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

June 5, 2012 updated by: AstraZeneca

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Research Site
      • Rosario, Argentina
        • Research Site
  • Australia
      • Camperdown, Australia
        • Research Site
      • Concord, Australia
        • Research Site
      • Heidelburg, Australia
        • Research Site
      • Melbourne, Australia
        • Research Site
  • Austria
      • Salzburg, Austria
        • Research Site
      • Wien, Austria
        • Research Site
  • Belgium
      • Antwerpen, Belgium
        • Research Site
      • Haine-Saint Paul, Belgium
        • Research Site
      • Hasselt, Belgium
        • Research Site
      • Leuven, Belgium
        • Research Site
  • Brazil
      • Belo Horizonte, Brazil
        • Research Site
      • Goiania, Brazil
        • Research Site
      • Sao Paulo, Brazil
        • Research Site
  • Canada
      • Chicoutimi, Canada
        • Research Site
      • Montreal, Canada
        • Research Site
    • Alberta
      • Edmonton, Alberta, Canada
        • Research Site
    • British Columbia
      • Penticton, British Columbia, Canada
        • Research Site
    • New Brunswick
      • Saint John, New Brunswick, Canada
        • Research Site
    • Ontario
      • Newmarket, Ontario, Canada
        • Research Site
      • Ottawa, Ontario, Canada
        • Research Site
      • Toronto, Ontario, Canada
        • Research Site
      • Weston, Ontario, Canada
        • Research Site
      • York, Ontario, Canada
        • Research Site
  • Finland
      • Kotka, Finland
        • Research Site
      • Kuopio, Finland
        • Research Site
      • Rovaniemi, Finland
        • Research Site
  • France
      • 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, France
        • Research Site
  • Germany
      • Frankfurt, Germany
        • Research Site
      • Gottingen, Germany
        • Research Site
      • Rostock, Germany
        • Research Site
  • Hungary
      • Budapest, Hungary
        • Research Site
      • Pécs, Hungary
        • Research Site
      • Szolnok, Hungary
        • Research Site
      • Székesfehérvár, Hungary
        • Research Site
  • Ireland
      • Dublin, Ireland
        • Research Site
  • Israel
      • Ashkelon, Israel
        • Research Site
      • Haifa, Israel
        • Research Site
  • Italy
      • 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, Italy
        • Research Site
  • Japan
      • 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, Japan
        • Research Site
  • Mexico
      • Guadalajara, Mexico
        • Research Site
      • Mexico, D.F., Mexico
        • Research Site
  • Netherlands
      • Den Haag, Netherlands
        • Research Site
  • New Zealand
      • Christchurch, New Zealand
        • Research Site
      • Palmerston North, New Zealand
        • Research Site
  • Poland
      • Bydgoszcz, Poland
        • Research Site
      • Krakow, Poland
        • Research Site
      • Szczecin, Poland
        • Research Site
      • Warszawa, Poland
        • Research Site
  • Portugal
      • Coimbra, Portugal
        • Research Site
  • Russian Federation
      • Moscow, Russian Federation
        • Research Site
  • South Africa
      • Cape Town, South Africa
        • Research Site
      • Johannesburg, South Africa
        • Research Site
      • Lyttelton Manor, South Africa
        • Research Site
  • Spain
      • Badalona, Spain
        • Research Site
      • Guadalajara, Spain
        • Research Site
      • Madrid, Spain
        • Research Site
      • Málaga, Spain
        • Research Site
  • Taiwan
      • Kaohsiung, Taiwan
        • Research Site
      • Taichung, Taiwan
        • Research Site
      • Tainan, Taiwan
        • Research Site
      • Taipei, Taiwan
        • Research Site
      • Tao-Yuan, Taiwan
        • Research Site
  • Turkey
      • Istanbul, Turkey
        • Research Site
  • United Kingdom
      • 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 Kingdom
        • Research Site
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States
        • Research Site
    • California
      • Fountain Valley, California, United States
        • Research Site
      • La Jolla, California, United States
        • Research Site
      • Orange, California, United States
        • Research Site
    • District of Columbia
      • Washington, District of Columbia, United States
        • Research Site
    • Florida
      • Venice, Florida, United States
        • Research Site
    • Georgia
      • Decatur, Georgia, United States
        • Research Site
    • Illinois
      • Chicago, Illinois, United States
        • Research Site
    • Iowa
      • Mason City, Iowa, United States
        • Research Site
    • Louisiana
      • Shreveport, Louisiana, United States
        • Research Site
    • Massachusetts
      • Gloucester, Massachusetts, United States
        • Research Site
    • Michigan
      • Detroit, Michigan, United States
        • Research Site
    • New Jersey
      • Voorhees, New Jersey, United States
        • Research Site
    • Ohio
      • Columbus, Ohio, United States
        • Research Site
    • Pennsylvania
      • Meadowbrook, Pennsylvania, United States
        • Research Site
    • Rhode Island
      • Providence, Rhode Island, United States
        • Research Site
    • Texas
      • Austin, Texas, United States
        • Research Site
      • Galveston, Texas, United States
        • Research Site
      • Houston, Texas, United States
        • Research Site
      • San Antonio, Texas, United States
        • Research Site
      • Temple, Texas, United States
        • Research Site
    • Virginia
      • Richmond, Virginia, United States
        • Research Site
    • Washington
      • Lacey, Washington, United States
        • Research Site
      • Seattle, Washington, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Tamoxifen
Drug: Tamoxifen
20 mg oral tablet
Other Names:
  • Nolvadex
Experimental: 2
Fulvestrant
Drug: Fulvestrant
intramuscular injection 250 mg
Other Names:
  • Faslodex
  • ZD9238

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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.
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.
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.
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: AstraZeneca Oncology Medical Science Director, MD, AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 1998

Primary Completion (Actual)

March 1, 2007

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

October 17, 2005

First Submitted That Met QC Criteria

October 17, 2005

First Posted (Estimate)

October 19, 2005

Study Record Updates

Last Update Posted (Estimate)

June 6, 2012

Last Update Submitted That Met QC Criteria

June 5, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9238IL/0025

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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