PROACT - Pre-Operative Arimidex Compared To Tamoxifen

February 2, 2010 updated by: AstraZeneca

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.

The purpose of this study is to compare tamoxifen, versus a newer treatment, ARIMIDEX, which we already know to be well tolerated. The main objectives of this research study are to see whether using these drugs will shrink down tumours before surgery and to see if any shrinkage in the tumour affects the extent of surgery that is required.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

452

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

  • Belgium
      • Antwerpen, Belgium
        • Research Site
      • Hasselt, Belgium
        • Research Site
      • Leuven, Belgium
        • Research Site
      • Liege, Belgium
        • Research Site
  • Brazil
      • Fortaleza, Brazil
        • Research Site
      • Porto Alegre, Brazil
        • Research Site
      • Sheffield, Brazil
        • Research Site
    • RJ
      • Rio de Janeiro, RJ, Brazil
        • Research Site
    • RS
      • Porto Alegre, RS, Brazil
        • Research Site
    • SP
      • São Paulo, SP, Brazil
        • Research Site
  • Canada
      • Quebec, Canada
        • Research Site
    • Alberta
      • Edmonton, Alberta, Canada
        • Research Site
    • Ontario
      • Newmarket, Ontario, Canada
        • Research Site
    • Quebec
      • Chicoutimi, Quebec, Canada
        • Research Site
      • Montreal, Quebec, Canada
        • Research Site
  • Czech Republic
      • Brno, Czech Republic
        • Research Site
      • Nova Ves Pod Plesi, Czech Republic
        • Research Site
      • Olomouc, Czech Republic
        • Research Site
      • Peské Budjovice, Czech Republic
        • Research Site
      • Praha 2, Czech Republic
        • Research Site
      • Praha-5, Czech Republic
        • Research Site
  • France
      • Avignon, France
        • Research Site
      • Dijon, France
        • Research Site
      • Limoges, France
        • Research Site
      • Lyon, France
        • Research Site
      • Marseille, France
        • Research Site
      • Montpellier Cedex 5, France
        • Research Site
      • Nice Cedex, France
        • Research Site
      • Paris, France
        • Research Site
      • Tours Cedex, France
        • Research Site
    • Cedex 08
      • Lyon, Cedex 08, France
        • Research Site
  • Hungary
      • Budapest, Hungary
        • Research Site
      • Gyor, Hungary
        • Research Site
      • Kecskemet, Hungary
        • Research Site
      • Szeged, Hungary
        • Research Site
      • Szolnok, Hungary
        • Research Site
  • Italy
    • BO
      • Bologna, BO, Italy
        • Research Site
    • CA
      • Cagliari, CA, Italy
        • Research Site
      • Monserrato, CA, Italy
        • Research Site
    • Chiba
      • Kashiwa, Chiba, Italy
        • Research Site
    • FI
      • Firenze, FI, Italy
        • Research Site
    • GE
      • Genova, GE, Italy
        • Research Site
    • PA
      • Palermo, PA, Italy
        • Research Site
    • RE
      • Reggio Emilia, RE, Italy
        • Research Site
  • Japan
      • Chiba, Japan
        • Research Site
      • Fukuoka, Japan
        • Research Site
      • Kumamoto, Japan
        • Research Site
      • Niigata, Japan
        • Research Site
      • Oita, Japan
        • Research Site
      • Osaka, Japan
        • Research Site
    • Aichi
      • Nagoya, Aichi, Japan
        • Research Site
    • Ehime
      • Matsuyama, Ehime, Japan
        • Research Site
    • Fukuoka
      • Kitakyusyu, Fukuoka, Japan
        • Research Site
    • Gunma
      • Ota, Gunma, Japan
        • Research Site
    • Hiroshima
      • Fukuyama, Hiroshima, Japan
        • Research Site
    • Hokkaido
      • Sapporo, Hokkaido, Japan
        • Research Site
    • Hyogo
      • Amagasaki, Hyogo, Japan
        • Research Site
    • Kanagawa
      • Isehara, Kanagawa, Japan
        • Research Site
      • Yokohama, Kanagawa, Japan
        • Research Site
    • Osaka
      • Osakasayama, Osaka, Japan
        • Research Site
      • Suita, Osaka, Japan
        • Research Site
    • Saitama
      • Kitaadachi, Saitama, Japan
        • Research Site
    • Tokyo
      • Chuo, Tokyo, Japan
        • Research Site
  • Netherlands
      • Den Haag, Netherlands
        • Research Site
      • Nijmegen, Netherlands
        • Research Site
      • Sittard, Netherlands
        • Research Site
  • United States
    • California
      • Santa Rosa, California, United States
        • Research Site
    • Connecticut
      • New Britain, Connecticut, United States
        • Research Site
      • Torrington, Connecticut, United States
        • Research Site
    • Illinois
      • Springfield, Illinois, United States
        • Research Site
    • Iowa
      • Mason City, Iowa, United States
        • Research Site
    • Louisiana
      • Baton Rouge, Louisiana, United States
        • Research Site
    • Massachusetts
      • Pittsfield, Massachusetts, United States
        • Research Site
    • Missouri
      • St. Louis, Missouri, United States
        • Research Site
    • New Mexico
      • Albuquerque, New Mexico, United States
        • Research Site
    • Oregon
      • Portland, Oregon, United States
        • Research Site
    • Texas
      • Austin, Texas, United States
        • Research Site
      • Houston, Texas, United States
        • Research Site
    • Washington
      • Olympia, Washington, United States
        • 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

58 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Operable or potentially operable breast cancer
  • Invasive breast cancer proven to be hormone-sensitive (ER+/PR+)
  • Patients who might benefit from endocrine treatment prior to surgery
  • Postmenopausal
  • Signed written informed consent

Exclusion Criteria:

  • Inoperable breast cancer
  • Patient unwilling to undergo surgery
  • Any reason why the patient may not be able to conform to study requirements
  • Any previous treatment for breast cancer
  • Previous Tamoxifen use as a part of breast cancer prevention trials
  • Not willing to stop taking drugs that affect sex-hormones such as HRT
  • Previous history of breast cancer
  • Previous history of invasive malignancy within the last 10 years
  • Any other severe disease that may prevent surgery, place the patient at risk, or influence the study results
  • Treatment with an experimental drug within the last 3 months
  • Risk of transmitting HIV, Hepatitis B or C

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: Triple

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Objective tumour response
Time Frame: Assessed at 3 months
Assessed at 3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Pathological response
Time Frame: Assessed at 3 months
Assessed at 3 months
Extent of breast surgery
Time Frame: Assessed at 3 months
Assessed at 3 months
Extent of axillary down-staging
Time Frame: Assessed at 3 months
Assessed at 3 months
Clinical ultrasound response versus clinical caliper response
Time Frame: Assessed at 3 months
Assessed at 3 months
Safety
Time Frame: Assessed up to 5 years + 30 days
Assessed up to 5 years + 30 days
Complications due to surgery
Time Frame: Assessed up to 30 days post-surgery
Assessed up to 30 days post-surgery
Health economics outcomes
Time Frame: Assessed up to 30 days post-surgery
Assessed up to 30 days post-surgery
Quality of Life assessments
Time Frame: Assessed at 3 months
Assessed at 3 months
Effect of ethnicity with respect to baseline patient and tumour characteristics, safety and objective tumour response rate
Time Frame: Assessed up to 5 years + 30 days
Assessed up to 5 years + 30 days
Recurrence-free survival and survival
Time Frame: Assessed up to 5 years
Assessed up to 5 years

Collaborators and Investigators

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

Sponsor

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

August 1, 2000

Primary Completion (Actual)

January 1, 2003

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

September 30, 2005

First Submitted That Met QC Criteria

September 30, 2005

First Posted (Estimate)

October 5, 2005

Study Record Updates

Last Update Posted (Estimate)

February 3, 2010

Last Update Submitted That Met QC Criteria

February 2, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1033IL/0039
  • D5395C00039

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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