Advanced Breast CancerPhase 2FINDER IINCT00313170
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 34 sites in 8 countries.
Trial summary
This study will assess the relationship between fulvestrant dose and efficacy in postmenopausal women with oestrogen receptor positive advanced breast cancer. Read more about this study
- Who is it for?
- Ages 45 to 130 years, 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
- 144 participants
- Where
- 34 sitesin 8 countries
- Study dates
- 30 May 2006to 13 Mar 2019
- 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 45 to 130 years
- Women only
- No healthy volunteers
- 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 (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 BC.
- Treatment with more than one previous regimen of endocrine therapy for advanced BC.
- An existing condition that prevents compliance.
Trial locations and contacts
34 sites in 8 countries.
34 sites in 8 countries
Canada10 sites
Research Site
Cambridge, Ontario, N1R 3G2
Research Site
Edmonton, Alberta, T6G 1Z2
Research Site
London, Ontario, N6A 4L6
Research Site
Montreal, Quebec, H3T 1E2
Research Site
Oshawa, Ontario, L1G 2B9
Research Site
Québec, Quebec, G1S 4L8
Research Site
Sault Ste. Marie, Ontario, P6A 2C4
Research Site
Toronto, Ontario, M4C 3E7
Research Site
Toronto, Ontario, M4N 3M5
Research Site
Vancouver, British Columbia, V5Z 4E6
Hungary5 sites
Research Site
Budapest, 1062
Research Site
Debrecen, 4032
Research Site
Győr, 9024
Research Site
Szeged, 6720
Research Site
Tatabánya, 2800
Poland5 sites
Research Site
Bydgoszcz, 85-796
Research Site
Gdansk, 80-214
Research Site
Gdansk, 80-462
Research Site
Krakow, 31-115
Research Site
Olsztyn, 10-228
Belgium4 sites
Research Site
Brussels, 1000
Research Site
Leuven, 3000
Research Site
Roeselare, 8800
Research Site
Wilrijk, 2610
France4 sites
Research Site
Bordeaux, 33000
Research Site
Brivé, 19312
Research Site
Clermont-Ferrand, 63011
Research Site
Poitiers, 86000
Czechia3 sites
Research Site
Cheb, 350 02
Research Site
Jičín, 506 43
Research Site
Prague, 140 00
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 in 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
intramuscular injection 250 mg \& 500 mg
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Fulvestrant 250 mg (intramuscular injection 250 mg) Receives: Drug: Fulvestrant |
| 2 | Experimental | Fulvestrant 250 mg (+ 250 mg loading regimen) Receives: Drug: Fulvestrant |
| 3 | Experimental | Fulvestrant 500 mg (intramuscular injection 500 mg) Receives: Drug: Fulvestrant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response (ORR)
Objective response rate was defined as percentage of patients with either complete response (CR - disappearance of all target lesions) or partial response (PR - at least 30% decrease in the sum of diameters of target lesions). All patients were to be followed up every 12 weeks for progression, defined by response evaluation criteria in solid tumors (RECIST v1.1).
Measured: The planned data cut-off for this study was when all patients, except withdrawals, had been followed up for at least 24 weeks. Patients received treatment up to approximately 2 years.
Secondary outcomes (5)
Time to Progression (TTP)
Time from randomisation until objective disease progression or death (in the absence of objective progression) using the Kaplan-Meier method. RECIST tumor assessments were carried out every 12 weeks until progression.
Measured: The planned data cut-off for this study was when all patients, except withdrawals, had been followed up for at least 24 weeks. Patients received treatment up to approximately 2 years.
Duration of Response (DoR)
DoR was defined as the time from date of first documentation of the response (CR or PR) until the date of disease progression or death from any cause.
Measured: The planned data cut-off for this study was when all patients, except withdrawals, had been followed up for at least 24 weeks. Patients received treatment up to approximately 2 years.
Clinical Benefit Rate (CBR)
CBR was defined as the proportion of all randomised patients who had clinical benefit (response of CR, PR or SD>=24 weeks.
Measured: The planned data cut-off for this study was when all patients, except withdrawals, had been followed up for at least 24 weeks. Patients received treatment up to approximately 2 years.
Pharmacokinetic Parameter: Mean Population Clearance, a Measure of the Efficiency With Which Fulvestrant is Eliminated From the Body
A 2-compartment model with a 1st order absorption and 1st order elimination process was fitted to the fulvestrant concentration-time data. Relative standard error is reported for the mean.
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
A 2-compartment model with a 1st order absorption and 1st order elimination process was fitted to the fulvestrant concentration-time data. Relative standard error is reported for the mean. The mean estimate of volume of distribution at steady state was reported as the sum of V1/F and V2/F in the clinical study report.
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 posted12 Apr 2006 (estimated)
- Study start30 May 2006
- Primary completion13 Jun 2008
- Study completion13 Mar 2019
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- AstraZeneca Breast Cancer Established Brands Team Medical Science Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00313170
- Sponsor's protocol ID
- D6997C00006
- Other IDs
- FINDER II
- Acronym
- FINDER II
- Status last verified
- Dec 2019
- First submitted
- 10 Apr 2006
- Last updated
- 6 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Pritchard KI, Rolski J, Papai Z, Mauriac L, Cardoso F, Chang J, Panasci L, Ianuli C, Kahan Z, Fukase K, Lindemann JP, Macpherson MP, Neven P. Results of a phase II study comparing three dosing regimens of fulvestrant in postmenopausal women with advanced breast cancer (FINDER2). Breast Cancer Res Treat. 2010 Sep;123(2):453-61. doi: 10.1007/s10549-010-1022-9. Epub 2010 Jul 15.
PubMed 20632084
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2020. 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
- NCT00313170
- Acronym / sponsor ID
- FINDER II / D6997C00006
- Conditions
- Advanced Breast Cancer, Metastatic Breast Cancer
- Keywords
- oncology, cancer, breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 30 May 2006 (actual)
- Primary completion
- 13 Jun 2008 (actual)
- Study completion
- 13 Mar 2019 (actual)
- First posted
- 12 Apr 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 in 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 250 mg) |
| 2 | Experimental | Drug: FulvestrantFulvestrant 250 mg (+ 250 mg loading regimen) |
| 3 | Experimental | Drug: FulvestrantFulvestrant 500 mg (intramuscular injection 500 mg) |
Who may qualify
- Ages
- 45 to 130 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- 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 (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 BC.
- Treatment with more than one previous regimen of endocrine therapy for advanced BC.
- An existing condition that prevents compliance.
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, ZD9238intramuscular injection 250 mg \& 500 mg | Drug | 1, 2, 3 |
Primary outcome
Objective Response (ORR)
Time frame: The planned data cut-off for this study was when all patients, except withdrawals, had been followed up for at least 24 weeks. Patients received treatment up to approximately 2 years.
Objective response rate was defined as percentage of patients with either complete response (CR - disappearance of all target lesions) or partial response (PR - at least 30% decrease in the sum of diameters of target lesions). All patients were to be followed up every 12 weeks for progression, defined by response evaluation criteria in solid tumors (RECIST v1.1).
5 secondary outcomes
Time to Progression (TTP)
Time frame: The planned data cut-off for this study was when all patients, except withdrawals, had been followed up for at least 24 weeks. Patients received treatment up to approximately 2 years.
Duration of Response (DoR)
Time frame: The planned data cut-off for this study was when all patients, except withdrawals, had been followed up for at least 24 weeks. Patients received treatment up to approximately 2 years.
Clinical Benefit Rate (CBR)
Time frame: The planned data cut-off for this study was when all patients, except withdrawals, had been followed up for at least 24 weeks. Patients received treatment up to approximately 2 years.
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 6 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 20632084Pritchard KI, Rolski J, Papai Z, Mauriac L, Cardoso F, Chang J, Panasci L, Ianuli C, Kahan Z, Fukase K, Lindemann JP, Macpherson MP, Neven P. Results of a phase II study comparing three dosing regimens of fulvestrant in postmenopausal women with advanced breast cancer (FINDER2). Breast Cancer Res Treat. 2010 Sep;123(2):453-61. doi: 10.1007/s10549-010-1022-9. Epub 2010 Jul 15.
- Related InfoLink provided by the sponsor.
- CSR-D6997C00006.pdfLink 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 Breast Cancer Established Brands Team Medical Science Director, MD study director
AstraZeneca
34 sites in 8 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 Advanced Breast Cancer and Metastatic Breast Cancer, run by AstraZeneca at 34 sites in 8 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 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 6 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in Canada, Hungary, Poland, Belgium, France and 3 more countries. 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 (ORR) (time frame: The planned data cut-off for this study was when all patients, except withdrawals, had been followed up for at least 24 weeks. Patients received treatment up to approximately 2 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00313170, which also lists 1 linked publication.
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 6 Jan 2020.