Fulvestrant (FASLODEX™) as a Treatment in Postmenopausal Women With Estrogen Receptor Positive Breast Cancer

June 11, 2008 updated by: AstraZeneca

A Randomized, Open-Label, Multicenter, Phase II Study Comparing the Effects on Proliferation and the Efficacy and Tolerability of Fulvestrant (FASLODEX®) 500 mg With Fulvestrant (FASLODEX®) 250 mg When Given as Neoadjuvant Treatment in Postmenopausal Women With Estrogen Receptor Positive Breast Cancer (T2, 3, 4b, N0-3, M0).

The purpose of this study is to evaluate fulvestrant in the preliminary stage of breast cancer treatment and assess the relationship between dose, exposure, degree of reduction in tumor markers, and efficacy in postmenopausal women with estrogen receptor positive disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

179

Phase

  • Phase 2

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

  • Austria
      • Innsbruck, Austria
        • Research Site
      • Salzburg, Austria
        • Research Site
      • Vienna, Austria
        • Research Site
      • Wien, Austria
        • Research Site
  • Brazil
      • Barretos, Brazil
        • Research Site
      • Florianopolis, Brazil
        • Research Site
      • Goiamia, Brazil
        • Research Site
      • Porto Alegre, Brazil
        • Research Site
      • Rio de Janeiro, Brazil
        • Research Site
      • Santo Andre, Brazil
        • Research Site
      • Sao Paulo, Brazil
        • Research Site
  • Germany
      • Berlin, Germany
        • Research Site
      • Hannover, Germany
        • Research Site
      • Magdeburg, Germany
        • Research Site
      • Munchen, Germany
        • Research Site
      • Rostock, Germany
        • Research Site
  • India
      • Bangalore, India
        • Research Site
      • Hyderabaad, India
        • Research Site
      • New Delhi, India
        • Research Site
      • Pune, India
        • Research Site
      • Trivandrum, India
        • Research Site
  • United Kingdom
      • Birmingham, United Kingdom
        • Research Site
      • Bournemouth, United Kingdom
        • Research Site
      • Dundee, United Kingdom
        • Research Site
      • Edinburgh, United Kingdom
        • Research Site
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, United States
        • Research Site
      • Winchester, Massachusetts, United States
        • Research Site
    • New Mexico
      • Albuquerque, New Mexico, United States
        • Research Site
    • Pennsylvania
      • Hershey, Pennsylvania, United States
        • Research Site
    • Tennessee
      • Nashville, Tennessee, United States
        • Research Site
    • Texas
      • Laredo, Texas, United States
        • 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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Postmenopausal women defined as women who have stopped having menstrual periods
  • Written informed consent to participate in the trial
  • Biopsy confirmation of invasive breast cancer
  • Evidence of hormone sensitivity
  • Willingness to undergo biopsies

Exclusion Criteria:

  • Any previous treatment for breast cancer
  • Unwillingness to stop taking any drug known to affect sex hormonal status or a patient in which it would be inappropriate to stop.
  • Any severe concurrent condition that would preclude surgery or that would jeopardize compliance with the study, e.g., uncontrolled cardiac disease or uncontrolled diabetes mellitus
  • The presence of more than one primary tumor
  • History of hypersensitivity to castor oil
  • History of known bleeding disorders

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
250 mg fulvestrant
Drug: Fulvestrant
250 mg & 500 mg intramuscular injection
Other Names:
  • ZD9238
  • FASLODEX™
Experimental: 2
500 mg fulvestrant
Drug: Fulvestrant
250 mg & 500 mg intramuscular injection
Other Names:
  • ZD9238
  • FASLODEX™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Anti-proliferative effect after 4 weeks of treatment.

Secondary Outcome Measures

Outcome Measure
Safety, tolerability, tumor response and pharmacokinetics after 4 weeks of treatment.

Collaborators and Investigators

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

Sponsor

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.

Helpful Links

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

June 1, 2004

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

September 28, 2004

First Submitted That Met QC Criteria

September 28, 2004

First Posted (Estimate)

September 29, 2004

Study Record Updates

Last Update Posted (Estimate)

June 12, 2008

Last Update Submitted That Met QC Criteria

June 11, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9238IL/0065
  • D6997C00003

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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