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

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1914 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2022-04-30

Brief Summary

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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

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

6 years adjuvant anastrozole therapy

Group Type EXPERIMENTAL

Anastrozole

Intervention Type DRUG

1 mg once daily oral dose

2

3 years adjuvant anastrozole therapy

Group Type EXPERIMENTAL

Anastrozole

Intervention Type DRUG

1 mg once daily oral dose

Interventions

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Anastrozole

1 mg once daily oral dose

Intervention Type DRUG

Other Intervention Names

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ARIMIDEX ZD1033

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

99 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

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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

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Countries

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Netherlands

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.

Reference Type DERIVED
PMID: 36992863 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30748011 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30588619 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29031778 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

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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