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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00241449
• Other study ID #: 9238IL/0025
• Status: Completed
• Phase: Phase 3
• First received: October 17, 2005
• Last updated: June 5, 2012
• Start date: November 1998
• Est. completion date: January 2012

Study information

• Verified date: June 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: January 2012
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Metastasis

Intervention

Drug:
• Fulvestrant
intramuscular injection 250 mg
• Tamoxifen
20 mg oral tablet

Locations

Country	Name	City	State
Argentina	Research Site	Buenos Aires
Argentina	Research Site	Rosario
Australia	Research Site	Camperdown
Australia	Research Site	Concord
Australia	Research Site	Heidelburg
Australia	Research Site	Melbourne
Austria	Research Site	Salzburg
Austria	Research Site	Wien
Belgium	Research Site	Antwerpen
Belgium	Research Site	Haine-Saint Paul
Belgium	Research Site	Hasselt
Belgium	Research Site	Leuven
Brazil	Research Site	Belo Horizonte
Brazil	Research Site	Goiania
Brazil	Research Site	Sao Paulo
Canada	Research Site	Chicoutimi
Canada	Research Site	Edmonton	Alberta
Canada	Research Site	Montreal
Canada	Research Site	Newmarket	Ontario
Canada	Research Site	Ottawa	Ontario
Canada	Research Site	Penticton	British Columbia
Canada	Research Site	Saint John	New Brunswick
Canada	Research Site	Toronto	Ontario
Canada	Research Site	Weston	Ontario
Canada	Research Site	York	Ontario
Finland	Research Site	Kotka
Finland	Research Site	Kuopio
Finland	Research Site	Rovaniemi
France	Research Site	Clermont Ferrand
France	Research Site	Evreux
France	Research Site	Lyon
France	Research Site	Montpellier
France	Research Site	Pierre-Benite
France	Research Site	Rodez
France	Research Site	Rouen
France	Research Site	Tours
Germany	Research Site	Frankfurt
Germany	Research Site	Gottingen
Germany	Research Site	Rostock
Hungary	Research Site	Budapest
Hungary	Research Site	Pécs
Hungary	Research Site	Székesfehérvár
Hungary	Research Site	Szolnok
Ireland	Research Site	Dublin
Israel	Research Site	Ashkelon
Israel	Research Site	Haifa
Italy	Research Site	Bologna
Italy	Research Site	Brescia
Italy	Research Site	Forli
Italy	Research Site	Genova
Italy	Research Site	Milano
Italy	Research Site	Napoli
Italy	Research Site	Palermo
Italy	Research Site	Perugia
Italy	Research Site	Pisa
Italy	Research Site	Reggio Calabria
Italy	Research Site	Reggio Emilia
Italy	Research Site	Rozzano
Italy	Research Site	Sassari
Italy	Research Site	Trieste
Japan	Research Site	Amagasaki
Japan	Research Site	Fukuoka
Japan	Research Site	Kitakyusyu
Japan	Research Site	Kumamoto
Japan	Research Site	Matsuyama
Japan	Research Site	Nagoya
Japan	Research Site	Niigata
Japan	Research Site	Oita
Japan	Research Site	Osaka
Japan	Research Site	Saitama
Japan	Research Site	Sapporo
Japan	Research Site	Suita
Japan	Research Site	Tokyo
Mexico	Research Site	Guadalajara
Mexico	Research Site	Mexico, D.F.
Netherlands	Research Site	Den Haag
New Zealand	Research Site	Christchurch
New Zealand	Research Site	Palmerston North
Poland	Research Site	Bydgoszcz
Poland	Research Site	Krakow
Poland	Research Site	Szczecin
Poland	Research Site	Warszawa
Portugal	Research Site	Coimbra
Russian Federation	Research Site	Moscow
South Africa	Research Site	Cape Town
South Africa	Research Site	Johannesburg
South Africa	Research Site	Lyttelton Manor
Spain	Research Site	Badalona
Spain	Research Site	Guadalajara
Spain	Research Site	Madrid
Spain	Research Site	Málaga
Taiwan	Research Site	Kaohsiung
Taiwan	Research Site	Taichung
Taiwan	Research Site	Tainan
Taiwan	Research Site	Taipei
Taiwan	Research Site	Tao-Yuan
Turkey	Research Site	Istanbul
United Kingdom	Research Site	Belfast
United Kingdom	Research Site	Birmingham
United Kingdom	Research Site	Chelmsford
United Kingdom	Research Site	Chorley
United Kingdom	Research Site	Coventry
United Kingdom	Research Site	Huddersfield
United Kingdom	Research Site	Leeds
United Kingdom	Research Site	London
United Kingdom	Research Site	Luton
United Kingdom	Research Site	Manchester
United Kingdom	Research Site	Newcastle Upon Tyne
United Kingdom	Research Site	Northampton
United Kingdom	Research Site	Nottingham
United Kingdom	Research Site	Prescot
United Kingdom	Research Site	Telford
United Kingdom	Research Site	Whitehaven
United Kingdom	Research Site	Worthing
United Kingdom	Research Site	York
United States	Research Site	Austin	Texas
United States	Research Site	Chicago	Illinois
United States	Research Site	Columbus	Ohio
United States	Research Site	Decatur	Georgia
United States	Research Site	Detroit	Michigan
United States	Research Site	Fountain Valley	California
United States	Research Site	Galveston	Texas
United States	Research Site	Gloucester	Massachusetts
United States	Research Site	Houston	Texas
United States	Research Site	La Jolla	California
United States	Research Site	Lacey	Washington
United States	Research Site	Little Rock	Arkansas
United States	Research Site	Mason City	Iowa
United States	Research Site	Meadowbrook	Pennsylvania
United States	Research Site	Orange	California
United States	Research Site	Providence	Rhode Island
United States	Research Site	Richmond	Virginia
United States	Research Site	San Antonio	Texas
United States	Research Site	Seattle	Washington
United States	Research Site	Shreveport	Louisiana
United States	Research Site	Temple	Texas
United States	Research Site	Venice	Florida
United States	Research Site	Voorhees	New Jersey
United States	Research Site	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  Finland,  France,  Germany,  Hungary,  Ireland,  Israel,  Italy,  Japan,  Mexico,  Netherlands,  New Zealand,  Poland,  Portugal,  Russian Federation,  South Africa,  Spain,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Yes
Secondary	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	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.	Yes
Secondary	Duration of response (DoR)		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.	Yes
Secondary	Time to treatment failure (TTF)		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.	Yes
Secondary	Overall survival (OS)		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.	Yes
Secondary	Quality of Life (QOL) and Tolerability.		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.	Yes

External Links

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