Phase II Metastatic ER+/PgR+ Nolvadex +/- Iressa Study
Study identifier:1839IL/0225
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Recruitment Complete
Official Title
A Phase II Randomised, Double-Blind, Stratified, Multi-Centre Trial comparing the Nolvadex 20 Mg And Placebo Combination To The Nolvadex 20 Mg and ZD1839 (IRESSA™) 250 MG Combination In Patients With Metastatic Breast Cancer And Estrogen Receptor (ER) and/or Progesterone (PR) Positive Tumours
Medical condition
Breast Neoplasms
Phase
Phase 2
Healthy volunteers
No
Study drug
Gefitinib, Tamoxifen
Sex
Female
Actual Enrollment
317
Study type
Interventional
Age
18 Years - 150 Years
Date
Study Start Date: 01 Oct 2003
Primary Completion Date: 01 Dec 2006
Estimated Study Completion Date: 01 Dec 2015
Study design
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Mar 2015 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 ZD1839 + Nolvadex | - |
| Other: 2 Nolvadex + placebo | - |
Contacts
Investigators
Principal Investigator
AstraZeneca Iressa Medical Science Director
AstraZeneca
