Metastatic Breast CancerPhase 2NCT00694252
Lapatinib and Circulating Tumor Cells in Breast Cancer
A Phase 2 study testing Lapatinib in people with Metastatic Breast Cancer, run by University Hospital of Crete at 1 site in Greece.
Trial summary
This study will evaluate the efficacy of lapatinib in eradicating chemo- resistant tumour cells circulating in the blood of patients with breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Lapatinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGreece
- Study dates
- Jul 2008to Nov 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of written informed consent
- Histologically or cytologically confirmed breast cancer
- Metastatic breast cancer (stage IIIB and IV). EGFR and/or HER-2 expression on the primary tumor is not mandatory.
- Patients should have received at least one course of standard systemic chemotherapy for their metastatic disease. Prior hormonal therapy is allowed.
- Patients should have achieved objective response (CR or PR) or stable disease to previous first or second line treatment.
- There should be at least one month between the end of chemotherapy treatment and trial entry. In case of prior Herceptin administration, 3 months are required to have elapsed before study entry.
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- Detection of ≥5 cells/7.5ml of peripheral blood detected by Cell Search System despite the previous administration of chemotherapy and/or hormonal therapy.
- HER-2 expression on CTCs.
- Age 18 years and over
- Adequate Haematological function, Absolute neutrophil count ≥1.5 x 109/L, Platelet count ≥100 x 109/L and Haemoglobin ≥9 g/dL (may be transfused to maintain or exceed this level)
- Adequate Liver Function, total bilirubin <1.5 x upper limit of normal, AST and ALT <2.5 x upper limit of normal in patients without liver metastases and <5 x upper limit of normal in patients with liver metastases
- Adequate Renal function, Serum creatinine ≤1.25 x upper limit of normal or calculated creatinine clearance ≥50 mL/min
- LVEF within institutional normal range
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Life expectancy of at least 12 weeks
Who cannot join
- Any concurrent systemic treatment for breast cancer (including chemotherapy, radiotherapy, hormonotherapy, monoclonal antibodies)
- Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
- Any unresolved chronic toxicity greater than Grade 2 (NCI- CTCAE) from previous anticancer therapy (except alopecia)
- Any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
- Pregnancy or breast feeding (women of child-bearing potential). Women of childbearing potential must practice acceptable methods of birth control to prevent pregnancy
- Treatment with any other investigational agent, or participation in another clinical trial within 28 days prior to enrolment
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- Known hypersensitivity to drugs chemically related to lapatinib
- Concomitant requirement for medication classified as CYP3A4 inducers or inhibitors
- Evidence of any other disease, neurological or metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related complications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Feasibility Study to Evaluate the Efficacy of Lapatinib in Eliminating Cytokeratin-positive Tumour Cells Circulating in the Blood of Women With Breast Cancer
This study will evaluate the efficacy of lapatinib in eradicating chemo- resistant tumour cells circulating in the blood of patients with breast cancer.
Read the detailed description
Breast cancer is considered a systemic disease since early tumour cell dissemination may occur even in patients with small tumours; several investigators using immunocytochemistry or real time PCR (RT-PCR) have shown that cytokeratin-positive epithelial cells could be identified in the bone marrow aspirates or the peripheral blood of otherwise metastases-free patients with stage I and II breast cancer. The clinical importance of the immunocytochemical detection of occult tumour cells in the bone marrow has been confirmed in many prospective studies to represent an independent predictive and prognostic factor for distant relapse and reduced survival.
Patients with metastatic breast cancer who have persistent detection of tumour cells in the peripheral blood (≥5 cells/7.5 ml) despite at least one line of chemotherapy will receive lapatinib for a minimum of one month unless disease progression occurs at an earlier time point.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Lapatinib
- Keywords
- Breast cancer, Tykerb, CTCs
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LapatinibDrug
Also called Tykerb, Tyverb, GW572016
Patients will receive lapatinib monotherapy 1500 mg/day for a period of at least one month depending on their response and the clinical status of their disease.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Lapatinib Receives: Drug: Lapatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of lapatinib by quantitative analysis of circulating tumour cells in the blood.The efficacy will be measured before, during and after the completion of treatment
Measured: 2 months
Secondary outcomes (2)
Correlation of the levels of CTCs with the PFS of the patients
Measured: 1 year
Assessment of the safety of lapatinib administration in this patient population.
Measured: During treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2008 (estimated)
- Study startJul 2008
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 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
- Sofia Aggelaki, MD, Principal investigator, University Hospital of Crete
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00694252
- Sponsor's protocol ID
- CT/07.15
- Status last verified
- Sep 2015
- First submitted
- 6 Jun 2008
- Last updated
- 28 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Agelaki S, Kalykaki A, Markomanolaki H, Papadaki MA, Kallergi G, Hatzidaki D, Kalbakis K, Mavroudis D, Georgoulias V. Efficacy of Lapatinib in Therapy-Resistant HER2-Positive Circulating Tumor Cells in Metastatic Breast Cancer. PLoS One. 2015 Jun 17;10(6):e0123683. doi: 10.1371/journal.pone.0123683. eCollection 2015.
PubMed 26083256
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
- A Pilot Feasibility Study to Evaluate the Efficacy of Lapatinib in Eliminating Cytokeratin-positive Tumour Cells Circulating in the Blood of Women With Breast Cancer
- ClinicalTrials.gov ID
- NCT00694252
- Acronym / sponsor ID
- CT/07.15
- Conditions
- Metastatic Breast Cancer
- Keywords
- Breast cancer, Tykerb, CTCs
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital of CreteUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 10 Jun 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.
This study will evaluate the efficacy of lapatinib in eradicating chemo- resistant tumour cells circulating in the blood of patients with breast cancer.
Detailed description
Breast cancer is considered a systemic disease since early tumour cell dissemination may occur even in patients with small tumours; several investigators using immunocytochemistry or real time PCR (RT-PCR) have shown that cytokeratin-positive epithelial cells could be identified in the bone marrow aspirates or the peripheral blood of otherwise metastases-free patients with stage I and II breast cancer. The clinical importance of the immunocytochemical detection of occult tumour cells in the bone marrow has been confirmed in many prospective studies to represent an independent predictive and prognostic factor for distant relapse and reduced survival.
Patients with metastatic breast cancer who have persistent detection of tumour cells in the peripheral blood (≥5 cells/7.5 ml) despite at least one line of chemotherapy will receive lapatinib for a minimum of one month unless disease progression occurs at an earlier time point.
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: LapatinibLapatinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Provision of written informed consent
- Histologically or cytologically confirmed breast cancer
- Metastatic breast cancer (stage IIIB and IV). EGFR and/or HER-2 expression on the primary tumor is not mandatory.
- Patients should have received at least one course of standard systemic chemotherapy for their metastatic disease. Prior hormonal therapy is allowed.
- Patients should have achieved objective response (CR or PR) or stable disease to previous first or second line treatment.
Key exclusion criteria (9 listed)
- Any concurrent systemic treatment for breast cancer (including chemotherapy, radiotherapy, hormonotherapy, monoclonal antibodies)
- Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
- Any unresolved chronic toxicity greater than Grade 2 (NCI- CTCAE) from previous anticancer therapy (except alopecia)
- Any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
- Pregnancy or breast feeding (women of child-bearing potential). Women of childbearing potential must practice acceptable methods of birth control to prevent pregnancy
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 |
|---|---|---|
| LapatinibAlso: Tykerb, Tyverb, GW572016Patients will receive lapatinib monotherapy 1500 mg/day for a period of at least one month depending on their response and the clinical status of their disease. | Drug | 1 |
Primary outcome
Efficacy of lapatinib by quantitative analysis of circulating tumour cells in the blood.The efficacy will be measured before, during and after the completion of treatment
Time frame: 2 months
2 secondary outcomes
Correlation of the levels of CTCs with the PFS of the patients
Time frame: 1 year
Assessment of the safety of lapatinib administration in this patient population.
Time frame: During treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2015.
- Derived from this study: PubMed 26083256Agelaki S, Kalykaki A, Markomanolaki H, Papadaki MA, Kallergi G, Hatzidaki D, Kalbakis K, Mavroudis D, Georgoulias V. Efficacy of Lapatinib in Therapy-Resistant HER2-Positive Circulating Tumor Cells in Metastatic Breast Cancer. PLoS One. 2015 Jun 17;10(6):e0123683. doi: 10.1371/journal.pone.0123683. eCollection 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.
Sofia Aggelaki, MD principal investigator
University Hospital of Crete
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 Lapatinib in people with Metastatic Breast Cancer, run by University Hospital of Crete at 1 site 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 15 inclusion and 9 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: finished, 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 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 lapatinib by quantitative analysis of circulating tumour cells in the blood.The efficacy will be measured before, during and after the completion of treatment (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00694252, which also lists 1 linked publication.
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.