ziebermayr, Dr. principal investigator
KH Elisabethinen Linz
Richard Greil, Prof. principal investigator
Uniklinik Salzburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing doxorubicinhydrochloride, Lapatinib in people with Metastatic Breast Cancer, run by Arbeitsgemeinschaft medikamentoese Tumortherapie at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Caelyx was not available anymore). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2013.