Metastatic Breast CancerPhase 2FIRSTNCT00274469

A Clinical Trial to Compare Efficacy and Tolerability of Faslodex With Arimidex in Patients With Advanced Breast Cancer

A Phase 2 study testing fulvestrant and anastrozole in people with Metastatic Breast Cancer, run by AstraZeneca at 41 sites in 9 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 compare the efficacy and tolerability of Faslodex (fulvestrant) with Arimidex (anastrozole) in postmenopausal women with hormone receptor positive advanced breast cancer. Read more about this study

Who is it for?: Ages 45 to 100 years, women only
Conditions the study is for: Metastatic 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: 205 participants
Where: 41 sitesin 9 countries
Study dates: 6 Feb 2006to 13 Jan 2017
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 100 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Confirmed hormone receptor positive advanced breast cancer, postmenopausal women

Who cannot join

Previous treatment for advanced breast cancer (previous treatment for early breast cancer is allowed).

Trial locations and contacts

41 sites in 9 countries.

Country

City, postcode or hospital

41 sites in 9 countries

Bulgaria9 sites

Research Site
Blagoevgrad, 2700
Research Site
Plovdiv, 4000
Research Site
Shumen, 9700
Research Site
Sofia, 1233
Research Site
Sofia, 1527
Research Site
Sofia, 1784
Research Site
Varna, 9000
Research Site
Veliko Tarnovo, 5000
Research Site
Vratsa, 3000

Other trials in Bulgaria

Brazil6 sites

Research Site
Barretos, 14784-400
Research Site
Belo Horizonte, 30380-490
Research Site
Goiânia, 74000-000
Research Site
Jaú, 17210-120
Research Site
Rio de Janeiro, 20560-120
Research Site
São Paulo, 01219-010

Other trials in Brazil

Czechia6 sites

Research Site
Brno, 656 53
Research Site
Brno, 656 91
Research Site
Jičín, 506 43
Research Site
Ostrava, 708 52
Research Site
Prague, 140 00
Research Site
Ústí nad Labem, 401 13

Other trials in Czechia

United States5 sites

Research Site
Austin, Texas, 78705
Research Site
Duncanville, Texas, 75137
Research Site
Frederick, Maryland, 21701
Research Site
St Louis, Missouri, 63113
Research Site
Teaneck, New Jersey, 07666

Other trials in United States

Spain5 sites

Research Site
Barcelona, 08003
Research Site
Barcelona, 08025
Research Site
Córdoba, 14004
Research Site
Lleida, 25198
Research Site
Pontevedra, 36002

Other trials in Spain

France3 sites

Research Site
Nice, 06100
Research Site
Poitiers, 86000
Research Site
Saint-Cloud, 92210

Other trials in France

United Kingdom3 sites

Research Site
Derby, DE22 3DT
Research Site
Dundee, DD1 9SY
Research Site
Edinburgh, EH4 2XU

Other trials in United Kingdom

Italy2 sites

Research Site
Naples, 80131
Research Site
Sassari, 07100

Other trials in Italy

Poland2 sites

Research Site
Krakow, 31-115
Research Site
Olsztyn, 10-228

Other trials in Poland

About this study

Official title: A Randomized, Open-Label, Parallel-Group, Multicentre, Phase II Study to Compare the Efficacy and Tolerability of Fulvestrant (FASLODEX™) 500 mg With Anastrozole (ARIMIDEX™) 1 mg as First Line Hormonal Treatment for Postmenopausal Women With Hormone Receptor Positive Advanced Breast Cancer

Conditions: Metastatic Breast Cancer
Being tested: fulvestrant, anastrozole
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
500 mg intramuscular injection
anastrozoleDrug
Also called Arimidex, ZD1033
1 mg oral tablet

Study groups in NCT00274469
Study group	Role	What they receive
1	Experimental	Fulvestrant Receives: Drug: fulvestrant
2	Active comparator	Anastrozole Receives: Drug: anastrozole

What is being measured

The primary outcome is the main question the study is designed to answer.

Clinical Benefit Rate
A Clinical Benefit (CB) responder is defined as a patient having a best overall response of either complete response (CR), partial response (PR) or stable disease (SD) for at least 24 weeks evaluated according to modified RECIST. The Clinical Benefit Rate is the percentage of patients with CB.
Measured: From randomisation to data cut off (DCO) for primary analysis. The first and the last patients were enrolled on 6 Feb 2006 and 11 Jul 2007 respectively. The DCO for primary analysis was on 10th Jan 2008, 6 months after the last patient was enrolled.

Secondary outcomes (4)

Objective Response Rate
For each patient with measurable disease at baseline, the determination of the overall response for each visit was carried out using a SAS program per Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete Response (CR): Disappearance of all target lesion (TL) and non-target lesions (NTLs) and no new lesions. Partial Response (PR): At least a 30% decrease in the sum of longest diameter of TLs (compared to baseline), no progression of NTLs and no new lesions. Objective response rate is defined as percentage of patients with either CR or PR.
Measured: From randomisation to data cut off (DCO) for primary analysis. The first and the last patients were enrolled on 6 Feb 2006 and 11 Jul 2007 respectively. The DCO for primary analysis was on 10th Jan 2008, 6 months after the last patient was enrolled.
Time to Progression
Time from randomization until earlier of disease progression or death. Progression was defined according to RECIST: a patient is determined to have progressed if they have progression of target lesions, clear progression of existing non-target lesions, or the appearance of one or more new lesions. Progression of target lesions is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum of LD recorded. Kaplan-Meier estimates of median for each treatment are reported.
Measured: From randomisation to data cut off (DCO) for primary analysis. The first and the last patients were enrolled on 6 Feb 2006 and 11 Jul 2007 respectively. The DCO for primary analysis was on 10th Jan 2008, 6 months after the last patient was enrolled.
Time to Treatment Failure
Time from randomization to treatment discontinuation
Measured: From randomisation to data cut off (DCO) for 75% treatment failure. The first and the last patients were enrolled on 6 Feb 2006 and 11 Jul 2007. The DCO for 75% treatment failure was on 26 Mar 2010, 32 months after the last patient was enrolled.
Time to Progression (Investigator Assessed)
Time from randomization to disease progression (investigator assessed) or death from any cause. Progression was defined by investigator opinion, as patients did not have formal RECIST visits in the follow-up period after the data cut off for the primary analysis of the study.
Measured: From randomisation to data cut off (DCO) for 75% treatment failure. The first and the last patients were enrolled on 6 Feb 2006 and 11 Jul 2007. The DCO for 75% treatment failure was on 26 Mar 2010, 32 months after the last patient was enrolled.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Feb 200613 Jan 2017

First posted11 Jan 2006 (estimated)
Study start6 Feb 2006
Primary completion10 Jan 2008
Study completion13 Jan 2017

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 Metastatic 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: 205 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00274469
Sponsor's protocol ID: D6995C00006
Other IDs: FIRST
Acronym: FIRST
Status last verified: Aug 2019
First submitted: 10 Jan 2006
Last updated: 6 Sep 2019
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 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-Label, Parallel-Group, Multicentre, Phase II Study to Compare the Efficacy and Tolerability of Fulvestrant (FASLODEX™) 500 mg With Anastrozole (ARIMIDEX™) 1 mg as First Line Hormonal Treatment for Postmenopausal Women With Hormone Receptor Positive Advanced Breast Cancer
ClinicalTrials.gov ID: NCT00274469
Acronym / sponsor ID: FIRST / D6995C00006
Conditions: Metastatic Breast Cancer
Keywords: oncology, cancer, breast cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 205 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 6 Feb 2006 (actual)
Primary completion: 10 Jan 2008 (actual)
Study completion: 13 Jan 2017 (actual)
First posted: 11 Jan 2006 (estimated)
Results: Posted 12 Aug 2009

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	Experimental	Drug: fulvestrantFulvestrant
2	Active comparator	Drug: anastrozoleAnastrozole

Who may qualify

Ages: 45 to 100 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Confirmed hormone receptor positive advanced breast cancer, postmenopausal women

Key exclusion criteria (1 listed)

Previous treatment for advanced breast cancer (previous treatment for early breast cancer is allowed).

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, ZD9238500 mg intramuscular injection	Drug	1
anastrozoleAlso: Arimidex, ZD10331 mg oral tablet	Drug	2

Primary outcome

Clinical Benefit Rate
Time frame: From randomisation to data cut off (DCO) for primary analysis. The first and the last patients were enrolled on 6 Feb 2006 and 11 Jul 2007 respectively. The DCO for primary analysis was on 10th Jan 2008, 6 months after the last patient was enrolled.
A Clinical Benefit (CB) responder is defined as a patient having a best overall response of either complete response (CR), partial response (PR) or stable disease (SD) for at least 24 weeks evaluated according to modified RECIST. The Clinical Benefit Rate is the percentage of patients with CB.

4 secondary outcomes

Objective Response Rate
Time frame: From randomisation to data cut off (DCO) for primary analysis. The first and the last patients were enrolled on 6 Feb 2006 and 11 Jul 2007 respectively. The DCO for primary analysis was on 10th Jan 2008, 6 months after the last patient was enrolled.
Time to Progression
Time frame: From randomisation to data cut off (DCO) for primary analysis. The first and the last patients were enrolled on 6 Feb 2006 and 11 Jul 2007 respectively. The DCO for primary analysis was on 10th Jan 2008, 6 months after the last patient was enrolled.
Time to Treatment Failure
Time frame: From randomisation to data cut off (DCO) for 75% treatment failure. The first and the last patients were enrolled on 6 Feb 2006 and 11 Jul 2007. The DCO for 75% treatment failure was on 26 Mar 2010, 32 months after the last patient was enrolled.
Time to Progression (Investigator Assessed)
Time frame: From randomisation to data cut off (DCO) for 75% treatment failure. The first and the last patients were enrolled on 6 Feb 2006 and 11 Jul 2007. The DCO for 75% treatment failure was on 26 Mar 2010, 32 months after the last patient was enrolled.

Results and safety

Results posted to the registry on 12 Aug 2009, 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 500 mg	102	23
Anastrozole 1 mg	103	10

Primary outcome: Clinical Benefit Rate

Time frame: From randomisation to data cut off (DCO) for primary analysis. The first and the last patients were enrolled on 6 Feb 2006 and 11 Jul 2007 respectively. The DCO for primary analysis was on 10th Jan 2008, 6 months after the last patient was enrolled.. Number. Unit: Percentage of Participants

Measure	Fulvestrant 500 mg n = 102	Anastrozole 1 mg n = 103
Value	72.5	67.0

Fulvestrant 500 mg vs Anastrozole 1 mg: Odds Ratio (OR): 1.302 (95% CI 0.717 to 2.380), p = 0.386, Regression, Logistic

Population analysed: Full Analysis Set

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Non-serious adverse events = randomisation upto the point of data cut off for the primary efficacy analysis. Serious adverse events = randomisation up to the point of data cut off for the 65% overall survival analysis.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fulvestrant 500 mg	24 of 101 (23.8%)	71 of 101 (70.3%)	63 of 102
Anastrozole 1 mg	22 of 103 (21.4%)	70 of 103 (68%)	74 of 103

Limitations and caveats (from the sponsor): One patient in the ITT population was randomized to Fulvestrant 500 but did not receive drug and was excluded from the safety population. Hence, the safety population for Fulvestrant contained 101 patients.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
CSR-D6995C00006.pdfLink provided by the sponsor.
D6995C00006FIRSToverall\_survivalRevisedCSP\_4\_10\_December\_2014\_RedactedLink provided by the sponsor.

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RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
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Augmented-Reality ICG Fluorescence Second-Look for Residual Nodal Disease After Axillary Dissection in Breast Cancer
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RecruitingPhase 2
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RecruitingObservational study
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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

41 sites in 9 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing fulvestrant and anastrozole in people with Metastatic Breast Cancer, run by AstraZeneca at 41 sites in 9 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 1 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 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in Bulgaria, Brazil, Czechia, United States, Spain and 4 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 12 Aug 2009). 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?

Clinical Benefit Rate (time frame: From randomisation to data cut off (DCO) for primary analysis. The first and the last patients were enrolled on 6 Feb 2006 and 11 Jul 2007 respectively. The DCO for primary analysis was on 10th Jan 2008, 6 months after the last patient was enrolled.). 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 NCT00274469.

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 Sep 2019.