Advanced Breast CancerPhase 3NCT00635713
Second Line Breast Cancer Trial
A Phase 3 study testing Fulvestrant and Anastrozole in people with Advanced Breast Cancer, run by AstraZeneca.
Trial summary
The main purpose of this study is to compare the effect of 2 doses of FASLODEX with 1 dose of ARIMIDEX in terms of time to tumor progression in postmenopausal women with advanced breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Advanced Breast Cancer
- What is being tested?
- Fulvestrant and Anastrozole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 588 participants
- Where
- No sites listed yet
- Study dates
- May 1997to Sep 2004
- Phase
- Phase 3
- 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
- postmenopausal women with confirmation of breast cancer
- objective evidence of recurrence or progression of breast cancer no more than 1 prior hormonal therapy for breast cancer
Who cannot join
- presence of life-threatening metastatic visceral disease
- previous treatment with FASLODEX, ARIMIDEX or any aromatase inhibitor for breast cancer
- more than 1 prior endocrine medical treatment for advanced breast cancer .
About this study
Official title: A Double-Blind, Randomized, Multi-Center Trial Comparing the Efficacy and Tolerability of 125 and 250mg of Faslodex (Long Acting ICI 182,780) With 1mg Arimidex (Anastrazole) in Postmenopausal Women With Advanced Breast Cancer.
The main purpose of this study is to compare the effect of 2 doses of FASLODEX with 1 dose of ARIMIDEX in terms of time to tumor progression in postmenopausal women with advanced breast cancer.
- Conditions
- Advanced Breast Cancer
- Being tested
- Fulvestrant, Anastrozole
- Keywords
- Advanced breast cancer, FASLODEX, ARIMIDEX, Fulvestrant, Anastrozole, postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FulvestrantDrug
Also called Faslodex
125mg
AnastrozoleDrug
ARIMIDEX
FulvestrantDrug
Also called Faslodex
250mg
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Faslodex 125mg and Arimidex 1 mg Receives: Drug: Fulvestrant; Drug: Anastrozole |
| 2 | Experimental | Faslodex 250mg and Arimidex 1mg Receives: Drug: Anastrozole; Drug: Fulvestrant |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to tumor progression
Measured: Every 3 months
Secondary outcomes (3)
objective tumor response
Measured: Every 3 months
time to treatment failure
Measured: Every 3 months
time to death
Measured: Every 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2008 (estimated)
- Study startMay 1997
- Study completionSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 588 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Guido Hoctin-Boes, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00635713
- Sponsor's protocol ID
- 9238IL/0021
- Other IDs
- D6995C00021
- Status last verified
- Apr 2009
- First submitted
- 7 Mar 2008
- Last updated
- 10 Apr 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Multi-Center Trial Comparing the Efficacy and Tolerability of 125 and 250mg of Faslodex (Long Acting ICI 182,780) With 1mg Arimidex (Anastrazole) in Postmenopausal Women With Advanced Breast Cancer.
- ClinicalTrials.gov ID
- NCT00635713
- Acronym / sponsor ID
- 9238IL/0021
- Conditions
- Advanced Breast Cancer
- Keywords
- Advanced breast cancer, FASLODEX, ARIMIDEX, Fulvestrant, Anastrozole, postmenopausal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 588 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- May 1997
- Study completion
- Sep 2004 (actual)
- First posted
- 14 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.
The main purpose of this study is to compare the effect of 2 doses of FASLODEX with 1 dose of ARIMIDEX in terms of time to tumor progression in postmenopausal women with advanced breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Fulvestrant, Drug: AnastrozoleFaslodex 125mg and Arimidex 1 mg |
| 2 | Experimental | Drug: Anastrozole, Drug: FulvestrantFaslodex 250mg and Arimidex 1mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- postmenopausal women with confirmation of breast cancer
- objective evidence of recurrence or progression of breast cancer no more than 1 prior hormonal therapy for breast cancer
Key exclusion criteria (3 listed)
- presence of life-threatening metastatic visceral disease
- previous treatment with FASLODEX, ARIMIDEX or any aromatase inhibitor for breast cancer
- more than 1 prior endocrine medical treatment for advanced breast 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 |
|---|---|---|
| FulvestrantAlso: Faslodex125mg | Drug | 1 |
| AnastrozoleARIMIDEX | Drug | 1, 2 |
| FulvestrantAlso: Faslodex250mg | Drug | 2 |
Primary outcome
time to tumor progression
Time frame: Every 3 months
3 secondary outcomes
objective tumor response
Time frame: Every 3 months
time to treatment failure
Time frame: Every 3 months
time to death
Time frame: Every 3 months
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 10 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.
Guido Hoctin-Boes study director
AstraZeneca
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fulvestrant and Anastrozole in people with Advanced 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 2 inclusion and 3 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 10 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
time to tumor progression (time frame: Every 3 months). 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 10 Apr 2009.