Breast CancerPhase 3FACTNCT00256698
Anastrozole Monotherapy Versus Maximal Oestrogen Blockade With Anastrozole and Fulvestrant Combination Therapy
A Phase 3 study testing Fulvestrant and Anastrozole in people with Breast Cancer, run by AstraZeneca at 85 sites in 12 countries.
Trial summary
The purpose of this study is to determine the efficacy of anastrozole monotherapy versus maximal oestrogen blockade with combinated therapy of fulvestrant and anastrozole compared with in treatment of hormone receptor positive women with first relapse of breast cancer. 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 and Anastrozole
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 514 participants
- Where
- 85 sitesin 12 countries
- Study dates
- Jan 2004to Feb 2012
- Phase
- Phase 3
- 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
- Signed informed consent, postmenopausal females, histological or cytological confirmed oestrogene and/or progesterone (PgR) receptor positive breast cancer, local recurrence or metastasis
Who cannot join
- Previous systemic endocrine therapy for advanced or recurrent disease; prior fulvestrant therapy
- Premenopausal women
Trial locations and contacts
85 sites in 12 countries.
85 sites in 12 countries
Germany24 sites
Research Site
Augsburg
Research Site
Cologne
Research Site
Düsseldorf
Research Site
Erlangen
Research Site
Frankfurt
Research Site
Gifhorn
Research Site
Großhadern
Research Site
Halle
Research Site
Hamburg
Research Site
Hanover
Research Site
Heidelberg
Research Site
Ingolstadt
Research Site
Kassel
Research Site
Kiel
Research Site
Leipzig
Research Site
Leverkusen
Research Site
Magdeburg
Research Site
Mannheim
Research Site
Marburg
Research Site
München
Research Site
Rostock
Research Site
Trier
Research Site
Ulm
Research Site
Ziwicken
Sweden18 sites
Research Site
Halmstad
Research Site
Helsingborg
Research Site
Kalmar
Research Site
Karlskrona
Research Site
Kristianstad
Research Site
Link'ping
Research Site
M'lndal
Research Site
Malm
Research Site
Norrk'ping
Research Site
Skellefteå
Research Site
Skövde
Research Site
Södra Sunderbyn
Research Site
Stockholm
Research Site
Sundsvall
Research Site
Umeå
Research Site
V'rnamo
Research Site
V'stervik
Research Site
Varberg
France9 sites
Research Site
Avignon
Research Site
Caen
Research Site
Créteil
Research Site
Grenoble
Research Site
La Chaussée-Saint-Victor
Research Site
Périgueux
Research Site
Perpignan
Research Site
Saint Cyr Sur Louire
Research Site
Toulouse
Italy9 sites
Research Site
Como
Research Site
Fabriano
Research Site
Ferrara
Research Site
Florence
Research Site
Lugo
Research Site
Milan
Research Site
Taormina
Research Site
Treviglio
Research Site
Vicenza
Norway7 sites
Research Site
Drammen
Research Site
Ilesund
Research Site
Oslo
Research Site
Porsgrunn
Research Site
Stavanger
Research Site
Troms
Research Site
Trondheim
Canada5 sites
Research Site
Brampton
Research Site
Halifax
Research Site
Kingston
Research Site
Ontario
Research Site
Toronto
Portugal4 sites
Research Site
Cascais
Research Site
Coimbra
Research Site
Lisbon
Research Site
Santa Maria da Feira
Turkey (Türkiye)4 sites
Research Site
Ankara
Research Site
Edirne
Research Site
Gaziantep
Research Site
Istanbul
About this study
Official title: FACT: Anastrozole Monotherapy Versus Maximal Oestrogen Blockade With Anastrozole and Fulvestrant Combination Therapy; an Open Randomized, Comparative, Phase III Multicentre Study in Postmenopausal Women With Hormone Receptor Positive Breast Cancer in First Relapse After Primary Treatment of Localized Tumor.
The purpose of this study is to determine the efficacy of anastrozole monotherapy versus maximal oestrogen blockade with combinated therapy of fulvestrant and anastrozole compared with in treatment of hormone receptor positive women with first relapse of breast cancer.
- Conditions
- Breast Cancer
- Being tested
- Fulvestrant, Anastrozole
- Keywords
- Hormone, receptor, positive, breast, cancer, first, relapse
- Medical subject headings
- Breast Neoplasms, Neoplasms, Recurrence
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 loading dose (LD) regimen
AnastrozoleDrug
Also called Arimidex, ZD1033
1 mg oral tablet
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Anastrozole Receives: Drug: Anastrozole |
| 2 | Experimental | Anastrozole + Fulvestrant Receives: Drug: Fulvestrant; Drug: Anastrozole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Progression (TTP)
RECIST (Response Evaluation Criteria in Solid Tumours) assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009. TTP, time in months to worsen 'progression' according to RECIST criteria. (RECIST is a set of published rules that define when cancer patients improve "respond", stay the same "stable"or worsen "progression" during treatments.
Measured: RECIST assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009
Secondary outcomes (6)
Percentage of Evaluable Participants With Objective Response Rate (ORR)
No. of patients who were objective responders over the no. of patients evaluable for response x100. An objective responder = a patient whose best response is either CR (disappearance of all lesions) or PR (>= 30% shrinkage in the sum of the longest diamemeters of the measurable lesions + no new lesions + no progression of non-measurable lesions)
Measured: RECIST tumour assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009
Percentage of Clinical Benefit Rate (CBR) Responders
No. of patients who were clinical benefit responders over the no. of randomised patients x100. A clinical benefit responder = a patient whose best response is CR, PR or SD>=24 weeks (where a best response of SD = no new lesions and for existing lesions; neither suffient shrinkage to count as PR nor sufficient growth to count as progression)
Measured: RECIST tumour assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009
Duration of Response (DoR)
Median time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who are objective responders
Measured: RECIST tumour assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009
Duration of Clinical Benefit (DoCB)
Median time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who are clinical benefit responders
Measured: RECIST tumour assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009
Time to Treatment Failure (TTF)
Time from randomisation until the date of discontinuation of randomised treatment for any reason
Measured: From randomisation until data cut-off on 30th April 2009
Overall Survival (OS)
Overall survival is equivalent to time to death. Time from randomisation until the date of death
Measured: All deaths occurring between randomisation and data cut-off on 30th April 2009 are included.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2005 (estimated)
- Study startJan 2004
- Primary completionApr 2009
- 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 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
- None (open label)
- Enrolment
- 514 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roger Henriksson, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00256698
- Sponsor's protocol ID
- D6997L00002
- Other IDs
- 9238SW/0001, FACT
- Acronym
- FACT
- Status last verified
- Jul 2012
- First submitted
- 20 Nov 2005
- Last updated
- 1 Aug 2012
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FACT: Anastrozole Monotherapy Versus Maximal Oestrogen Blockade With Anastrozole and Fulvestrant Combination Therapy; an Open Randomized, Comparative, Phase III Multicentre Study in Postmenopausal Women With Hormone Receptor Positive Breast Cancer in First Relapse After Primary Treatment of Localized Tumor.
- ClinicalTrials.gov ID
- NCT00256698
- Acronym / sponsor ID
- FACT / D6997L00002
- Conditions
- Breast Cancer
- Keywords
- Hormone, receptor, positive, breast, cancer, first, relapse
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 514 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jan 2004
- Primary completion
- Apr 2009 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 22 Nov 2005 (estimated)
- Results
- Posted 9 Feb 2011
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 determine the efficacy of anastrozole monotherapy versus maximal oestrogen blockade with combinated therapy of fulvestrant and anastrozole compared with in treatment of hormone receptor positive women with first relapse of breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: AnastrozoleAnastrozole |
| 2 | Experimental | Drug: Fulvestrant, Drug: AnastrozoleAnastrozole + Fulvestrant |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Signed informed consent, postmenopausal females, histological or cytological confirmed oestrogene and/or progesterone (PgR) receptor positive breast cancer, local recurrence or metastasis
Key exclusion criteria (2 listed)
- Previous systemic endocrine therapy for advanced or recurrent disease; prior fulvestrant therapy
- Premenopausal women
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 loading dose (LD) regimen | Drug | 2 |
| AnastrozoleAlso: Arimidex, ZD10331 mg oral tablet | Drug | 1, 2 |
Primary outcome
Time to Progression (TTP)
Time frame: RECIST assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009
RECIST (Response Evaluation Criteria in Solid Tumours) assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009. TTP, time in months to worsen 'progression' according to RECIST criteria. (RECIST is a set of published rules that define when cancer patients improve "respond", stay the same "stable"or worsen "progression" during treatments.
6 secondary outcomes
Percentage of Evaluable Participants With Objective Response Rate (ORR)
Time frame: RECIST tumour assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009
Percentage of Clinical Benefit Rate (CBR) Responders
Time frame: RECIST tumour assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009
Duration of Response (DoR)
Time frame: RECIST tumour assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009
Duration of Clinical Benefit (DoCB)
Time frame: RECIST tumour assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009
Time to Treatment Failure (TTF)
Time frame: From randomisation until data cut-off on 30th April 2009
Overall Survival (OS)
Time frame: All deaths occurring between randomisation and data cut-off on 30th April 2009 are included.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 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.
Roger Henriksson, MD study director
AstraZeneca
85 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fulvestrant and Anastrozole in people with Breast Cancer, run by AstraZeneca at 85 sites in 12 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 1 inclusion and 2 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 1 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 85 sites in Germany, Sweden, France, Italy, Norway and 7 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 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?
Yes. Results are posted in the registry (first posted 9 Feb 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?
Time to Progression (TTP) (time frame: RECIST assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009). 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 1 Aug 2012.