Advanced Breast CancerPhase 2FINDER INCT00305448
A Clinical Trial to Compare Efficacy and Tolerability of Fulvestrant 250mg, 250mg (Plus 250mg Loading Regimen) and 500mg
A Phase 2 study testing Fulvestrant in people with Advanced Breast Cancer and Metastatic Breast Cancer, run by AstraZeneca at 35 sites in Japan.
Trial summary
This study will assess the relationship between fulvestrant dose and efficacy, and determine the dosing regimen as a second line therapy for Japanese postmenopausal women with oestrogen receptor positive advanced breast cancer. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Advanced Breast Cancer, Metastatic 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
- 143 participants
- Where
- 35 sitesJapan
- Study dates
- Mar 2006to Feb 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Breast Cancer has continued to grow after having received treatment with an anti-estrogen hormonal treatment such as tamoxifen or an aromatase inhibitor
- Requiring hormonal treatment
- Postmenopausal women defined as a woman who has stopped having menstrual periods
Who cannot join
- Treatment with more than one previous regimen of systemic anticancer therapy other than endocrine therapy for advanced breast cancer
- Treatment with more than one previous regimen of endocrine therapy for advanced breast cancer
- An existing serious disease, illness, or condition that will prevent participation or compliance with study procedures
Trial locations and contacts
35 sites in 1 country.
35 sites in 1 country
Japan35 sites
Research Site
Amagasaki, Hyōgo
Research Site
Asahi, Chiba
Research Site
Chiba, Chiba
Research Site
Chūō, Tokyo
Research Site
Daito, Fukushima
Research Site
Fukuoka, Fukuoka
Research Site
Fukuyama, Hiroshima
Research Site
Hiroshima, Hiroshima
Research Site
Isehara, Kanagawa
Research Site
Izumisano, Osaka
Research Site
Kawasaki
Research Site
Kitakyushu, Fukuoka
Research Site
Kōriyama, Fukushima
Research Site
Koto-ku, Tokyo
Research Site
Kumamoto, Kumamoto
Research Site
Kurashiki, Okayama-ken
Research Site
Kure, Hiroshima
Research Site
Kurume, Fukuoka
Research Site
Matsubaracho, Kagoshima-ken
Research Site
Matsuyama, Ehime
Research Site
Morohongō, Saitama
Research Site
Nagoya, Aichi-ken
Research Site
Niigata, Niigata
Research Site
Ōita, Oita Prefecture
Research Site
Osaka, Osaka
Research Site
Ōta, Gunma
Research Site
Sagamihara, Kanagawa
Research Site
Sakai, Osaka
Research Site
Sapporo, Hokkaido
Research Site
Sendai, Miyagi
Research Site
Shimotsuke, Tochigi
Research Site
Shinden, Saitama
Research Site
Shizuoka, Shizuoka
Research Site
Suita, Osaka
Research Site
Yokohama, Kanagawa
About this study
Official title: Phase II Study to Evaluate the Efficacy and Tolerability of Fulvestrant 250mg, 250mg (Plus 250mg Loading Regimen) and 500mg in Postmenopausal Women With ER +ve Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy
This study will assess the relationship between fulvestrant dose and efficacy, and determine the dosing regimen as a second line therapy for Japanese postmenopausal women with oestrogen receptor positive advanced breast cancer.
- Conditions
- Advanced Breast Cancer, Metastatic Breast Cancer
- Being tested
- Fulvestrant
- Keywords
- oncology, cancer, breast cancer
- Medical subject headings
- Breast Neoplasms, 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 intramuscular injection
FulvestrantDrug
500 mg intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Fulvestrant 250 mg intramuscular injection Receives: Drug: Fulvestrant |
| 2 | Experimental | Fulvestrant 250mg (Plus 250mg Loading Regimen) Receives: Drug: Fulvestrant |
| 3 | Experimental | Fulvestrant 500 mg Receives: Drug: Fulvestrant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
An objective response (OR) is defined as a patient having a best overall response of either complete response (CR) or partial response (PR). A patient has best overall response of CR if she had overall response of CR or PR on one visit and met the confirmation criteria per RECIST. ORR is defined as percentage of patients with objective response.
Each patient with measurable disease at baseline was assessed for OR from the sequence of Response Evaluation Criteria in Solid Tumors (RECIST) scan data up to data cut-off. RECIST scans were performed every 12 weeks (+/- 2weeks) from randomization
Measured: baseline and every 12 weeks (+/- 2weeks) from randomization data up to data cut-off (19th march 2008)
Secondary outcomes (5)
Time to Progression (TTP)
Time (in days) from randomization until objective disease progression or death (in the absence of objective progression). RECIST tumour assessments carried out every 12 weeks from randomization (+/- 2 weeks) until data cut-off on 19th March 2008.
Measured: every 12 weeks from randomization (+/- 2 weeks) until data cut-off (19th march 2008)
Duration of Response (DoR)
Time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who achieved a confirmed Complete Response or confirmed Partial Response.
Measured: RECIST tumour assessments carried out every 12 weeks from randomisation (+/- 2 weeks) until data cut-off on19th March 2008.
Clinical Benefit Rate (CBR)
A Clinical Benefit (CB) responder is defined as a patient having a best overall response of Complete response (CR), Partial Response (PR) or Stable disease (SD) provided SD (or better) was present = 154 days from randomization (ie SD = 24 weeks with the 2 week RECIST assessment time window allowed). The Clinical Benefit Rate is the percentage of patients with CB.
Measured: every 12 weeks(+/- 2 weeks) from randomization to data up to data cut-off, 19th March 2008.
Pharmacokinetic Parameter: Mean Population Clearance, a Measure of the Efficiency With Which Fulvestrant is Eliminated From the Body
The measure of dispersion for mean population clearance is based on the estimated inter-individual variance
Measured: Baseline to 12 weeks
Pharmacokinetic Parameter: Mean Volume of Distribution at Steady State, a Measure of the Apparent Volume in the Body Into Which Fulvestrant Distributes
The measure of dispersion for volume of distribution is based on the inter-individual variance estimated for the apparent volume of plasma into which Fulvestrant distributes
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2006 (estimated)
- Study startMar 2006
- Primary completionMar 2008
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- AstraZeneca Japan Medical Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00305448
- Sponsor's protocol ID
- D6997C00004
- Other IDs
- FINDER I
- Acronym
- FINDER I
- Status last verified
- Feb 2012
- First submitted
- 20 Mar 2006
- Last updated
- 15 Feb 2012
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study to Evaluate the Efficacy and Tolerability of Fulvestrant 250mg, 250mg (Plus 250mg Loading Regimen) and 500mg in Postmenopausal Women With ER +ve Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy
- ClinicalTrials.gov ID
- NCT00305448
- Acronym / sponsor ID
- FINDER I / D6997C00004
- Conditions
- Advanced Breast Cancer, Metastatic Breast Cancer
- Keywords
- oncology, cancer, breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- Mar 2008 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 22 Mar 2006 (estimated)
- Results
- Posted 29 Aug 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the relationship between fulvestrant dose and efficacy, and determine the dosing regimen as a second line therapy for Japanese postmenopausal women with oestrogen receptor positive advanced breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: FulvestrantFulvestrant 250 mg intramuscular injection |
| 2 | Experimental | Drug: FulvestrantFulvestrant 250mg (Plus 250mg Loading Regimen) |
| 3 | Experimental | Drug: FulvestrantFulvestrant 500 mg |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Breast Cancer has continued to grow after having received treatment with an anti-estrogen hormonal treatment such as tamoxifen or an aromatase inhibitor
- Requiring hormonal treatment
- Postmenopausal women defined as a woman who has stopped having menstrual periods
Key exclusion criteria (3 listed)
- Treatment with more than one previous regimen of systemic anticancer therapy other than endocrine therapy for advanced breast cancer
- Treatment with more than one previous regimen of endocrine therapy for advanced breast cancer
- An existing serious disease, illness, or condition that will prevent participation or compliance with study procedures
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 intramuscular injection | Drug | 1, 2 |
| Fulvestrant500 mg intramuscular injection | Drug | 3 |
Primary outcome
Objective Response Rate (ORR)
Time frame: baseline and every 12 weeks (+/- 2weeks) from randomization data up to data cut-off (19th march 2008)
An objective response (OR) is defined as a patient having a best overall response of either complete response (CR) or partial response (PR). A patient has best overall response of CR if she had overall response of CR or PR on one visit and met the confirmation criteria per RECIST. ORR is defined as percentage of patients with objective response. Each patient with measurable disease at baseline was assessed for OR from the sequence of Response Evaluation Criteria in Solid Tumors (RECIST) scan data up to data cut-off. RECIST scans were performed every 12 weeks (+/- 2weeks) from randomization
5 secondary outcomes
Time to Progression (TTP)
Time frame: every 12 weeks from randomization (+/- 2 weeks) until data cut-off (19th march 2008)
Duration of Response (DoR)
Time frame: RECIST tumour assessments carried out every 12 weeks from randomisation (+/- 2 weeks) until data cut-off on19th March 2008.
Clinical Benefit Rate (CBR)
Time frame: every 12 weeks(+/- 2 weeks) from randomization to data up to data cut-off, 19th March 2008.
Pharmacokinetic Parameter: Mean Population Clearance, a Measure of the Efficiency With Which Fulvestrant is Eliminated From the Body
Time frame: Baseline to 12 weeks
Pharmacokinetic Parameter: Mean Volume of Distribution at Steady State, a Measure of the Apparent Volume in the Body Into Which Fulvestrant Distributes
Time frame: Baseline to 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 Japan Medical Director, MD study director
AstraZeneca
35 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 Fulvestrant in people with Advanced Breast Cancer and Metastatic Breast Cancer, run by AstraZeneca at 35 sites in Japan.
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 3 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 15 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in Japan. 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?
Yes. Results are posted in the registry (first posted 29 Aug 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Objective Response Rate (ORR) (time frame: baseline and every 12 weeks (+/- 2weeks) from randomization data up to data cut-off (19th march 2008)). 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 15 Feb 2012.