Faslodex Advanced Breast Cancer Local Chinese Study

January 24, 2011 updated by: AstraZeneca

A Double Blind, Double Dummy, Randomised, Multicentre Study to Compare the Efficacy and Safety of Fulvestrant 250mg With Arimidex 1mg as a Secondary-line Therapy in the Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer

This study will evaluate the efficacy and safety of Faslodex as secondary-line treatment compared with Arimidex in oestrogen receptor positive postmenopausal advanced breast cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

234

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

  • China
      • Beijing, China
        • Research Site
      • Dalian, China
        • Research Site
      • Fuzhou, China
        • Research Site
      • Guangzhou, China
        • Research Site
      • Hankou, China
        • Research Site
      • He Fei, China
        • Research Site
      • Huangzhou, China
        • Research Site
      • Ji Nan, China
        • Research Site
      • Nanjing, China
        • Research Site
      • Shanghai, China
        • Research Site
      • Wuhan, China
        • Research Site
      • Xi AN, China
        • 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Postmenopausal advanced breast cancer with oestrogen receptor positive
  • Progression under first-line anti-oestrogen therapy.

Exclusion Criteria:

  • Life-threatening metastasis; contraindication to anastrozole
  • >2 regimens of hormonotherapy for advanced breast cancer

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
Anastrozole
Drug: Anastrozole
1 mg tablet
Other Names:
  • ZD1033
  • Arimidex
Experimental: 2
Anastrozole + Fulvestrant
Drug: Anastrozole
1 mg tablet
Other Names:
  • ZD1033
  • Arimidex
Drug: Fulvestrant
250 mg intramuscular injection
Other Names:
  • Faslodex
  • ZD9238

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time to Disease Progression (TTP)

Secondary Outcome Measures

Outcome Measure
Objective Response Rate (ORR)
Clinical Benefit Rate (CBR)
Time to Treatment Failure (TTF)
Safety & Tolerability.

Collaborators and Investigators

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

Sponsor

AstraZeneca

Investigators

  • Study Director: Breast Cancer Established Brands Team Medical Science Director, MD, AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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, 2005

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

May 18, 2006

First Submitted That Met QC Criteria

May 18, 2006

First Posted (Estimate)

May 19, 2006

Study Record Updates

Last Update Posted (Estimate)

January 25, 2011

Last Update Submitted That Met QC Criteria

January 24, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D6997L00004

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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