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

NCT00241449 | Completed Phase 3

• 1 other identifier: 9238IL/0025
• Study Type: interventional
• Target: 51
• Locations: 25 countries
• Sites: 137

Brief 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.

Conditions

Breast Cancer; Metastasis

Keywords

Locally advanced breast cancer or metastatic breast cancer

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (5)

• Objective response rate (ORR)

  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)

  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)

  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)

  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.

  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.

Study Arms (2)

1

ACTIVE COMPARATOR

Tamoxifen

Drug: Tamoxifen

2

EXPERIMENTAL

Fulvestrant

Drug: Fulvestrant

Interventions

Fulvestrant DRUG

intramuscular injection 250 mg

Also known as: Faslodex, ZD9238

2

Tamoxifen DRUG

20 mg oral tablet

Also known as: Nolvadex

1

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (139)

Research Site

Little Rock, Arkansas, United States

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Fountain Valley, California, United States

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La Jolla, California, United States

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Orange, California, United States

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Washington D.C., District of Columbia, United States

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Venice, Florida, United States

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Decatur, Georgia, United States

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Chicago, Illinois, United States

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Mason City, Iowa, United States

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Shreveport, Louisiana, United States

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Gloucester, Massachusetts, United States

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Detroit, Michigan, United States

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Voorhees Township, New Jersey, United States

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Columbus, Ohio, United States

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Meadowbrook, Pennsylvania, United States

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Providence, Rhode Island, United States

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Austin, Texas, United States

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Galveston, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Temple, Texas, United States

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Richmond, Virginia, United States

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Lacey, Washington, United States

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Seattle, Washington, United States

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Buenos Aires, Argentina

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Rosario, Argentina

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Camperdown, Australia

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Concord, Australia

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Heidelburg, Australia

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Melbourne, Australia

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Salzburg, Austria

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Vienna, Austria

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Antwerp, Belgium

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Haine-Saint-Paul, Belgium

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Hasselt, Belgium

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Leuven, Belgium

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Belo Horizonte, Brazil

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Goiânia, Brazil

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São Paulo, Brazil

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Edmonton, Alberta, Canada

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Penticton, British Columbia, Canada

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Saint John, New Brunswick, Canada

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Newmarket, Ontario, Canada

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Ottawa, Ontario, Canada

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Toronto, Ontario, Canada

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Weston, Ontario, Canada

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York, Ontario, Canada

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Chicoutimi, Canada

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Montreal, Canada

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Kotka, Finland

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Kuopio, Finland

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Rovaniemi, Finland

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Clermont-Ferrand, France

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Évreux, France

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Lyon, France

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Montpellier, France

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Pierre-Bénite, France

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Rodez, France

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Rouen, France

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Tours, France

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Frankfurt, Germany

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Göttingen, Germany

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Rostock, Germany

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Budapest, Hungary

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Pécs, Hungary

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Székesfehérvár, Hungary

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Szolnok, Hungary

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Dublin, Ireland

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Ashkelon, Israel

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Haifa, Israel

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Bologna, Italy

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Brescia, Italy

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Forlì, Italy

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Genova, Italy

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Milan, Italy

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Napoli, Italy

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Palermo, Italy

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Perugia, Italy

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Pisa, Italy

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Reggio Calabria, Italy

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Reggio Emilia, Italy

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Rozzano, Italy

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Sassari, Italy

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Trieste, Italy

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Amagasaki, Japan

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Fukuoka, Japan

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Kitakyushu, Japan

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Kumamoto, Japan

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Matsuyama, Japan

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Nagoya, Japan

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Niigata, Japan

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Osaka, Japan

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Ōita, Japan

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Saitama, Japan

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Sapporo, Japan

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Suita, Japan

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Tokyo, Japan

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Guadalajara, Mexico

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Mexico City, Mexico

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The Hague, Netherlands

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Christchurch, New Zealand

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Palmerston North, New Zealand

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Bydgoszcz, Poland

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Krakow, Poland

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Szczecin, Poland

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Warsaw, Poland

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Coimbra, Portugal

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Moscow, Russia

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Cape Town, South Africa

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Johannesburg, South Africa

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Lyttelton Manor, South Africa

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Badalona, Spain

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Guadalajara, Spain

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Madrid, Spain

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Málaga, Spain

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Kaohsiung City, Taiwan

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Taichung, Taiwan

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Tainan, Taiwan

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Taipei, Taiwan

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Taoyuan District, Taiwan

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Istanbul, Turkey (Türkiye)

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Belfast, United Kingdom

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Birmingham, United Kingdom

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Chelmsford, United Kingdom

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Chorley, United Kingdom

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Coventry, United Kingdom

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Huddersfield, United Kingdom

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Leeds, United Kingdom

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London, United Kingdom

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Luton, United Kingdom

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Manchester, United Kingdom

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Newcastle upon Tyne, United Kingdom

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Northampton, United Kingdom

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Nottingham, United Kingdom

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Prescot, United Kingdom

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Telford, United Kingdom

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Whitehaven, United Kingdom

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Worthing, United Kingdom

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York, United Kingdom

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MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

Interventions

Fulvestrant; Tamoxifen

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• AstraZeneca Oncology Medical Science Director, MD

  AstraZeneca

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2005
• First Posted: October 19, 2005
• Study Start: November 1, 1998
• Primary Completion: March 1, 2007
• Study Completion: January 1, 2012
• Last Updated: June 6, 2012

Record last verified: 2012-06

Locations

AR (2); HU (4); US (24); IL (2); FR (8); NZ (2); IE (1); TW (5); BE (4); BR (3); JP (13); CA (10); DE (3); AU (4); GB (18); ME (2); IT (14); PL (4); ES (4); ZA (3); TU (1); NL (1); RU (1); FI (3); PT (1)