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

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