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

Conditions

Breast Cancer

Keywords

Hormone Sensitive Primary Breast Cancer, Adjuvant Treatment, Aromatase Inhibitor

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

Lammers SWM, Geurts SME, Hermans KEPE, Kooreman LFS, Swinkels ACP, Smorenburg CH, van der Sangen MJC, Kroep JR, Honkoop AH, van den Berkmortel FWPJ, de Roos WK, Linn SC, Imholz ALT, Vriens IJH, Tjan-Heijnen VCG, Dutch Breast Cancer Research Group (BOOG) for the DATA investigators.

2025-02-078 citations

10.1016/j.esmoop.2025.104154

Ovarian function recovery in breast cancer patients receiving adjuvant anastrozole treatment: updated results from the phase 3 DATA trial

S W M Lammers, Sandra M. E. Geurts, Karlijn E. P. E. Hermans, I E G van Hellemond, Astrid C. P. Swinkels et al. (14 authors)

Breast Cancer Research and Treatment2024-06-283 citations

10.1007/s10549-024-07411-w

The prognostic and predictive effect of body mass index in hormone receptor-positive breast cancer

S W M Lammers, Sandra M. E. Geurts, Irene E.G. van Hellemond, Astrid C P Swinkels, Carolien H. Smorenburg et al. (16 authors)

JNCI Cancer Spectrum2023-10-316 citations

10.1093/jncics/pkad092

94MO The prognostic and predictive effect of BMI in postmenopausal HR+ breast cancer patients receiving (extended) endocrine therapy: DATA trial analysis

S.W.M. Lammers, Sandra M. E. Geurts, Irene E.G. van Hellemond, Astrid C P Swinkels, Carolien H. Smorenburg et al. (16 authors)

ESMO Open2023-05-01

10.1016/j.esmoop.2023.101318

Extended adjuvant aromatase inhibition after sequential endocrine therapy in postmenopausal women with breast cancer: follow-up analysis of the randomised phase 3 DATA trial.

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.

2023-03-2011 citations

10.1016/j.eclinm.2023.101901

Abstract P4-14-11: No impact of osteoporosis or bisphosphonate use for osteoporosis on breast cancer outcome: A sub-study of the DATA trial

IE van Hellemond, CH Smorenburg, P.G.M. Peer, AC Swinkels, C Seynaeve et al. (16 authors)

Cancer Research2019-02-151 citations

10.1158/1538-7445.sabcs18-p4-14-11

Efficacy of anastrozole after tamoxifen in early breast cancer patients with chemotherapy‐induced ovarian function failure

Irene E.G. van Hellemond, Ingeborg J. H. Vriens, Petronella G.M. Peer, Astrid C P Swinkels, Carolien H. Smorenburg et al. (17 authors)

International Journal of Cancer2018-12-2712 citations

10.1002/ijc.32093

Assessment and management of bone health in women treated with adjuvant anastrozole in the DATA study.

Irene van Hellemond, Carolien H. Smorenburg, Petronella G.M. Peer, Astrid C P Swinkels, Caroline Seynaeve et al. (16 authors)

Journal of Clinical Oncology2018-05-20

10.1200/jco.2018.36.15_suppl.534

Extended adjuvant aromatase inhibition after sequential endocrine therapy (DATA): a randomised, phase 3 trial.

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.

2017-10-12104 citations

10.1016/s1470-2045(17)30600-9

Anastrozole after tamoxifen in early breast cancer patients with chemotherapy-induced ovarian function failure.

Vivianne C. G. Tjan‐Heijnen, Irene van Hellemond, Ingeborg J. H. Vriens, Petronella G.M. Peer, Astrid C P Swinkels et al. (17 authors)

Journal of Clinical Oncology2017-05-202 citations

10.1200/jco.2017.35.15_suppl.523

Abstract S1-03: First results from the multicenter phase III DATA study comparing 3 versus 6 years of anastrozole after 2-3 years of tamoxifen in postmenopausal women with hormone receptor-positive early breast cancer

VC Tjan-Heijnen, IE van Hellemond, P.G.M. Peer, AC Swinkels, CH Smorenburg et al. (17 authors)

Cancer Research2017-02-1530 citations

10.1158/1538-7445.sabcs16-s1-03

Interventions

DRUGAnastrozole

1 mg once daily oral dose

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

45 Years to 99 Years

Healthy volunteers

No

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

Design outcomes

Primary

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	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

Measure	Time frame	Description
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	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.
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 assess patterns of care in The Netherlands in prevention, detection and treatment of osteoporosis in postmenopausal women with breast cancer treated with adjuvant anastrozole.	After 9 years	—
To relate the number of osteoporotic fractures during and following treatment with adjuvant anastrozole with the compliance to osteoporotic guidelines.	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.	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	—

Countries

Netherlands

Outcome results

None listed