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
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 250 mg fulvestrant | Drug: Fulvestrant 250 mg & 500 mg intramuscular injection Other Name: FASLODEX™ Other Name: ZD9238 |
| Experimental: 2 500 mg fulvestrant | Drug: Fulvestrant 250 mg & 500 mg intramuscular injection Other Name: FASLODEX™ Other Name: ZD9238 |
Contacts
Investigators
Principal Investigator
AstraZeneca Faslodex Medical Science Director
AstraZeneca
