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

Study at a glance

From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

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.

ClinicalTrials.gov ID

NCT00301457

Acronym / sponsor ID

DATA / D5392NL003

Conditions

Breast Cancer

Keywords

Hormone Sensitive Primary Breast Cancer, Adjuvant Treatment, Aromatase Inhibitor

Phase

Phase 3

Study type

Interventional

Recruitment status

Completed

Enrolment

1,914 participants (actual)

Lead sponsor

Maastricht University Medical CenterUniversity, hospital or other

Study start

Jun 2006 (actual)

Primary completion

Apr 2022 (actual)

Study completion

Apr 2022 (actual)

First posted

13 Mar 2006 (estimated)

Results

Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Treatment

Allocation

Randomised

Intervention model

Parallel groups

Masking

None (open label)

Number of arms

2

Who may qualify

Ages

45 to 99 years

Sex

Female only

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

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

   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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
• Derived from this study: PubMed 36992863Tjan-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.
• Derived from this study: PubMed 30748011van 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.
• Derived from this study: PubMed 30588619van 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.
• Derived from this study: PubMed 29031778Tjan-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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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