Breast CancerPhase 2NCT00234403
A Trial to Evaluate the Combination of Iressa & Faslodex® in Patients With Advanced or Metastatic Breast Cancer
A Phase 2 study testing gefitinib and fulvestrant in people with Breast Cancer, run by AstraZeneca at 7 sites in Spain.
Trial summary
The progression free survival and efficacy of 250 mg ZD1839 in combination with a fixed dose of fulvestrant 250 mg im once a month will be evaluated in female patients with histologically-confirmed advanced or metastatic, ER and/or PR positive breast cancer 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 and fulvestrant
- How many people
- 60 participants
- Where
- 7 sitesSpain
- Study dates
- May 2004to Oct 2007
- 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
- Histologically confirmed advanced or metastatic breast cancer
- postmenopausal females with amenorrhoea > 12 months and an intact uterus
- FSH levels within postmenopausal range or have undergone a bilateral oophorectomy
- ER \&/or PR positive
- previous adjuvant hormone therapy > 12 months prior to enrolment
- previous adjuvant chemotherapy > 6 months prior to enrolment
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- measurable disease according to RECIST and/or non measurable bone disease
- life expectancy of at least 12 weeks
- World Health Organisation (WHO) performance status (PS) of 0 to 1.
Who cannot join
- Male
- life-threatening metastatic visceral disease
- evidence of clinically active interstitial lung disease
- ER and PR negative
- treatment with LHRH analogues < 3 months prior to enrolment
- patients who have restarted menses or do not have FSH levels within the postmenopausal range
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- treatment with strontium - 90 (or other radio pharmaceutical) within the previous 3 months
- Treatment with hormonotherapy and/or chemotherapy for advanced disease
- extensive radiotherapy to measurable lesions within the last 4 weeks (i.e. >30% of bone marrow, e.g. whole of pelvis or half of spine)
- currently receiving oestrogen replacement therapy
- treatment with a non-approved or experimental drug within 4 weeks before enrolment
- absolute neutrophil count (ANC) less than 1.5 x 109/litre (L) or platelets less than 100 x 109/L , serum bilirubin greater than 1.25 times the upper limit of reference range (ULRR, serum creatinine greater than 1.5 mg/dL, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.5 times the ULRR if no demonstrable liver metastases, or greater than 5 times the ULRR in the presence of liver metastases, history of bleeding diathesis or long term or present anticoagulant therapy (other than antiplatelet therapy
- any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy
- concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, known
- severe hypersensitivity to ZD1839 or fulvestrant or any of the excipients of this product.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Spain7 sites
Investigative Site
Alicante
Investigative Site
Girona
Investigative Site
Jaén
Investigative Site
Madrid
Investigative Site
Seville
Investigative Site
Valencia
Investigative Site
Zaragoza
About this study
Official title: A Phase II Trial to Evaluate the Combination of ZD1839 (Iressa) and Fulvestrant (Faslodex®) in Patients With Advanced or Metastatic Breast Cancer
The progression free survival and efficacy of 250 mg ZD1839 in combination with a fixed dose of fulvestrant 250 mg im once a month will be evaluated in female patients with histologically-confirmed advanced or metastatic, ER and/or PR positive breast cancer
- Conditions
- Breast Cancer
- Being tested
- gefitinib and fulvestrant
- Keywords
- Advanced breast cancer, Metastatic breast cancer, ER positive breast cancer, PR positive 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.
gefitinib and fulvestrantDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the progression-free survival (PFS) of the combination of 250 mg ZD1839 and fulvestrant in patients with advanced or metastatic breast cancer
Secondary outcomes (4)
To estimate the objective response rate (complete response [CR] and partial response [PR]) at trial closure.
To estimate the disease control rate at trial closure.
To estimate overall survival.
To evaluate the safety & tolerability of the combination gefitinib and fulvestrant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2005 (estimated)
- Study startMay 2004
- Study completionOct 2007
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- AstraZeneca Spain Medical Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00234403
- Sponsor's protocol ID
- 1839IL/0141
- Status last verified
- Apr 2009
- First submitted
- 5 Oct 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 Phase II Trial to Evaluate the Combination of ZD1839 (Iressa) and Fulvestrant (Faslodex®) in Patients With Advanced or Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00234403
- Acronym / sponsor ID
- 1839IL/0141
- Conditions
- Breast Cancer
- Keywords
- Advanced breast cancer, Metastatic breast cancer, ER positive breast cancer, PR positive breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- May 2004
- Study completion
- Oct 2007 (actual)
- First posted
- 7 Oct 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 progression free survival and efficacy of 250 mg ZD1839 in combination with a fixed dose of fulvestrant 250 mg im once a month will be evaluated in female patients with histologically-confirmed advanced or metastatic, ER and/or PR positive breast cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- 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 (9 listed)
- Histologically confirmed advanced or metastatic breast cancer
- postmenopausal females with amenorrhoea > 12 months and an intact uterus
- FSH levels within postmenopausal range or have undergone a bilateral oophorectomy
- ER \&/or PR positive
- previous adjuvant hormone therapy > 12 months prior to enrolment
Key exclusion criteria (15 listed)
- Male
- life-threatening metastatic visceral disease
- evidence of clinically active interstitial lung disease
- ER and PR negative
- treatment with LHRH analogues < 3 months prior to enrolment
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 and fulvestrant | Drug | – |
Primary outcome
To evaluate the progression-free survival (PFS) of the combination of 250 mg ZD1839 and fulvestrant in patients with advanced or metastatic breast cancer
4 secondary outcomes
To estimate the objective response rate (complete response [CR] and partial response [PR]) at trial closure.
To estimate the disease control rate at trial closure.
To estimate overall survival.
To evaluate the safety & tolerability of the combination gefitinib and fulvestrant
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 Spain Medical Director, MD study director
AstraZeneca
7 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 fulvestrant in people with Breast Cancer, run by AstraZeneca at 7 sites in Spain.
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 9 inclusion and 15 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 7 sites in Spain. 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 evaluate the progression-free survival (PFS) of the combination of 250 mg ZD1839 and fulvestrant in patients with advanced or metastatic breast cancer. 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.