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

Tracking Information

First Received Date ^ICMJE

September 28, 2004

Last Updated Date

June 11, 2008

Start Date ^ICMJE

June 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Anti-proliferative effect after 4 weeks of treatment.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00093002 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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).

Brief Summary

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.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Breast Cancer

Intervention ^ICMJE

Drug: Fulvestrant

Study Arms / Comparison Groups

Experimental: 250 mg fulvestrant
Experimental: 500 mg fulvestrant

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

179

Completion Date

July 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Austria, Brazil, Germany, India, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00093002

Responsible Party

Study ID Numbers ^ICMJE

9238IL/0065, D6997C00003

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

AstraZeneca Faslodex Medical Science Director, MD

AstraZeneca

Information Provided By

AstraZeneca

Verification Date

June 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP