Pharmacokinetics of anastrozole and tamoxifen alone, and in combination, during adjuvant endocrine therapy for early breast cancer in postmenopausal women: a sub-protocol of the ‘Arimidex™ and Tamoxifen Alone or in Combination’ (ATAC) trial
2001

Study of Anastrozole and Tamoxifen for Breast Cancer

Sample size: 347 publication Evidence: moderate

Author Information

Author(s): Trialists' Group The ATAC 1

Primary Institution: UCL Cancer Trials Centre, University College London

Hypothesis

How do anastrozole and tamoxifen alone and in combination affect pharmacokinetics in postmenopausal women with early breast cancer?

Conclusion

The reduction in anastrozole levels by tamoxifen is unlikely to be clinically significant when both drugs are used together.

Supporting Evidence

  • The geometric mean anastrozole levels were 27% lower in the presence of tamoxifen than with anastrozole alone.
  • The geometric mean steady-state trough plasma concentrations of tamoxifen and DMT were statistically equivalent in both treatment groups.
  • On-treatment values for oestradiol were below the detection limit in a significant percentage of patients.

Takeaway

This study looked at how two breast cancer medications work together in women. It found that one medicine doesn't really change how the other works.

Methodology

The study used a randomized, double-blind design and measured plasma concentrations of the drugs in patients who had been compliant with their medication.

Participant Demographics

Postmenopausal women with early breast cancer

Statistical Information

P-Value

< 0.001

Confidence Interval

90% Cl 20–33%

Statistical Significance

p<0.001

Digital Object Identifier (DOI)

10.1054/bjoc.2001.1925

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