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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


Phase 3
N/A
N/A
Not Enrolling
Female
Breast Cancer, Metastasis

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Time to disease progression (TTP)

Outcome Description:

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

Outcome 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.

Safety Issue:

Yes

Principal Investigator

AstraZeneca Oncology Medical Science Director, MD

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

United States: Food and Drug Administration

Study ID:

9238IL/0025

NCT ID:

NCT00241449

Start Date:

November 1998

Completion Date:

January 2012

Related Keywords:

  • Breast Cancer
  • Metastasis
  • Locally advanced breast cancer or metastatic breast cancer
  • Breast Neoplasms
  • Neoplasm Metastasis

Name

Location
Research Site Bentonville, Arkansas  
Research Site Anaheim, California  
Research Site Washington, District of Columbia  
Research Site Boca Raton, Florida  
Research Site Albany, Georgia  
Research Site Arlington Heights, Illinois  
Research Site Ames, Iowa  
Research Site Baton Rouge, Louisiana  
Research Site Beverly, Massachusetts  
Research Site Battle Kreek, Michigan  
Research Site Belleville, New Jersey  
Research Site Akron, Ohio  
Research Site Allentown, Pennsylvania  
Research Site Pawtucket, Rhode Island  
Research Site Abilene, Texas  
Research Site Abington, Virginia  
Research Site Auburn, Washington