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

AstraZeneca1 site in 1 country51 target enrollmentNovember 1998

ConditionsBreast Cancer Metastasis

InterventionsTamoxifen Fulvestrant

DrugsFulvestrant Tamoxifen

Overview

Phase: Phase 3
Intervention: Tamoxifen
Conditions: Breast Cancer
Sponsor: AstraZeneca
Enrollment: 51
Locations: 1
Primary Endpoint: Time to disease progression (TTP)
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 1998

End Date

January 2012

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

AstraZeneca

Responsible Party

Sponsor

Eligibility Criteria

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.

Arms & Interventions

1

Tamoxifen

Intervention: Tamoxifen

2

Fulvestrant

Intervention: Fulvestrant

Outcomes

Primary Outcomes

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

Secondary Outcomes

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.)