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

Study identifier:9238IL/0065

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

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).

Medical condition

Breast Cancer

Phase

Phase 2

Healthy volunteers

No

Study drug

Fulvestrant

Sex

Female

Actual Enrollment

179

Study type

Interventional

Age

N/A

Date

Study Start Date: 01 Jun 2004
Primary Completion Date: -
Study Completion Date: 01 Jul 2007

Study design

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals

Sponsors

AstraZeneca Pharmaceuticals

Collaborators

-

Inclusion and exclusion criteria