Faslodex 500mg multiple dose tolerability study in BC patients

Study identifier:D6995C00004

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

An open, multicentre Phase I clinical study to assess the tolerability of fulvestrant 500 mg in postmenopausal women with hormone receptor positive advanced or recurrent breast cancer

Medical condition

Advanced breast cancer

Phase

Phase 1

Healthy volunteers

No

Study drug

Fulvestrant

Sex

Female

Actual Enrollment

20

Study type

Interventional

Age

18 Years +

Date

Study Start Date: 01 Apr 2004
Primary Completion Date: 01 Apr 2006
Study Completion Date: 01 Jun 2010

Study design

Allocation: Non-randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals

Sponsors

AstraZeneca Pharmaceuticals

Collaborators

-

Inclusion and exclusion criteria