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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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.

Country

City, postcode or hospital

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

Other trials in Germany

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

Other trials in Sweden

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

Other trials in France

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

Other trials in Italy

Norway7 sites

Research Site
Drammen
Research Site
Ilesund
Research Site
Oslo
Research Site
Porsgrunn
Research Site
Stavanger
Research Site
Troms
Research Site
Trondheim

Other trials in Norway

Canada5 sites

Research Site
Brampton
Research Site
Halifax
Research Site
Kingston
Research Site
Ontario
Research Site
Toronto

Other trials in Canada

Portugal4 sites

Research Site
Cascais
Research Site
Coimbra
Research Site
Lisbon
Research Site
Santa Maria da Feira

Other trials in Portugal

Turkey (Türkiye)4 sites

Research Site
Ankara
Research Site
Edirne
Research Site
Gaziantep
Research Site
Istanbul

Other trials in Turkey (Türkiye)

Finland2 sites

Research Site
Hämeenlinna
Research Site
Turku

Other trials in Finland

Costa Rica1 site

Research Site
San José

Other trials in Costa Rica

Guatemala1 site

Research Site
Guatemala City

Other trials in Guatemala

Iceland1 site

Research Site
Reykjavik

Other trials in Iceland

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.

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 groups in NCT00256698
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.

Jan 2004Feb 2012

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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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.

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

Results posted to the registry on 9 Feb 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Fulvestrant + Anastrozole	258	91
Anastrozole	256	84

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. Median (Full Range). Unit: months

Measure	Fulvestrant + Anastrozole n = 258	Anastrozole n = 256
Value	10.8 (0 to 49.31)	10.2 (0 to 54.34)

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fulvestrant + Anastrozole	40 of 256 (15.6%)	161 of 256 (62.9%)	Not reported
Anastrozole	45 of 254 (17.7%)	178 of 254 (70.1%)	Not reported

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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Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
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Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
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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?

On the ClinicalTrials.gov record for NCT00256698.

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.