Different Durations of Adjuvant Anastrozole Therapy After 2 to 3 Years Tamoxifen Therapy in Breast Cancer (DATA)

February 17, 2023 updated by: Maastricht University Medical Center

A Prospective Randomised, Open, Multicentre, Phase III Study to Assess Different Durations of Anastrozole Therapy After 2 to 3 Years Tamoxifen as Adjuvant Therapy in Postmenopausal Women With Breast Cancer.

The purpose of this study is to determine whether 6 years adjuvant anastrozole will improve the disease free survival compared to 3 years adjuvant anastrozole in postmenopausal hormone sensitive breast cancer patients, subsequent to 2-3 years tamoxifen

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1914

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

  • Netherlands
      • Alkmaar, Netherlands
        • Research Site
      • Almelo, Netherlands
        • Research Site
      • Almere, Netherlands
        • Research Site
      • Amersfoort, Netherlands
        • Research Site
      • Amstelveen, Netherlands
        • Research Site
      • Amsterdam, Netherlands
        • Research Site
      • Apeldoorn, Netherlands
        • Research Site
      • Arnhem, Netherlands
        • Research Site
      • Bergen Op Zoom, Netherlands
        • Research Site
      • Beugen, Netherlands
        • Research Site
      • Breda, Netherlands
        • Research Site
      • Capelle Aan Den IJssel, Netherlands
        • Research Site
      • Den Bosch, Netherlands
        • Research Site
      • Den Haag, Netherlands
        • Research Site
      • Deventer, Netherlands
        • Research Site
      • Dirksland, Netherlands
        • Research Site
      • Doetinchem, Netherlands
        • Research Site
      • Dordrecht, Netherlands
        • Research Site
      • Drachten, Netherlands
        • Research Site
      • Ede, Netherlands
        • Research Site
      • Eindhoven, Netherlands
        • Research Site
      • Emmen, Netherlands
        • Research Site
      • Enschede, Netherlands
        • Research Site
      • Geldrop, Netherlands
        • Research Site
      • Geleen, Netherlands
        • Research Site
      • Goes, Netherlands
        • Research Site
      • Gorinchem, Netherlands
        • Research Site
      • Gouda, Netherlands
        • Research Site
      • Haarlem, Netherlands
        • Research Site
      • Hardenberg, Netherlands
        • Research Site
      • Heerenveen, Netherlands
        • Research Site
      • Heerlen, Netherlands
        • Research Site
      • Hengelo, Netherlands
        • Research Site
      • Hilversum, Netherlands
        • Research Site
      • Hoofddorp, Netherlands
        • Research Site
      • Hoogeveen, Netherlands
        • Research Site
      • Hoorn, Netherlands
        • Research Site
      • Leeuwarden, Netherlands
        • Research Site
      • Leiden, Netherlands
        • Research Site
      • Leidschendam, Netherlands
        • Research Site
      • Maastricht, Netherlands
        • Research Site
      • Nieuwegein, Netherlands
        • Research Site
      • Nijmegen, Netherlands
        • Research Site
      • Purmerend, Netherlands
        • Research Site
      • Roermond, Netherlands
        • Research Site
      • Roosendaal, Netherlands
        • Research Site
      • Rotterdam, Netherlands
        • Research Site
      • Schiedam, Netherlands
        • Research Site
      • Sneek, Netherlands
        • Research Site
      • Spijkenisse, Netherlands
        • Research Site
      • Stadskanaal, Netherlands
        • Research Site
      • Terneuzen, Netherlands
        • Research Site
      • Tiel, Netherlands
        • Research Site
      • Tilburg, Netherlands
        • Research Site
      • Uden, Netherlands
        • Research Site
      • Utrecht, Netherlands
        • Research Site
      • Veldhoven, Netherlands
        • Research Site
      • Venlo, Netherlands
        • Research Site
      • Vlissingen, Netherlands
        • Research Site
      • Winschoten, Netherlands
        • Research Site
      • Winterswijk, Netherlands
        • Research Site
      • Woerden, Netherlands
        • Research Site
      • Zaandam, Netherlands
        • Research Site
      • Zevenaar, Netherlands
        • Research Site
      • Zoetermeer, Netherlands
        • Research Site
      • Zutphen, Netherlands
        • Research Site
      • Zwolle, Netherlands
        • 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

45 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • postmenopausal patients with hormone receptor positive breast cancer who have already received 2 to 3 years of adjuvant tamoxifen, and who never had signs of loco-regional recurrences or distant metastasis

Exclusion Criteria:

  • Previous hormonal therapy as adjuvant breast cancer treatment besides tamoxifen.
  • Previous history of invasive breast cancer within the last 10 years, other then the breast cancer that is currently treated with tamoxifen

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
Experimental: 1
6 years adjuvant anastrozole therapy
Drug: Anastrozole
1 mg once daily oral dose
Other Names:
  • ARIMIDEX
  • ZD1033
Experimental: 2
3 years adjuvant anastrozole therapy
Drug: Anastrozole
1 mg once daily oral dose
Other Names:
  • ARIMIDEX
  • ZD1033

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To assess the disease free survival (DFS) with 6 years of adjuvant anastrozole compared with 3 years of adjuvant anastrozole in postmenopausal hormone sensitive breast cancer patients, subsequent to 2 to 3 years of adjuvant tamoxifen
Time Frame: After 9 years for the group with 6 years of adjuvant anastrozol, subsequent to 2 to 3 years of adjuvant tamoxifen or after 6 years for the group with 3 years of adjuvant anastrozole subsequent to 2 to 3 years of adjuvant tamoxifen
After 9 years for the group with 6 years of adjuvant anastrozol, subsequent to 2 to 3 years of adjuvant tamoxifen or after 6 years for the group with 3 years of adjuvant anastrozole subsequent to 2 to 3 years of adjuvant tamoxifen

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To compare the incidence of contralateral breast cancer after 6 years versus 3 years adjuvant anastrozole, subsequent to 2 to 3 years of tamoxifen
Time Frame: After 9 years for the group with 6 years of adjuvant anastrozol, subsequent to 2 to 3 years of adjuvant tamoxifen or after 6 years for the group with 3 years of adjuvant anastrozole subsequent to 2 to 3 years of adjuvant tamoxifen
After 9 years for the group with 6 years of adjuvant anastrozol, subsequent to 2 to 3 years of adjuvant tamoxifen or after 6 years for the group with 3 years of adjuvant anastrozole subsequent to 2 to 3 years of adjuvant tamoxifen
To compare the overall survival after 6 years versus 3 years adjuvant anastrozole, subsequent to 2 to 3 years of tamoxifen
Time Frame: After 9 years for the group with 6 years of adjuvant anastrozol, subsequent to 2 to 3 years of adjuvant tamoxifen or after 6 years for the group with 3 years of adjuvant anastrozole subsequent to 2 to 3 years of adjuvant tamoxifen
After 9 years for the group with 6 years of adjuvant anastrozol, subsequent to 2 to 3 years of adjuvant tamoxifen or after 6 years for the group with 3 years of adjuvant anastrozole subsequent to 2 to 3 years of adjuvant tamoxifen
To compare toxicity of 6 years versus 3 years of adjuvant anastrozole in postmenopausal hormone sensitive breast cancer patients, subsequent to 2 to 3 years of tamoxifen
Time Frame: After 9 years for the group with 6 years of adjuvant anastrozol, subsequent to 2 to 3 years of adjuvant tamoxifen or after 6 years for the group with 3 years of adjuvant anastrozole subsequent to 2 to 3 years of adjuvant tamoxifen
After 9 years for the group with 6 years of adjuvant anastrozol, subsequent to 2 to 3 years of adjuvant tamoxifen or after 6 years for the group with 3 years of adjuvant anastrozole subsequent to 2 to 3 years of adjuvant tamoxifen
To determine regional differences in the initial treatment of breast cancer retrospectively by collecting baseline information on initial therapies.
Time Frame: After 9 years
Aspects of the initial treatment that will be investigated are e.g. the kind of surgery performed (breast saving or mastectomy) and whether or not chemotherapy is given and which chemotherapy was used in postmenopausal patients in relation to the primary tumour and patient characteristics.
After 9 years
To compare the cost effectiveness of 3 years versus 6 years adjuvant anastrozole therapy, after subsequent 2 to 3 years of adjuvant tamoxifen treatment.
Time Frame: After 9 years for the group with 6 years of adjuvant anastrozol, subsequent to 2 to 3 years of adjuvant tamoxifen or after 6 years for the group with 3 years of adjuvant anastrozole subsequent to 2 to 3 years of adjuvant tamoxifen
After 9 years for the group with 6 years of adjuvant anastrozol, subsequent to 2 to 3 years of adjuvant tamoxifen or after 6 years for the group with 3 years of adjuvant anastrozole subsequent to 2 to 3 years of adjuvant tamoxifen
To assess patterns of care in The Netherlands in prevention, detection and treatment of osteoporosis in postmenopausal women with breast cancer treated with adjuvant anastrozole.
Time Frame: After 9 years
After 9 years
To relate the number of osteoporotic fractures during and following treatment with adjuvant anastrozole with the compliance to osteoporotic guidelines.
Time Frame: After 9 years
After 9 years
To analyse occurrence of distant (bone) metastases in relation to occurrence of osteopenia and osteoporosis, and in relation to use of supplements and therapy for reduced BMD.
Time Frame: After 9 years
After 9 years

Collaborators and Investigators

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

Sponsor

Maastricht University Medical Center

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 (Actual)

June 1, 2006

Primary Completion (Actual)

April 1, 2022

Study Completion (Actual)

April 1, 2022

Study Registration Dates

First Submitted

March 9, 2006

First Submitted That Met QC Criteria

March 9, 2006

First Posted (Estimate)

March 13, 2006

Study Record Updates

Last Update Posted (Estimate)

February 21, 2023

Last Update Submitted That Met QC Criteria

February 17, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D5392NL003
  • EUDRAct No: 2005-006167-31

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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