Official Title: “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 Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: March 2007

Intervention(s) in this Clinical Trial

• Drug: Fulvestrant
  • intramuscular injection 250 mg
• Drug: Tamoxifen
  • 20 mg oral tablet

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Tamoxifen
• Experimental: 2
  • Fulvestrant

Primary Measures

• Time to disease progression (TTP)

Secondary Measures

• Objective response rate (ORR), Duration of response (DoR), Time to treatment failure (TTF), Overall survival (OS), Quality of Life (QOL) and Tolerability.

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.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

AstraZeneca Oncology Medical Science Director, MD Study Director AstraZeneca  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00241449

Study ID Number: 9238IL/0025

ClinicalTrials.gov Identifier: NCT00241449

Health Authority: United States: Food and Drug Administration