Breast CancerPhase 2NCT00754702
Vinorelbine Metronomic Plus Lapatinib for Overexpressing HER-2 Metastatic Breast Cancer
A Phase 2 study testing Vinorelbine and Lapatinib in people with Breast Cancer, run by University Hospital of Crete at 2 sites in Greece.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of metronomic oral vinorelbine taken three times a week plus daily lapatinib without break, as salvage treatment in patients with metastatic breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Vinorelbine and Lapatinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesGreece
- Study dates
- Oct 2008to Mar 2011
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically- or cytologically- confirmed metastatic breast adenocarcinoma
- Age 18-75 years
- HER2 status positive according to the local institution reported grade 3+ staining intensity (on a scale of 0 to 3) by means of immunohistochemical analysis or grade 2+ staining intensity by means of immunohistochemical analysis with gene amplification on fluorescence in situ hybridization
- Previous therapies had to include, regimens containing an anthracycline and a taxane
- Previous treatment with trastuzumab, alone or in combination with chemotherapy for locally advanced or metastatic disease, is required
- Measurable disease as defined by the presence of at least one measurable lesion (except bone metastases, ascites or pleural effusions)
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- Performance status (WHO) 0-2
- Adequate liver (serum bilirubin <1.5 times the upper normal limit; AST and ALT <2.5 times the upper normal limit in the absence of demonstrable liver metastases, or <5 times the upper normal limit in the presence of liver metastases); adequate renal function (serum creatinine <1.5 times the upper normal limit); and bone marrow (neutrophils ≥ 1.5x 109 /L, and platelets ≥ 100x 109 /L) function
- No radiation of measurable disease (except brain metastases)
- No progressive brain metastases according to clinical or radiological criteria
- No brain metastases without prior radiation therapy
- Written informed consent
Who cannot join
- Patient unable to take oral medication
- Active infection
- History of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
- Other invasive malignancy except nonmelanoma skin cancer
- Psychiatric illness or social situation that would preclude study compliance
- Pregnant or lactating women
Trial locations and contacts
2 sites in 1 country.
Greece2 sites
"IASO" General Hospital of Athens, 1st Dep of Medical Oncology
Athens
University Hospital of Crete, Dep of Medical Oncology
Heraklion, Crete
About this study
Official title: Vinorelbine Metronomic Plus Lapatinib as Salvage Therapy for Patients With Overexpressing HER-2 Metastatic Breast Cancer. A Multicenter Phase II Study
The purpose of this study is to evaluate the safety and efficacy of metronomic oral vinorelbine taken three times a week plus daily lapatinib without break, as salvage treatment in patients with metastatic breast cancer.
Read the detailed description
Continuous administration of oral vinorelbine, given three times a week (metronomic) is feasible and exceptionally well tolerated at doses up to 50 mg. Early results show activity against refractory tumors and provide evidence towards clinical proof of efficacy for metronomic chemotherapy. Recently, lapatinib plus capecitabine was proven superior to capecitabine alone in women with HER2-positive advanced breast cancer that has progressed after treatment with regimens that included an anthracycline, a taxane, and trastuzumab.
- Conditions
- Breast Cancer
- Being tested
- Vinorelbine, Lapatinib
- Keywords
- Vinorelbine metronomic-lapatinib, Chemotherapy, Targeted therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VinorelbineDrug
Also called Navelbine
Vinorelbine p.o (50 mg 3 times a week) until disease progression or appearance of unacceptable toxicity
LapatinibDrug
Also called Tyverb, Tykerb
Lapatinib p.o every day without interruption disease progression or appearance of unacceptable toxicity
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Vinorelbine metronomic/Lapatinib Receives: Drug: Vinorelbine; Drug: Lapatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
Measured: 3 - 6 month
Secondary outcomes (4)
Progression Free Survival
Measured: 1 year
Toxicity profile
Measured: 21 days
Overall Survival
Measured: 1 year
Quality of life assessment
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2008 (estimated)
- Study startOct 2008
- Primary completionMar 2011
- Study completionMar 2011
Why it stopped: Poor accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of Crete
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vassilis Georgoulias, MD, University Hospital of Crete
- Investigators
- Dimitris Mavrudis, MD, Principal investigator, University Hospital of Crete, Dep of Medical Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00754702
- Sponsor's protocol ID
- CT/08.27
- Status last verified
- Sep 2015
- First submitted
- 17 Sep 2008
- Last updated
- 28 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vinorelbine Metronomic Plus Lapatinib as Salvage Therapy for Patients With Overexpressing HER-2 Metastatic Breast Cancer. A Multicenter Phase II Study
- ClinicalTrials.gov ID
- NCT00754702
- Acronym / sponsor ID
- CT/08.27
- Conditions
- Breast Cancer
- Keywords
- Vinorelbine metronomic-lapatinib, Chemotherapy, Targeted therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor accrual
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University Hospital of CreteUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 18 Sep 2008 (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 purpose of this study is to evaluate the safety and efficacy of metronomic oral vinorelbine taken three times a week plus daily lapatinib without break, as salvage treatment in patients with metastatic breast cancer.
Detailed description
Continuous administration of oral vinorelbine, given three times a week (metronomic) is feasible and exceptionally well tolerated at doses up to 50 mg. Early results show activity against refractory tumors and provide evidence towards clinical proof of efficacy for metronomic chemotherapy. Recently, lapatinib plus capecitabine was proven superior to capecitabine alone in women with HER2-positive advanced breast cancer that has progressed after treatment with regimens that included an anthracycline, a taxane, and trastuzumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Vinorelbine, Drug: LapatinibVinorelbine metronomic/Lapatinib |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histologically- or cytologically- confirmed metastatic breast adenocarcinoma
- Age 18-75 years
- HER2 status positive according to the local institution reported grade 3+ staining intensity (on a scale of 0 to 3) by means of immunohistochemical analysis or grade 2+ staining intensity by means of immunohistochemical analysis with gene amplification on fluorescence in situ hybridization
- Previous therapies had to include, regimens containing an anthracycline and a taxane
- Previous treatment with trastuzumab, alone or in combination with chemotherapy for locally advanced or metastatic disease, is required
Key exclusion criteria (6 listed)
- Patient unable to take oral medication
- Active infection
- History of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
- Other invasive malignancy except nonmelanoma skin cancer
- Psychiatric illness or social situation that would preclude study compliance
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 |
|---|---|---|
| VinorelbineAlso: NavelbineVinorelbine p.o (50 mg 3 times a week) until disease progression or appearance of unacceptable toxicity | Drug | 1 |
| LapatinibAlso: Tyverb, TykerbLapatinib p.o every day without interruption disease progression or appearance of unacceptable toxicity | Drug | 1 |
Primary outcome
Overall response rate
Time frame: 3 - 6 month
4 secondary outcomes
Progression Free Survival
Time frame: 1 year
Toxicity profile
Time frame: 21 days
Overall Survival
Time frame: 1 year
Quality of life assessment
Time frame: 42 days
Results and safety
The study was stopped early (reason given: Poor accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2015.
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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.
Dimitris Mavrudis, MD principal investigator
University Hospital of Crete, Dep of Medical Oncology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vinorelbine and Lapatinib in people with Breast Cancer, run by University Hospital of Crete at 2 sites in Greece.
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 12 inclusion and 6 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 28 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Greece. 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: Poor accrual). 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?
Overall response rate (time frame: 3 - 6 month). 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 28 Sep 2015.