Breast CancerPhase 2NCT00093002
Fulvestrant (FASLODEX™) as a Treatment in Postmenopausal Women With Estrogen Receptor Positive Breast Cancer
A Phase 2 study testing Fulvestrant in people with Breast Cancer, run by AstraZeneca at 31 sites in 6 countries.
Trial summary
The purpose of this study is to evaluate fulvestrant in the preliminary stage of breast cancer treatment and assess the relationship between dose, exposure, degree of reduction in tumor markers, and efficacy in postmenopausal women with estrogen receptor positive disease. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Fulvestrant
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 179 participants
- Where
- 31 sitesin 6 countries
- Study dates
- Jun 2004to Jul 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Postmenopausal women defined as women who have stopped having menstrual periods
- Written informed consent to participate in the trial
- Biopsy confirmation of invasive breast cancer
- Evidence of hormone sensitivity
- Willingness to undergo biopsies
Who cannot join
- Any previous treatment for breast cancer
- Unwillingness to stop taking any drug known to affect sex hormonal status or a patient in which it would be inappropriate to stop.
- Any severe concurrent condition that would preclude surgery or that would jeopardize compliance with the study, e.g., uncontrolled cardiac disease or uncontrolled diabetes mellitus
- The presence of more than one primary tumor
- History of hypersensitivity to castor oil
- History of known bleeding disorders
Trial locations and contacts
31 sites in 6 countries.
31 sites in 6 countries
United States7 sites
Research Site
Albuquerque, New Mexico
Research Site
Boston, Massachusetts
Research Site
Hershey, Pennsylvania
Research Site
Laredo, Texas
Research Site
Little Rock, Arkansas
Research Site
Nashville, Tennessee
Research Site
Winchester, Massachusetts
Brazil7 sites
Research Site
Barretos
Research Site
Florianópolis
Research Site
Goiamia
Research Site
Porto Alegre
Research Site
Rio de Janeiro
Research Site
Santo André
Research Site
São Paulo
Germany5 sites
Research Site
Berlin
Research Site
Hanover
Research Site
Magdeburg
Research Site
München
Research Site
Rostock
India5 sites
Research Site
Bangalore
Research Site
Hyderabaad
Research Site
New Delhi
Research Site
Pune
Research Site
Trivandrum
United Kingdom4 sites
Research Site
Birmingham
Research Site
Bournemouth
Research Site
Dundee
Research Site
Edinburgh
Austria3 sites
Research Site
Innsbruck
Research Site
Salzburg
Research Site
Vienna
About this study
Official title: A Randomized, Open-Label, Multicenter, Phase II Study Comparing the Effects on Proliferation and the Efficacy and Tolerability of Fulvestrant (FASLODEX®) 500 mg With Fulvestrant (FASLODEX®) 250 mg When Given as Neoadjuvant Treatment in Postmenopausal Women With Estrogen Receptor Positive Breast Cancer (T2, 3, 4b, N0-3, M0).
The purpose of this study is to evaluate fulvestrant in the preliminary stage of breast cancer treatment and assess the relationship between dose, exposure, degree of reduction in tumor markers, and efficacy in postmenopausal women with estrogen receptor positive disease.
- Conditions
- Breast Cancer
- Being tested
- Fulvestrant
- Keywords
- Early Breast Cancer, neoadjuvant therapy, hormonal treatment, newly diagnosed breast cancer, Estrogen Receptor Positive Breast Cancer, treatment naïve, neoadjuvant treatment, neoadjuvant setting, invasive 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.
FulvestrantDrug
Also called FASLODEX™, ZD9238
250 mg \& 500 mg intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 250 mg fulvestrant Receives: Drug: Fulvestrant |
| 2 | Experimental | 500 mg fulvestrant Receives: Drug: Fulvestrant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-proliferative effect after 4 weeks of treatment.
Secondary outcomes (1)
Safety, tolerability, tumor response and pharmacokinetics after 4 weeks of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2004 (estimated)
- Study startJun 2004
- Study completionJul 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- AstraZeneca Faslodex Medical Science Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00093002
- Sponsor's protocol ID
- 9238IL/0065
- Other IDs
- D6997C00003
- Status last verified
- Jun 2008
- First submitted
- 28 Sep 2004
- Last updated
- 12 Jun 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Multicenter, Phase II Study Comparing the Effects on Proliferation and the Efficacy and Tolerability of Fulvestrant (FASLODEX®) 500 mg With Fulvestrant (FASLODEX®) 250 mg When Given as Neoadjuvant Treatment in Postmenopausal Women With Estrogen Receptor Positive Breast Cancer (T2, 3, 4b, N0-3, M0).
- ClinicalTrials.gov ID
- NCT00093002
- Acronym / sponsor ID
- 9238IL/0065
- Conditions
- Breast Cancer
- Keywords
- Early Breast Cancer, neoadjuvant therapy, hormonal treatment, newly diagnosed breast cancer, Estrogen Receptor Positive Breast Cancer, treatment naïve, neoadjuvant treatment, neoadjuvant setting
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jun 2004
- Study completion
- Jul 2007 (actual)
- First posted
- 29 Sep 2004 (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 evaluate fulvestrant in the preliminary stage of breast cancer treatment and assess the relationship between dose, exposure, degree of reduction in tumor markers, and efficacy in postmenopausal women with estrogen receptor positive disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Fulvestrant250 mg fulvestrant |
| 2 | Experimental | Drug: Fulvestrant500 mg fulvestrant |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Postmenopausal women defined as women who have stopped having menstrual periods
- Written informed consent to participate in the trial
- Biopsy confirmation of invasive breast cancer
- Evidence of hormone sensitivity
- Willingness to undergo biopsies
Key exclusion criteria (6 listed)
- Any previous treatment for breast cancer
- Unwillingness to stop taking any drug known to affect sex hormonal status or a patient in which it would be inappropriate to stop.
- Any severe concurrent condition that would preclude surgery or that would jeopardize compliance with the study, e.g., uncontrolled cardiac disease or uncontrolled diabetes mellitus
- The presence of more than one primary tumor
- History of hypersensitivity to castor oil
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: FASLODEX™, ZD9238250 mg \& 500 mg intramuscular injection | Drug | 1, 2 |
Primary outcome
Anti-proliferative effect after 4 weeks of treatment.
1 secondary outcome
Safety, tolerability, tumor response and pharmacokinetics after 4 weeks of 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 12 Jun 2008.
- Medline Plus - Information on Breast CancerLink provided by the sponsor.
- Breastcancer.orgLink provided by the sponsor.
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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 Faslodex Medical Science Director, MD study director
AstraZeneca
31 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fulvestrant in people with Breast Cancer, run by AstraZeneca at 31 sites in 6 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 5 inclusion and 6 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 12 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States, Brazil, Germany, India, United Kingdom and 1 more country. 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?
Anti-proliferative effect after 4 weeks of treatment.. 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 12 Jun 2008.