Breast CancerPhase 3NCT00241449

A Trial Comparing the Efficacy and Tolerability of Faslodex With Nolvadex in Postmenopausal Women With Advanced Breast Cancer

A Phase 3 study testing Fulvestrant and Tamoxifen in people with Breast Cancer and Metastasis, run by AstraZeneca at 139 sites in 26 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

Who is it for?: Any age, women only
Conditions the study is for: Breast Cancer, Metastasis
What is being tested?: Fulvestrant and Tamoxifen
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 51 participants
Where: 139 sitesin 26 countries
Study dates: Nov 1998to Jan 2012
Phase: Phase 3
Are there results?: None posted in the registry

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

Biopsy confirmation of breast cancer. Evidence of breast cancer that is not considered amenable to curative treatment.
Postmenopausal women. Written informed consent to participate in the study.

Who cannot join

Previous treatment with hormonal therapy unless that therapy was tamoxifen for adjuvant breast cancer. The use of tamoxifen must have ceased at least one year before this study.
Previous treatment with Faslodex. Any existing serious disease, illness, or condition that will prevent participation or compliance with the study procedures.
Treatment with an investigational or non-approved drug within one month of then start of the study.

Trial locations and contacts

139 sites in 26 countries.

Country

City, postcode or hospital

139 sites in 26 countries

United States24 sites

Research Site
Austin, Texas
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Chicago, Illinois
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Columbus, Ohio
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Decatur, Georgia
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Detroit, Michigan
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Fountain Valley, California
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Galveston, Texas
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Gloucester, Massachusetts
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Houston, Texas
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La Jolla, California
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Lacey, Washington
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Little Rock, Arkansas
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Mason City, Iowa
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Meadowbrook, Pennsylvania
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Orange, California
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Providence, Rhode Island
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Richmond, Virginia
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San Antonio, Texas
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Seattle, Washington
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Shreveport, Louisiana
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Temple, Texas
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Venice, Florida
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Voorhees Township, New Jersey
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Washington D.C., District of Columbia

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United Kingdom18 sites

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Belfast
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Birmingham
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Chelmsford
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Chorley
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Coventry
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Huddersfield
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Leeds
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London
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Luton
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Manchester
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Newcastle upon Tyne
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Northampton
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Nottingham
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Prescot
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Telford
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Whitehaven
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Worthing
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York

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Italy14 sites

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Bologna
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Brescia
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Forlì
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Genova
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Milan
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Naples
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Palermo
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Perugia
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Pisa
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Reggio Calabria
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Reggio Emilia
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Rozzano
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Sassari
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Trieste

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Japan13 sites

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Amagasaki
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Fukuoka
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Kitakyushu
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Kumamoto
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Matsuyama
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Nagoya
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Niigata
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Ōita
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Osaka
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Saitama
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Sapporo
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Suita
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Tokyo

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Canada10 sites

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Chicoutimi
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Edmonton, Alberta
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Montreal
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Newmarket, Ontario
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Ottawa, Ontario
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Penticton, British Columbia
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Saint John, New Brunswick
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Toronto, Ontario
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Weston, Ontario
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York, Ontario

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France8 sites

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Clermont-Ferrand
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Évreux
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Lyon
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Montpellier
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Pierre-Bénite
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Rodez
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Rouen
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Tours

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Taiwan5 sites

Research Site
Kaohsiung City
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Taichung
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Tainan
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Taipei
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Taoyuan

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Australia4 sites

Research Site
Camperdown
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Concord
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Heidelburg
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Melbourne

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Belgium4 sites

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Antwerp
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Haine-Saint-Paul
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Hasselt
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Leuven

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Hungary4 sites

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Budapest
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Pécs
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Székesfehérvár
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Szolnok

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Poland4 sites

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Bydgoszcz
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Krakow
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Szczecin
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Warsaw

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Spain4 sites

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Badalona
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Guadalajara
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Madrid
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Málaga

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Brazil3 sites

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Belo Horizonte
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Goiânia
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São Paulo

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Finland3 sites

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Kotka
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Kuopio
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Rovaniemi

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Germany3 sites

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Frankfurt
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Göttingen
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Rostock

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South Africa3 sites

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Cape Town
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Johannesburg
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Lyttelton Manor

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Argentina2 sites

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Buenos Aires
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Rosario

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Austria2 sites

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Salzburg
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Vienna

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Israel2 sites

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Ashkelon
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Haifa

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Mexico2 sites

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Guadalajara
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Mexico City

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New Zealand2 sites

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Christchurch
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Palmerston North

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Ireland1 site

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Dublin

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Netherlands1 site

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The Hague

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Portugal1 site

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Coimbra

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Russia1 site

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Moscow

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Turkey (Türkiye)1 site

Research Site
Istanbul

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About this study

Official title: A Double-blind, Randomized, Multicentre Trial Comparing the Efficacy and Tolerability of 250mg of Faslodex (Long Acting ICI 182,780) With 20mg of Nolvadex (Tamoxifen) in Postmenopausal Women With Advanced Breast Cancer

The purpose of this study is to compare the efficacy of Faslodex (fulvestrant) to Nolvadex (tamoxifen) as first-line treatment for postmenopausal women with advanced breast cancer. Patients will be treated until disease progression or until the investigator has determined that treatment is not in the best interest of the patient, whichever occurs first.

Conditions: Breast Cancer, Metastasis
Being tested: Fulvestrant, Tamoxifen
Keywords: Locally advanced breast cancer or metastatic breast cancer
Medical subject headings: Breast Neoplasms, Neoplasm Metastasis

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
TamoxifenDrug
Also called Nolvadex
20 mg oral tablet

Study groups in NCT00241449
Study group	Role	What they receive
1	Active comparator	Tamoxifen Receives: Drug: Tamoxifen
2	Experimental	Fulvestrant Receives: Drug: Fulvestrant

What is being measured

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

Time to disease progression (TTP)
It is considered that these results indicate that adequate data were available for obtaining clinically meaningful information for the primary efficacy endpoint of time to disease progression
Measured: At the time of data cut-off for this trial, the median overall duration of follow-up was 441 days, with a total of 434 (73.9%) randomised patients, including 47 patients from Japanese centres having progressed.

Secondary outcomes (5)

Objective response rate (ORR)
It is considered that these results indicate that adequate data were available for obtaining clinically meaningful information for the primary efficacy endpoint of time to disease progression
Measured: At the time of data cut-off for this trial, the median overall duration of follow-up was 441 days, with a total of 434 (73.9%) randomised patients, including 47 patients from Japanese centres having progressed.
Duration of response (DoR)
Measured: At the time of data cut-off for this trial, the median overall duration of follow-up was 441 days, with a total of 434 (73.9%) randomised patients, including 47 patients from Japanese centres having progressed.
Time to treatment failure (TTF)
Measured: At the time of data cut-off for this trial, the median overall duration of follow-up was 441 days, with a total of 434 (73.9%) randomised patients, including 47 patients from Japanese centres having progressed.
Overall survival (OS)
Measured: At the time of data cut-off for this trial, the median overall duration of follow-up was 441 days, with a total of 434 (73.9%) randomised patients, including 47 patients from Japanese centres having progressed.
Quality of Life (QOL) and Tolerability.
Measured: At the time of data cut-off for this trial, the median overall duration of follow-up was 441 days, with a total of 434 (73.9%) randomised patients, including 47 patients from Japanese centres having progressed.

Timeline

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

Nov 1998Jan 2012

First posted19 Oct 2005 (estimated)
Study startNov 1998
Primary completionMar 2007
Study completionJan 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 51 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00241449
Sponsor's protocol ID: 9238IL/0025
Status last verified: Jun 2012
First submitted: 17 Oct 2005
Last updated: 6 Jun 2012
Results posted: No

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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Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
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All Breast Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-blind, Randomized, Multicentre Trial Comparing the Efficacy and Tolerability of 250mg of Faslodex (Long Acting ICI 182,780) With 20mg of Nolvadex (Tamoxifen) in Postmenopausal Women With Advanced Breast Cancer
ClinicalTrials.gov ID: NCT00241449
Acronym / sponsor ID: 9238IL/0025
Conditions: Breast Cancer, Metastasis
Keywords: Locally advanced breast cancer or metastatic breast cancer
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 51 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Nov 1998
Primary completion: Mar 2007 (actual)
Study completion: Jan 2012 (actual)
First posted: 19 Oct 2005 (estimated)
Results: Not posted in the source record

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: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
1	Active comparator	Drug: TamoxifenTamoxifen
2	Experimental	Drug: FulvestrantFulvestrant

Who may qualify

Sex: Female only
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (2 listed)

Biopsy confirmation of breast cancer. Evidence of breast cancer that is not considered amenable to curative treatment.
Postmenopausal women. Written informed consent to participate in the study.

Key exclusion criteria (3 listed)

Previous treatment with hormonal therapy unless that therapy was tamoxifen for adjuvant breast cancer. The use of tamoxifen must have ceased at least one year before this study.
Previous treatment with Faslodex. Any existing serious disease, illness, or condition that will prevent participation or compliance with the study procedures.
Treatment with an investigational or non-approved drug within one month of then start of the study.

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	Drug	2
TamoxifenAlso: Nolvadex20 mg oral tablet	Drug	1

Primary outcome

Time to disease progression (TTP)
Time frame: At the time of data cut-off for this trial, the median overall duration of follow-up was 441 days, with a total of 434 (73.9%) randomised patients, including 47 patients from Japanese centres having progressed.
It is considered that these results indicate that adequate data were available for obtaining clinically meaningful information for the primary efficacy endpoint of time to disease progression

5 secondary outcomes

Objective response rate (ORR)
Time frame: At the time of data cut-off for this trial, the median overall duration of follow-up was 441 days, with a total of 434 (73.9%) randomised patients, including 47 patients from Japanese centres having progressed.
Duration of response (DoR)
Time frame: At the time of data cut-off for this trial, the median overall duration of follow-up was 441 days, with a total of 434 (73.9%) randomised patients, including 47 patients from Japanese centres having progressed.
Time to treatment failure (TTF)
Time frame: At the time of data cut-off for this trial, the median overall duration of follow-up was 441 days, with a total of 434 (73.9%) randomised patients, including 47 patients from Japanese centres having progressed.
Overall survival (OS)
Time frame: At the time of data cut-off for this trial, the median overall duration of follow-up was 441 days, with a total of 434 (73.9%) randomised patients, including 47 patients from Japanese centres having progressed.
Quality of Life (QOL) and Tolerability.
Time frame: At the time of data cut-off for this trial, the median overall duration of follow-up was 441 days, with a total of 434 (73.9%) randomised patients, including 47 patients from Japanese centres having progressed.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2012.

Related trials for Breast Cancer

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

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 Oncology Medical Science Director, MD study director

AstraZeneca

139 sites in 26 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fulvestrant and Tamoxifen in people with Breast Cancer and Metastasis, run by AstraZeneca at 139 sites in 26 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 2 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 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 139 sites in United States, United Kingdom, Italy, Japan, Canada and 21 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 disease progression (TTP) (time frame: At the time of data cut-off for this trial, the median overall duration of follow-up was 441 days, with a total of 434 (73.9%) randomised patients, including 47 patients from Japanese centres having progressed.). 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 NCT00241449.

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 Jun 2012.