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).

AstraZeneca1 site in 1 country179 target enrollmentJune 2004

ConditionsBreast Cancer

InterventionsFulvestrant

DrugsFulvestrant

Overview

Phase: Phase 2
Intervention: Fulvestrant
Conditions: Breast Cancer
Sponsor: AstraZeneca
Enrollment: 179
Locations: 1
Primary Endpoint: Anti-proliferative effect after 4 weeks of treatment.
Status: Completed
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2004

End Date

July 2007

Last Updated

17 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

AstraZeneca

Eligibility Criteria

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