Different Durations of Adjuvant Anastrozole Therapy After 2 to 3 Years Tamoxifen Therapy in Breast Cancer
DATA
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.
2 other identifiers
interventional
1,914
1 country
67
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 breast-cancer
Started Jun 2006
Longer than P75 for phase_3 breast-cancer
67 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 9, 2006
CompletedFirst Posted
Study publicly available on registry
March 13, 2006
CompletedStudy Start
First participant enrolled
June 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2022
CompletedFebruary 21, 2023
February 1, 2023
15.8 years
March 9, 2006
February 17, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
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 Outcomes (8)
To compare the incidence of contralateral breast cancer after 6 years versus 3 years adjuvant anastrozole, subsequent to 2 to 3 years of 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
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
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.
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.
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
- +3 more secondary outcomes
Study Arms (2)
1
EXPERIMENTAL6 years adjuvant anastrozole therapy
2
EXPERIMENTAL3 years adjuvant anastrozole therapy
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (67)
Research Site
's-Hertogenbosch, Netherlands
Research Site
Alkmaar, Netherlands
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Almelo, Netherlands
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Almere Stad, Netherlands
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Amersfoort, Netherlands
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Amstelveen, Netherlands
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Amsterdam, Netherlands
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Apeldoorn, Netherlands
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Arnhem, Netherlands
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Bergen op Zoom, Netherlands
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Beugen, Netherlands
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Breda, Netherlands
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Capelle aan den IJssel, Netherlands
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Deventer, Netherlands
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Dirksland, Netherlands
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Doetinchem, Netherlands
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Dordrecht, Netherlands
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Drachten, Netherlands
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Ede, Netherlands
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Eindhoven, Netherlands
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Emmen, Netherlands
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Enschede, Netherlands
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Flushing, Netherlands
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Geldrop, Netherlands
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Geleen, Netherlands
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Goes, Netherlands
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Gorinchem, Netherlands
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Gouda, Netherlands
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Haarlem, Netherlands
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Hardenberg, Netherlands
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Heerenveen, Netherlands
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Heerlen, Netherlands
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Hengelo, Netherlands
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Hilversum, Netherlands
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Hoofddorp, Netherlands
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Hoogeveen, Netherlands
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Hoorn, Netherlands
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Leeuwarden, Netherlands
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Leiden, Netherlands
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Leidschendam, Netherlands
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Maastricht, Netherlands
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Nieuwegein, Netherlands
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Nijmegen, Netherlands
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Purmerend, Netherlands
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Roermond, Netherlands
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Roosendaal, Netherlands
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Rotterdam, Netherlands
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Schiedam, Netherlands
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Sneek, Netherlands
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Spijkenisse, Netherlands
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Stadskanaal, Netherlands
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Terneuzen, Netherlands
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The Hague, Netherlands
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Tiel, Netherlands
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Tilburg, Netherlands
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Uden, Netherlands
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Utrecht, Netherlands
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Veldhoven, Netherlands
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Venlo, Netherlands
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Winschoten, Netherlands
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Winterswijk, Netherlands
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Woerden, Netherlands
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Zaandam, Netherlands
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Zevenaar, Netherlands
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Zoetermeer, Netherlands
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Zutphen, Netherlands
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Zwolle, Netherlands
Related Publications (4)
Tjan-Heijnen VCG, Lammers SWM, Geurts SME, Vriens IJH, Swinkels ACP, Smorenburg CH, van der Sangen MJC, Kroep JR, de Graaf H, Honkoop AH, Erdkamp FLG, de Roos WK, Linn SC, Imholz ALT; Dutch Breast Cancer Research Group (BOOG) for the DATA Investigators. Extended adjuvant aromatase inhibition after sequential endocrine therapy in postmenopausal women with breast cancer: follow-up analysis of the randomised phase 3 DATA trial. EClinicalMedicine. 2023 Mar 20;58:101901. doi: 10.1016/j.eclinm.2023.101901. eCollection 2023 Apr.
PMID: 36992863DERIVEDvan Hellemond IEG, Smorenburg CH, Peer PGM, Swinkels ACP, Seynaeve CM, van der Sangen MJC, Kroep JR, de Graaf H, Honkoop AH, Erdkamp FLG, van den Berkmortel FWPJ, de Boer M, de Roos WK, Linn SC, Imholz ALT, Tjan-Heijnen VCG; Dutch Breast Cancer Research Group (BOOG). Assessment and management of bone health in women with early breast cancer receiving endocrine treatment in the DATA study. Int J Cancer. 2019 Sep 1;145(5):1325-1333. doi: 10.1002/ijc.32205. Epub 2019 Mar 4.
PMID: 30748011DERIVEDvan Hellemond IEG, Vriens IJH, Peer PGM, Swinkels ACP, Smorenburg CH, Seynaeve CM, van der Sangen MJC, Kroep JR, de Graaf H, Honkoop AH, Erdkamp FLG, van den Berkmortel FWPJ, de Boer M, de Roos WK, Linn SC, Imholz ALT, Tjan-Heijnen VCG; Dutch Breast Cancer Research Group (BOOG). Efficacy of anastrozole after tamoxifen in early breast cancer patients with chemotherapy-induced ovarian function failure. Int J Cancer. 2019 Jul 1;145(1):274-283. doi: 10.1002/ijc.32093. Epub 2019 Jan 16.
PMID: 30588619DERIVEDTjan-Heijnen VCG, van Hellemond IEG, Peer PGM, Swinkels ACP, Smorenburg CH, van der Sangen MJC, Kroep JR, De Graaf H, Honkoop AH, Erdkamp FLG, van den Berkmortel FWPJ, de Boer M, de Roos WK, Linn SC, Imholz ALT, Seynaeve CM; Dutch Breast Cancer Research Group (BOOG) for the DATA Investigators. Extended adjuvant aromatase inhibition after sequential endocrine therapy (DATA): a randomised, phase 3 trial. Lancet Oncol. 2017 Nov;18(11):1502-1511. doi: 10.1016/S1470-2045(17)30600-9. Epub 2017 Oct 12.
PMID: 29031778DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AstraZeneca Netherlands Medical Director, MD
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 9, 2006
First Posted
March 13, 2006
Study Start
June 1, 2006
Primary Completion
April 1, 2022
Study Completion
April 1, 2022
Last Updated
February 21, 2023
Record last verified: 2023-02