ITA - Clinical Study Comparing ARIMIDEX™ With NOLVADEX™ in Women With Breast Cancer Treated With NOLVADEX for at Least 2 Years

April 30, 2009 updated by: AstraZeneca

An Open Randomised Clinical Study Comparing ARIMIDEX™ With NOLVADEX™ as Adjuvant Therapies in Post-Menopausal Women With Breast Cancer Already Being Treated With NOLVADEX for at Least Two Years

The purpose of this study was to assess the difference in disease-free survival between post-menopausal women with hormone receptor-positive early breast cancer who switched from tamoxifen to anastrozole and those who continued on tamoxifen.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

448

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Arezzo, Italy
        • Research Site
      • Bologna, Italy
        • Research Site
      • Casalpusterlengo, Italy
        • Research Site
      • Catania, Italy
        • Research Site
      • Chieti, Italy
        • Research Site
      • Ferrara, Italy
        • Research Site
      • Firenze, Italy
        • Research Site
      • Forli, Italy
        • Research Site
      • Genova, Italy
        • Research Site
      • Lugo, Italy
        • Research Site
      • Messina, Italy
        • Research Site
      • Milano, Italy
        • Research Site
      • Monserrato, Italy
        • Research Site
      • Palermo, Italy
        • Research Site
      • Pavia, Italy
        • Research Site
      • Pinerolo, Italy
        • Research Site
      • Roma, Italy
        • Research Site
      • Rovigo, Italy
        • Research Site
      • San Remo, Italy
        • Research Site
      • Saronno, Italy
        • Research Site
      • Sassari, Italy
        • Research Site
      • Terni, Italy
        • Research Site
      • Torino, Italy
        • Research Site
      • Trieste, Italy
        • Research Site
      • Vicenza, Italy
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Post-menopausal status; age ≤75 years;
  • histologically confirmed invasive breast cancer with metastases in the axillary lymph nodes;
  • oestrogen receptor status positive or unknown;
  • primary treatment (surgery +/- radiotherapy, +/- chemotherapy) completed

Exclusion Criteria:

  • Clinical evidence of metastatic disease (including local or remote recurrence, even if the patient appeared to be in complete remission at the time of randomisation).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 2
Tamoxifen
Drug: Tamoxifen
oral
Other Names:
  • Nolvadex
Experimental: 1
Anastrozole
Drug: Anastrozole
oral
Other Names:
  • ZD1033
  • Arimidex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The primary objective of this analysis was to assess the difference in disease-free survival between post-menopausal women with hormone receptor-positive early breast cancer who switched from tamoxifen to anastrozole and those who continued on tamoxifen

Secondary Outcome Measures

Outcome Measure
Assess the difference in overall survival/disease recurrence/safety and tolerability between post-menopausal women with hormone receptor-positive early breast cancer who switched from tamoxifen to anastrozole and those who continued to receive tamoxifen.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Collaborators

Institute of Cancer Research, United Kingdom

Investigators

  • Principal Investigator: Francesco Boccardo, MD, University and National Cancer Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 1998

Study Completion (Actual)

May 1, 2006

Study Registration Dates

First Submitted

February 2, 2006

First Submitted That Met QC Criteria

February 2, 2006

First Posted (Estimate)

February 3, 2006

Study Record Updates

Last Update Posted (Estimate)

May 1, 2009

Last Update Submitted That Met QC Criteria

April 30, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1033IT/0002
  • ITA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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