Different Durations of Adjuvant Anastrozole Therapy After 2 to 3 Years Tamoxifen Therapy in Breast Cancer
NCT ID: NCT00301457
Last Updated: 2023-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1914 participants
INTERVENTIONAL
2006-06-30
2022-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
6 years adjuvant anastrozole therapy
Anastrozole
1 mg once daily oral dose
2
3 years adjuvant anastrozole therapy
Anastrozole
1 mg once daily oral dose
Interventions
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Anastrozole
1 mg once daily oral dose
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Previous history of invasive breast cancer within the last 10 years, other then the breast cancer that is currently treated with tamoxifen
45 Years
99 Years
FEMALE
No
Sponsors
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Maastricht University Medical Center
OTHER
Responsible Party
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Principal Investigators
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AstraZeneca Netherlands Medical Director, MD
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
's-Hertogenbosch, , Netherlands
Research Site
Alkmaar, , Netherlands
Research Site
Almelo, , Netherlands
Research Site
Almere Stad, , Netherlands
Research Site
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
Research Site
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
Research Site
Sneek, , Netherlands
Research Site
Spijkenisse, , Netherlands
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Stadskanaal, , Netherlands
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Terneuzen, , Netherlands
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The Hague, , Netherlands
Research Site
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
Research Site
Zoetermeer, , Netherlands
Research Site
Zutphen, , Netherlands
Research Site
Zwolle, , Netherlands
Countries
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References
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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.
van 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.
van 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.
Tjan-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.
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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EUDRAct No: 2005-006167-31
Identifier Type: -
Identifier Source: secondary_id
D5392NL003
Identifier Type: -
Identifier Source: org_study_id
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