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Breast density changes in a randomized controlled trial evaluating bazedoxifene/conjugated estrogens.

Jennifer A Harvey1, JoAnn V Pinkerton, Edmund C Baracat

  • 1Department of Radiology, University of Virginia Health System, Charlottesville, VA 22908, USA. JAH7W@virginia.edu

Menopause (New York, N.Y.)
|December 29, 2012
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Summary

Bazedoxifene/conjugated estrogens (BZA/CE) did not significantly alter mammographic breast density in postmenopausal women over 24 months. This finding is crucial for understanding the safety profile of hormone therapy concerning breast cancer risk factors.

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Area of Science:

  • Endocrinology
  • Oncology
  • Radiology

Background:

  • Mammographic breast density is a known risk factor for breast cancer.
  • Postmenopausal hormone therapy can influence breast tissue composition.
  • Understanding the impact of treatments like bazedoxifene/conjugated estrogens (BZA/CE) on breast density is vital for assessing breast cancer risk.

Purpose of the Study:

  • To evaluate the effect of 24-month treatment with BZA/CE on mammographic breast density in postmenopausal women.
  • To compare the changes in breast density among different BZA/CE dosages, raloxifene, and placebo.

Main Methods:

  • An ancillary study involving nonhysterectomized postmenopausal women from a phase 3 trial.
  • Mammograms were analyzed at baseline and 24 months using validated software by a blinded radiologist.
  • Evaluated treatments included BZA 20 mg/CE 0.45 mg, BZA 20 mg/CE 0.625 mg, raloxifene 60 mg, and placebo.

Main Results:

  • No significant changes in mean mammographic breast density were observed across BZA/CE, raloxifene, and placebo groups after 24 months.
  • Statistically significant reductions in breast density from baseline were noted for the BZA 20 mg/CE 0.45 mg and placebo groups.
  • The effects on breast density were consistent across subgroups defined by age, BMI, and years since menopause.

Conclusions:

  • Treatment with BZA 20 mg/CE 0.45 mg or BZA 20 mg/CE 0.625 mg for 24 months did not adversely affect mammographic breast density.
  • These findings suggest that BZA/CE therapy does not increase breast density, a potential surrogate marker for breast cancer risk.