Breast CancerPhase 2NCT00428896
A Feasibility Study With Iressa in Resistant Cytokeratin-Positive Tumor Cells Circulating in the Blood of Women With Breast Cancer
A Phase 2 study testing ZD1839 in people with Breast Cancer, run by University Hospital of Crete at 1 site in Greece.
Trial summary
Based on preclinical data, ZD1839 is considered a novel and promising therapeutic approach with potential application in the treatment of human breast cancer. Therefore it could be very important and clinically relevant to know if ZD1839 is capable of eliminating occult tumour cells circulating in the blood of breast… 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?
- ZD1839
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteGreece
- Study dates
- Apr 2005to Mar 2008
- 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
- Provision of written informed consent
- Histologically or cytologically confirmed breast cancer
- Metastatic breast cancer (stage IIIB and IV)
- Patients should have received at least one course of standard systemic chemotherapy for their metastatic disease. There should be at least one month between end of chemotherapy treatment and trial entry.
- ER+ve patients should have received adjuvant hormonal treatment
- Detection of CK-19 mRNA positive cells in the blood by real time PCR despite the previous administration of chemotherapy and if appropriate hormonal therapy
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- Aged 18 years and over
- Paraffin-embedded tissue available for tumour histology (EGFR testing, ER, PgR, Her-2-neu testing)
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2
- Patients willing to undergo regular detection of circulating occult tumour cells in the blood by immunocytochemistry and/or RT-PCR
- Life expectancy of at least 12 weeks
Who cannot join
- Any concurrent systemic treatment for breast cancer (including chemotherapy, radiotherapy, hormonotherapy, monoclonal antibodies)
- Known severe hypersensitivity to ZD1839 or any of the excipients of this product
- Any evidence of clinically active interstitial lung disease (patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded)
- 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 common toxicity criteria (CTC) grade 2 from previous anticancer therapy (except alopecia)
- Serum bilirubin greater than 1.5 times the upper limit of reference range (ULRR)
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- As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
- Alanine amino transferase (ALT) or aspartate amino transferase (AST) greater than 3 times the ULRR.
- Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study
- Pregnancy or breast feeding (women of child-bearing potential). Women of childbearing potential must practice acceptable methods of birth control to prevent pregnancy
- Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or St John's Wort
- Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Feasibility Study to Evaluate the Efficacy of ZD1839 (IRESSA) in Eliminating Chemo- and Hormone- Resistant Cytokeratin-Positive Tumour Cells Circulating in the Blood of Women With Breast Cancer
Based on preclinical data, ZD1839 is considered a novel and promising therapeutic approach with potential application in the treatment of human breast cancer. Therefore it could be very important and clinically relevant to know if ZD1839 is capable of eliminating occult tumour cells circulating in the blood of breast cancer patients
- Conditions
- Breast Cancer
- Being tested
- ZD1839
- Keywords
- Breast cancer, iressa circulating tumor cells
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZD1839Drug
Also called Iressa
ZD1839 will be given at the dose of 250mg/day for a minimum of 3 months
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | ZD1839 Receives: Drug: ZD1839 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of ZD1839 by quantitative analysis of CK-19 mRNA CTCs
Measured: Detection of CK-19 mRNA CTCs during and after the completion of ZD1839 treatment
Secondary outcomes (3)
To assess duration of response by means of CK-19 mRNA detection
Measured: 6 months
To assess Progression Free Survival by means of CK-19 mRNA detection
Measured: 1 year
To assess the safety of ZD1839 administration in this patient population
Measured: Toxicity assessment every month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2007 (estimated)
- Study startApr 2005
- Primary completionMar 2008
- Study completionMar 2008
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 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
- University Hospital of Crete
- Sponsor type
- University, hospital or other
- Investigators
- Vassilis Georgoulias, MD, Principal investigator, University Hospital of Crete, Dep of Medical Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00428896
- Sponsor's protocol ID
- MICRO
- Status last verified
- Jul 2008
- First submitted
- 29 Jan 2007
- Last updated
- 21 Jul 2008
- Results posted
- No
Publications
Kalykaki A, Agelaki S, Kallergi G, Xyrafas A, Mavroudis D, Georgoulias V. Elimination of EGFR-expressing circulating tumor cells in patients with metastatic breast cancer treated with gefitinib. Cancer Chemother Pharmacol. 2014 Apr;73(4):685-93. doi: 10.1007/s00280-014-2387-y. Epub 2014 Feb 4.
PubMed 24493157
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Feasibility Study to Evaluate the Efficacy of ZD1839 (IRESSA) in Eliminating Chemo- and Hormone- Resistant Cytokeratin-Positive Tumour Cells Circulating in the Blood of Women With Breast Cancer
- ClinicalTrials.gov ID
- NCT00428896
- Acronym / sponsor ID
- MICRO
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, iressa circulating tumor cells
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Hospital of CreteUniversity, hospital or other
- Study start
- Apr 2005
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 30 Jan 2007 (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.
Based on preclinical data, ZD1839 is considered a novel and promising therapeutic approach with potential application in the treatment of human breast cancer. Therefore it could be very important and clinically relevant to know if ZD1839 is capable of eliminating occult tumour cells circulating in the blood of breast cancer patients
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ZD1839ZD1839 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Provision of written informed consent
- Histologically or cytologically confirmed breast cancer
- Metastatic breast cancer (stage IIIB and IV)
- Patients should have received at least one course of standard systemic chemotherapy for their metastatic disease. There should be at least one month between end of chemotherapy treatment and trial entry.
- ER+ve patients should have received adjuvant hormonal treatment
Key exclusion criteria (12 listed)
- Any concurrent systemic treatment for breast cancer (including chemotherapy, radiotherapy, hormonotherapy, monoclonal antibodies)
- Known severe hypersensitivity to ZD1839 or any of the excipients of this product
- Any evidence of clinically active interstitial lung disease (patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded)
- 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 common toxicity criteria (CTC) grade 2 from previous anticancer therapy (except alopecia)
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 |
|---|---|---|
| ZD1839Also: IressaZD1839 will be given at the dose of 250mg/day for a minimum of 3 months | Drug | 1 |
Primary outcome
Efficacy of ZD1839 by quantitative analysis of CK-19 mRNA CTCs
Time frame: Detection of CK-19 mRNA CTCs during and after the completion of ZD1839 treatment
3 secondary outcomes
To assess duration of response by means of CK-19 mRNA detection
Time frame: 6 months
To assess Progression Free Survival by means of CK-19 mRNA detection
Time frame: 1 year
To assess the safety of ZD1839 administration in this patient population
Time frame: Toxicity assessment every month
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 21 Jul 2008.
- Derived from this study: PubMed 24493157Kalykaki A, Agelaki S, Kallergi G, Xyrafas A, Mavroudis D, Georgoulias V. Elimination of EGFR-expressing circulating tumor cells in patients with metastatic breast cancer treated with gefitinib. Cancer Chemother Pharmacol. 2014 Apr;73(4):685-93. doi: 10.1007/s00280-014-2387-y. Epub 2014 Feb 4.
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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.
Vassilis Georgoulias, MD principal investigator
University Hospital of Crete, Dep of Medical Oncology
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 ZD1839 in people with 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 11 inclusion and 12 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 21 Jul 2008. 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 ZD1839 by quantitative analysis of CK-19 mRNA CTCs (time frame: Detection of CK-19 mRNA CTCs during and after the completion of ZD1839 treatment). 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 NCT00428896, 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 21 Jul 2008.