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Gene amplification of  CCND1  is observed in a subgroup of breast cancers with poor prognosis, whereas overexpression of the protein cyclin D 1  has been linked to both worse and better clinical outcome.  CCND1  amplification and protein overexpression have also been associated with resistance to treatment with tamoxifen or even to a potentially detrimental effect of tamoxifen.    Methods  To clarify these challenging and partly contrasting treatment predictive and prognostic links for cyclin D 1  we analysed a large cohort of postmenopausal breast cancer patients randomised to receive either adjuvant anastrozole or tamoxifen, as part of the Arimidex, Tamoxifen, Alone or in Combination (ATAC) trial. The  CCND1  amplification status and protein expression of cyclin D 1  were assessed by chromogenic  in situ  hybridisation and immunohistochemistry, respectively, in 1,155 postmenopausal, oestrogen-receptor-positive breast cancer patients included in the TransATAC substudy.    Results  Amplification of  CCND1  was observed in 8.7% of the tumours and was associated with increased risk of disease recurrence (hazard ratio = 1.61; 95% confidence interval, 1.08 to 2.41) after adjustment for other clinicopathological parameters. In contrast, nuclear expression of cyclin D 1  protein was associated with decreased recurrence rate (hazard ratio = 0.6; 95% confidence interval, 0.39 to 0.92). The intensity of nuclear or cytoplasmic expression was not of prognostic value. There was no significant interaction between cyclin D 1  status and treatment efficacy, ruling out any major detrimental effect of tamoxifen in  CCND1 -amplified postmenopausal breast cancer.    Conclusions  In summary,  CCND1  amplification and low nuclear expression of cyclin D 1  predicted poor clinical outcome in postmenopausal breast cancer patients treated with either anastrozole or tamoxifen.    Trial Registration  Current Controlled Trials  ISRCTN18233230 .

breast cancer research

Effects of cyclin D1 gene amplification and protein expression on time to recurrence in postmenopausal breast cancer patients treated with anastrozole or tamoxifen: a TransATAC study