Breast CancerPhase 2NCT00247481
ZD1839 (Iressa™) In Combination With Docetaxel As First-Line Treatment In Patients With Metastatic Breast Cancer
A Phase 2 study testing Gefitinib and Docetaxel in people with Breast Cancer, run by AstraZeneca at 5 sites in France.
Trial summary
This is a multicentre, randomised (2:1), double blind, non-comparative phase II trial of ZD1839 and placebo in combination with chemotherapy in patients with metastatic breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Gefitinib and Docetaxel
- How many people
- 77 participants
- Where
- 5 sitesFrance
- Study dates
- Sep 2002to Jun 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed breast cancer at a metastatic stage.
- Uni- or bi-dimensionally measurable lesions (10 mm or 20 mm) according to the Response Evaluation Criteria in Solid Tumours (RECIST) criteria
- World Health Organisation (WHO) performance status (PS) of 0 to 2
- Life expectancy of greater than 12 weeks
- Normal cardiac function (left ventricular ejection fraction [LVEF] by isotopic examination greater than or equal to 55%)
Who cannot join
- Symptomatic lepto-meningeal metastasis
- Concomitant infectious disease
- Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy
- Incomplete healing from previous oncologic or other surgery
- Absolute neutrophil count (ANC) less than 1.5 x 109/litre (L) or platelets less than 100 x 109/L
- Serum creatinine greater than 1.5 times the ULRR or clearance < 60 ml/min
Show all 9Show fewer
- ALT or AST greater than 2.5 times the ULRR
- ALP > 5 times the ULRR
- ALP > 2.5 times the ULRR and ALT or AST greater than 1.5 times the ULRR
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Research Site
Dijon
Research Site
Paris
Research Site
Saint-Cloud
Research Site
Saint-Germain-en-Laye
Research Site
Villejuif
About this study
Official title: A Multicentre, Randomised, Double-Blind, Non-Comparative Phase II Trial Of ZD1839 (Iressa™) And Placebo In Combination With Chemotherapy With Docetaxel As First-Line Treatment In Patients With Metastatic Breast Cancer
This is a multicentre, randomised (2:1), double blind, non-comparative phase II trial of ZD1839 and placebo in combination with chemotherapy in patients with metastatic breast cancer.
- Conditions
- Breast Cancer
- Keywords
- Metastatic Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
What is being measured
The primary outcome is the main question the study is designed to answer.
To estimate the overall response rates (complete response [CR] and partial response [PR]) in the ZD1839-treated group and the placebo-treated group.
Secondary outcomes (4)
o To assess progression-free survival (PFS) in the ZD1839-treated group and the placebo-treated group.
o To estimate the duration of response in the ZD1839-treated group and the placebo treated group
o To estimate overall survival in the ZD1839-treated group and the placebo-treated group
o To estimate time to treatment failure (TTF) in the ZD1839-treated group and the placebo treated group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2005 (estimated)
- Study startSep 2002
- Study completionJun 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
- 77 participants
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- AstraZeneca France Medical Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00247481
- Sponsor's protocol ID
- D7913C00148
- Other IDs
- 1839IL/0148
- Status last verified
- Apr 2009
- First submitted
- 1 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
- A Multicentre, Randomised, Double-Blind, Non-Comparative Phase II Trial Of ZD1839 (Iressa™) And Placebo In Combination With Chemotherapy With Docetaxel As First-Line Treatment In Patients With Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00247481
- Acronym / sponsor ID
- D7913C00148
- Conditions
- Breast Cancer
- Keywords
- Metastatic Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Sep 2002
- Study completion
- Jun 2005 (actual)
- First posted
- 2 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.
This is a multicentre, randomised (2:1), double blind, non-comparative phase II trial of ZD1839 and placebo in combination with chemotherapy in patients with metastatic breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically or cytologically confirmed breast cancer at a metastatic stage.
- Uni- or bi-dimensionally measurable lesions (10 mm or 20 mm) according to the Response Evaluation Criteria in Solid Tumours (RECIST) criteria
- World Health Organisation (WHO) performance status (PS) of 0 to 2
- Life expectancy of greater than 12 weeks
- Normal cardiac function (left ventricular ejection fraction [LVEF] by isotopic examination greater than or equal to 55%)
Key exclusion criteria (9 listed)
- Symptomatic lepto-meningeal metastasis
- Concomitant infectious disease
- Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy
- Incomplete healing from previous oncologic or other surgery
- Absolute neutrophil count (ANC) less than 1.5 x 109/litre (L) or platelets less than 100 x 109/L
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 |
|---|---|---|
| Gefitinib | Drug | – |
| Docetaxel | Drug | – |
Primary outcome
To estimate the overall response rates (complete response [CR] and partial response [PR]) in the ZD1839-treated group and the placebo-treated group.
4 secondary outcomes
o To assess progression-free survival (PFS) in the ZD1839-treated group and the placebo-treated group.
o To estimate the duration of response in the ZD1839-treated group and the placebo treated group
o To estimate overall survival in the ZD1839-treated group and the placebo-treated group
o To estimate time to treatment failure (TTF) in the ZD1839-treated group and the placebo treated group
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 France Medical Director, MD study director
AstraZeneca
5 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 Gefitinib and Docetaxel in people with Breast Cancer, run by AstraZeneca at 5 sites in France.
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 5 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 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 5 sites in France. 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 estimate the overall response rates (complete response [CR] and partial response [PR]) in the ZD1839-treated group and the placebo-treated group.. 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.