Breast CancerPhase 2NCT00637026
Ph II Early BC Pre-Surgical Biologic Study
A Phase 2 study testing Gefitinib in people with Breast Cancer, run by AstraZeneca.
Trial summary
A pre-surgery study to assess changes that occur in human breast cancer material and normal skin after a short course of treatment with Iressa. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Gefitinib
- How many people
- 65 participants
- Where
- No sites listed yet
- Study dates
- Jul 2003to Feb 2005
- 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
- Invasive breast cancer, Aged 18 years or older, Not more than 28 days from initial diagnosis
Who cannot join
- Pregnant or lactating patients, Prior or current radiotherapy for breast cancer, Known allergy reaction to Iressa
About this study
Official title: A PreSurgical Study to Evaluate Molecular Alterations That Occur in Human Breast Cancer Tissue and Normal Skin After Short Term Exposure to ZD1839 (IRESSA) and to Correlate These Alterations With Pharmacokinetic Parameters.
A pre-surgery study to assess changes that occur in human breast cancer material and normal skin after a short course of treatment with Iressa.
- Conditions
- Breast Cancer
- Being tested
- Gefitinib
- Keywords
- Iressa, Gefitinib, Breast Cancer, Surgery
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GefitinibDrug
Iressa
What is being measured
The primary outcome is the main question the study is designed to answer.
Molecular alterations occuring in breast cancer tissue following Iressa treatment
Measured: At time of diagnosis and time of patient surgery
Secondary outcomes (3)
Molecular alterations occurring in normal skin tissue following Iressa treatment
Measured: At time of diagnosis and time of patient surgery
To correlate molecular changes with pharmacokinetic parameters
Measured: At time of diagnosis and time of patient surgery
To evaluate tolerability of short term Iressa treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2008 (estimated)
- Study startJul 2003
- Study completionFeb 2005
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.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cancer International Research Group (CIRG)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00637026
- Sponsor's protocol ID
- 1839IL/0219
- Status last verified
- Apr 2009
- First submitted
- 10 Mar 2008
- Last updated
- 23 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PreSurgical Study to Evaluate Molecular Alterations That Occur in Human Breast Cancer Tissue and Normal Skin After Short Term Exposure to ZD1839 (IRESSA) and to Correlate These Alterations With Pharmacokinetic Parameters.
- ClinicalTrials.gov ID
- NCT00637026
- Acronym / sponsor ID
- 1839IL/0219
- Conditions
- Breast Cancer
- Keywords
- Iressa, Gefitinib, Breast Cancer, Surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Cancer International Research Group (CIRG)
- Study start
- Jul 2003
- Study completion
- Feb 2005 (actual)
- First posted
- 17 Mar 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.
A pre-surgery study to assess changes that occur in human breast cancer material and normal skin after a short course of treatment with Iressa.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Invasive breast cancer, Aged 18 years or older, Not more than 28 days from initial diagnosis
Key exclusion criteria (1 listed)
- Pregnant or lactating patients, Prior or current radiotherapy for breast cancer, Known allergy reaction to Iressa
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 |
|---|---|---|
| GefitinibIressa | Drug | – |
Primary outcome
Molecular alterations occuring in breast cancer tissue following Iressa treatment
Time frame: At time of diagnosis and time of patient surgery
3 secondary outcomes
Molecular alterations occurring in normal skin tissue following Iressa treatment
Time frame: At time of diagnosis and time of patient surgery
To correlate molecular changes with pharmacokinetic parameters
Time frame: At time of diagnosis and time of patient surgery
To evaluate tolerability of short term Iressa 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 23 Apr 2009.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gefitinib in people with Breast Cancer, run by AstraZeneca.
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 1 inclusion and 1 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 23 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
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?
Molecular alterations occuring in breast cancer tissue following Iressa treatment (time frame: At time of diagnosis and time of patient surgery). 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 23 Apr 2009.