PROACT - Pre-Operative Arimidex Compared To Tamoxifen

Study identifier:1033IL/0039

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A randomised, double-blind, study comparing ARIMIDEX™ with NOLVADEX™ as neo-adjuvant and adjuvant treatment in post-menopausal women with large operable (T2 (≥3cm), T3, N0-2, M0) or potentially-operable, locally advanced (T4b, N0-2, M0), ER+ and/or PR+ breast cancer.

Medical condition

Breast Cancer

Phase

Phase 3

Healthy volunteers

No

Study drug

ARIMIDEX (anastrazole), NOLVADEX (tamoxifen)

Sex

Female

Actual Enrollment

452

Study type

Interventional

Age

60 Years +

Date

Study Start Date: 01 Aug 2000
Primary Completion Date: 01 Jan 2003
Study Completion Date: 01 Dec 2007

Study design

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Dec 2013 by AstraZeneca Pharmaceuticals

Sponsors

AstraZeneca Pharmaceuticals

Collaborators

-

Inclusion and exclusion criteria