Breast CancerPhase 2NCT00255463
Phase II Neoadjuvant ER+/PgR + Arimidex +/- Iressa Study
A Phase 2 study testing Anastrazole and Gefitinib in people with Breast Cancer, run by AstraZeneca at 34 sites in 7 countries.
Trial summary
The purpose of this study is to compare the changes in a proliferation biomarker in subjects receiving Anastrozole or Anastrozole/ZD1839 combination. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Anastrazole and Gefitinib
- How many people
- 185 participants
- Where
- 34 sitesin 7 countries
- Study dates
- Jan 2004to Nov 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Measurable (stage I-IIIB) non meta static non inflammatory breast cancer
- Patients must post menopausal women who in the opinion of investigator would be likely to benefit from endocrine therapy. Postmenopausal patients are defined as:
- Natural menopause with last menses > 1 year ago,
- Radiation induced oophorectomy with last menses > 1 year ago,
- Serum FSH and LH levels clearly in the postmenopausal range for the institution.
- Bilateral oophorectomy
Who cannot join
- Other current or previous (to last 5 years) malignancies, other metastases, abnormal blood chemistry, lung/ heart/kidney/liver abnormalities,
- Hormonal treatment within the last 2 weeks, previous hormonal treatment for invasive cancer
Trial locations and contacts
34 sites in 7 countries.
34 sites in 7 countries
United Kingdom10 sites
Research Site
Bournemouth
Research Site
Chelmsford, Essex
Research Site
Croydon
Research Site
Dundee
Research Site
Leeds
Research Site
Liverpool
Research Site
London
Research Site
Manchester
Research Site
Newcastle upon Tyne
Research Site
Poole
Spain6 sites
Research Site
A Coruña
Research Site
Jaén, Jaén
Research Site
Santiago de Compostela, A Coruña
Research Site
Seville, Sevilla
Research Site
Valencia, Valencia
Research Site
Zaragoza, Zaragoza
Czechia5 sites
Research Site
Brno
Research Site
Chomutov
Research Site
Ostrava
Research Site
Ostrava - Poruba
Research Site
Prague
France4 sites
Research Site
Clermont-Ferrand
Research Site
Montpellier
Research Site
Tours
Research Site
Villejuif
Hungary3 sites
Research Site
Budapest
Research Site
Debrecen
Research Site
Kecskemét
Portugal3 sites
Research Site
Coimbra
Research Site
Funchal
Research Site
Lisbon
Sweden3 sites
Research Site
Gothenburg
Research Site
Mölndal
Research Site
Stockholm
About this study
Official title: Phase II, Placebo Controlled, Parallel Group, Double Blind, Randomised, Multicentre Trial Comparing the Anastrozole (Arimidex®) Placebo Combination to the Anastrozole - ZD1839 (Iressa™) Combination as Neoadjuvant Treatment in Postmenopausal Women With Stage I-IIIB Breast Cancer and Oestrogen Receptor (ER) and/or Progesterone (PgR) Positive Tumours
The purpose of this study is to compare the changes in a proliferation biomarker in subjects receiving Anastrozole or Anastrozole/ZD1839 combination.
- Conditions
- Breast Cancer
- Being tested
- Anastrazole, Gefitinib
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnastrazoleDrug
GefitinibDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine and compare changes in proliferation marker at 16 weeks in the treatment groups
Secondary outcomes (3)
Tumour response, safety and tolerability, pharmacokinetics, pharmacokinetics and dynamics, oestradiol levels, mastectomy rate.
Comparison of WHO and RECIST criteria,
Exploratory biomarker studies involving genomics, metabolomics and proteomics.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2005 (estimated)
- Study startJan 2004
- Study completionNov 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 185 participants
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- AstraZeneca Iressa Medical Sciences Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00255463
- Sponsor's protocol ID
- 1839IL/0223
- Other IDs
- D7913C00223
- Status last verified
- Apr 2009
- First submitted
- 17 Nov 2005
- Last updated
- 23 Apr 2009
- Results posted
- 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
- Phase II, Placebo Controlled, Parallel Group, Double Blind, Randomised, Multicentre Trial Comparing the Anastrozole (Arimidex®) Placebo Combination to the Anastrozole - ZD1839 (Iressa™) Combination as Neoadjuvant Treatment in Postmenopausal Women With Stage I-IIIB Breast Cancer and Oestrogen Receptor (ER) and/or Progesterone (PgR) Positive Tumours
- ClinicalTrials.gov ID
- NCT00255463
- Acronym / sponsor ID
- 1839IL/0223
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 185 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jan 2004
- Study completion
- Nov 2005 (actual)
- First posted
- 21 Nov 2005 (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 compare the changes in a proliferation biomarker in subjects receiving Anastrozole or Anastrozole/ZD1839 combination.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Measurable (stage I-IIIB) non meta static non inflammatory breast cancer
- Patients must post menopausal women who in the opinion of investigator would be likely to benefit from endocrine therapy. Postmenopausal patients are defined as:
- Natural menopause with last menses > 1 year ago,
- Radiation induced oophorectomy with last menses > 1 year ago,
- Serum FSH and LH levels clearly in the postmenopausal range for the institution.
Key exclusion criteria (2 listed)
- Other current or previous (to last 5 years) malignancies, other metastases, abnormal blood chemistry, lung/ heart/kidney/liver abnormalities,
- Hormonal treatment within the last 2 weeks, previous hormonal treatment for invasive cancer
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 |
|---|---|---|
| Anastrazole | Drug | – |
| Gefitinib | Drug | – |
Primary outcome
To determine and compare changes in proliferation marker at 16 weeks in the treatment groups
3 secondary outcomes
Tumour response, safety and tolerability, pharmacokinetics, pharmacokinetics and dynamics, oestradiol levels, mastectomy rate.
Comparison of WHO and RECIST criteria,
Exploratory biomarker studies involving genomics, metabolomics and proteomics.
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.
AstraZeneca Iressa Medical Sciences Director, MD study director
AstraZeneca
34 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anastrazole and Gefitinib in people with Breast Cancer, run by AstraZeneca at 34 sites in 7 countries.
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 6 inclusion and 2 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.
Where is the study taking place?
The record lists 34 sites in United Kingdom, Spain, Czechia, France, Hungary and 2 more countries. 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?
To determine and compare changes in proliferation marker at 16 weeks in the treatment groups. 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.