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

Menopause

Volumn 20, Issue 2, 2013, Pages 138-145

  Harvey, Jennifer A ^a   Pinkerton, Joann V ^b   Baracat, Edmund C ^c   Shi, Harry ^d   Chines, Arkadi A ^d   Mirkin, Sebastian ^d  

^a UNIVERSITY OF VIRGINIA   (United States)

^b UNIVERSITY OF VIRGINIA HEALTH SYSTEM   (United States)

^c UNIVERSITY OF SÃO PAULO   (Brazil)

^d PFIZER INC   (United States)

Author keywords

Bazedoxifene; Breast density; Conjugated estrogens; Mammography; Menopause; Tissue selective estrogen complex

Indexed keywords

BAZEDOXIFENE; CONJUGATED ESTROGEN; PLACEBO; RALOXIFENE;

ADULT; AGE; AGED; ARTICLE; BODY MASS; BREAST; COMPUTER PROGRAM; CONTROLLED STUDY; DENSITY; FEMALE; HUMAN; MAMMOGRAPHY; MENOPAUSE; PHASE 3 CLINICAL TRIAL; POSTMENOPAUSE; RADIOLOGIST; RANDOMIZED CONTROLLED TRIAL;

BREAST; BREAST NEOPLASMS; DOUBLE-BLIND METHOD; ESTROGENS, CONJUGATED (USP); FEMALE; HUMANS; INDOLES; MAMMARY GLANDS, HUMAN; MAMMOGRAPHY; MIDDLE AGED; PLACEBOS; POSTMENOPAUSE; SELECTIVE ESTROGEN RECEPTOR MODULATORS;

EID: 84873407467     PISSN: 10723714     EISSN: 15300374     Source Type: Journal    
DOI: 10.1097/gme.0b013e318271f5e7     Document Type: Article

References (45)

1. Boyd NF, Rommens JM, Vogt K, Lee V, Hopper JL, Yaffe MJ, et al. Mammographic breast density as an intermediate phenotype for breast cancer. Lancet Oncol 2005;6:798-808.
2. Heusinger K, Loehberg CR, Haeberle L, Jud SM, Klingsiek P, Hein A, et al. Mammographic density as a risk factor for breast cancer in a German case-control study. Eur J Cancer Prev 2011;20:1-8.
3. McCormack VA, dos Santos Silva I. Breast density and parenchymal patterns as markers of breast cancer risk: a meta-analysis. Cancer Epidemiol Biomarkers Prev 2006;15:1159-1169.
4. Ursin G, Ma H, Wu AH, Bernstein L, Salane M, Parisky YR, et al. Mammographic density and breast cancer in three ethnic groups. Cancer Epidemiol Biomarkers Prev 2003;12:332-338.
5. Mandelson MT, Oestreicher N, Porter PL, White D, Finder CA, Taplin SH, et al. Breast density as a predictor of mammographic detection: comparison of interval-and screen-detected cancers. J Natl Cancer Inst 2000;92:1081-1087.
6. Pinsky RW, Helvie MA. Mammographic breast density: effect on imaging and breast cancer risk. J Natl Compr Cancer Netw 2010;8: 1157-1164.
7. Topal NB, Ayhan S, Topal U, Bilgin T. Effects of hormone replacement therapy regimens on mammographic breast density: the role of progestins. J Obstet Gynaecol Res 2006;32:305-308.
8. Santen R. Menopausal hormone therapies: their effect on mammographic density and breast cancer risk. Gynecol Endocrinol 2005;21:12-16.
9. Sterns EE, Zee B. Mammographic density changes in perimenopausal and postmenopausal women: is effect of hormone replacement therapy predictable? Breast Cancer Res Treat 2000;59:125-132.
10. Harvey JA, Pinkerton JV, Herman CR. Short-term cessation of hormone replacement therapy and improvement of mammographic specificity. J Natl Cancer Inst 1997;89:1623-1625.
11. Kaewrudee S, Anuwutnavin S, Kanpittaya J, Soontrapa S, Sakondhavat C. Effect of estrogen-progestin and estrogen on mammographic density. J Reprod Med 2007;52:513-520.
12. Chen FP, Cheung YC, Soong YK. Factors that influence changes in mammographic density with postmenopausal hormone therapy. Taiwan J Obstet Gynecol 2010;49:413-418.
13. Jackson VP, San Martin JA, Secrest RJ, McNabb M, Carranza-Lira S, Figuero-Casas P, et al. Comparison of the effect of raloxifene and continuous-combined hormone therapy on mammographic breast density and breast tenderness in postmenopausal women. Am J Obstet Gynecol 2003;188:389-394.
14. Harvey JA, Holm MK, Ranganath R, Guse PA, Trott EA, Helzner E. The effects of bazedoxifene on mammographic breast density in postmenopausal women with osteoporosis. Menopause 2009;16:1193-1196.
15. Atkinson C, Warren R, Bingham SA, Day NE. Mammographic patterns as a predictive biomarker of breast cancer risk: effect of tamoxifen. Cancer Epidemiol Biomarkers Prev 1999;8:863-866.
16. Chow CK, Venzon D, Jones EC, Premkumar A, O'Shaughnessy J, Zujewski J. Effect of tamoxifen on mammographic density. Cancer Epidemiol Biomarkers Prev 2000;9:917-921.
17. Freedman M, San Martin J, O'Gorman J, Eckert S, Lippman ME, Lo SCB, et al. Digitized mammography: a clinical trial of postmenopausal women randomly assigned to receive raloxifene, estrogen, or placebo. J Natl Cancer Inst 2001;93:51-56.
18. Lasco A, Gaudio A, Morini E, Morabito N, Nicita-Mauro C, Catalano A, et al. Effect of long-term treatment with raloxifene on mammary density in postmenopausal women. Menopause 2006;13:787-792.
19. Cuzick J, Forbes JF, Sestak I, Cawthorn S, Hamed H, Holli K, et al. Long-term results of tamoxifen prophylaxis for breast cancerV96-month follow-up of the randomized IBIS-I trial. J Natl Cancer Inst 2007;99:272-282.
20. Cuzick J, Warwick J, Pinney E, Duffy SW, Cawthorn S, Howell A, et al. Tamoxifen-induced reduction in mammographic density and breast cancer risk reduction: a nested case-control study. J Natl Cancer Inst 2011;103:744-752.
21. Kharode Y, Bodine PV, Miller CP, Lyttle CR, Komm BS. The pairing of a selective estrogen receptor modulator, bazedoxifene, with conjugated estrogens as a new paradigm for the treatment of menopausal symptoms and osteoporosis prevention. Endocrinology 2008;149:6084-6091.
22. Berrodin TJ, Chang KC, Komm BS, Freedman LP, Nagpal S. Differential biochemical and cellular actions of Premarin estrogens: distinct pharmacology of bazedoxifene-conjugated estrogens combination. Mol Endocrinol 2009;23:75-85.
23. Lindsay R, Gallagher JC, Kagan R, Pickar JH, Constantine G. Efficacy of tissue-selective estrogen complex of bazedoxifene/conjugated estrogens for osteoporosis prevention in at-risk postmenopausal women. Fertil Steril 2009;92:1045-1052.
24. Lobo RA, Pinkerton JV, Gass ML, Dorin MH, Ronkin S, Pickar JH, et al. Evaluation of bazedoxifene/conjugated estrogens for the treatment of menopausal symptoms and effects on metabolic parameters and overall safety profile. Fertil Steril 2009;92:1025-1038.
25. Pinkerton JV, Utian WH, Constantine GD, Olivier S, Pickar JH. Relief of vasomotor symptoms with the tissue-selective estrogen complex containing bazedoxifene/conjugated estrogens: a randomized, controlled trial. Menopause 2009;16:1116-1124.
26. Kagan R, Williams RS, Pan K, Mirkin S, Pickar JH. A randomized, placebo-and active-controlled trial of bazedoxifene/conjugated estrogens for treatment of moderate to severe vulvar/vaginal atrophy in postmenopausal women. Menopause 2010;17:281-289.
27. Pickar JH, Yeh I-T, Bachmann G, Speroff L. Endometrial effects of a tissue selective estrogen complex containing bazedoxifene/conjugated estrogens as a menopausal therapy. Fertil Steril 2009;92:1018-1024.
28. Pinkerton JV, Taylor H, Pan K, Chines A, Mirkin S. Breast parameters with bazedoxifene/conjugated estrogens in randomized, controlled trials of postmenopausal women. Menopause 2010;17:1221-1222. Abstract S-21.
29. Pinkerton JA, Constantine GD, Komm BS, Yu H, Pickar JH. Breast effects of bazedoxifene/conjugated estrogens in a randomized, controlled trial of postmenopausal women. Menopause 2008;15:1221. Abstract P-46.
30. Archer DF, Lewis V, Carr BR, Olivier S, Pickar JH. Bazedoxifene/ conjugated estrogens (BZA/CE): incidence of uterine bleeding in postmenopausal women. Fertil Steril 2009;92:1039-1044.
31. Byng JW, Yaffe MJ, Jong RA, Shumak RS, Lockwood GA, Tritchler DL, et al. Analysis of mammographic density and breast cancer risk from digitized mammograms. Radiographics 1998;18:1587-1598.
32. Boyd NF, Byng JW, Jong RA, Fishell EK, Little LE, Miller AB, et al. Quantitative classification of mammographic densities and breast cancer risk: results from the Canadian National Breast Screening Study. J Natl Cancer Inst 1995;87:670-675.
33. The North American Menopause Society. Estrogen and progestogen use in postmenopausal women: 2010 position statement of The North American Menopause Society. Menopause 2010;17:242-255.
34. Rossouw JE, Anderson GL, Prentice RL, LaCroix AZ, Kooperberg C, Stefanick ML, et al. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Womens Health Initiative randomized controlled trial. JAMA 2002;288:321-333.
35. Chlebowski RT, Hendrix SL, Langer RD, Stefanick ML, Gass M, Lane D, et al. Influence of estrogen plus progestin on breast cancer and mammography in healthy postmenopausal women: the Womens Health Initiative randomized trial. JAMA 2003;289:3243-3253.
36. McNicholas MM, Heneghan JP, Milner MH, Tunney T, Hourihane JB, MacErlaine DP. Pain and increased mammographic density in women receiving hormone replacement therapy: a prospective study. AJR Am J Roentgenol 1994;163:311-315.
37. Yaghjyan L, Colditz GA, Collins LC, Schnitt SJ, Rosner B, Vachon C, et al. Mammographic breast density and subsequent risk of breast cancer in postmenopausal women according to tumor characteristics. J Natl Cancer Inst 2011;103:1-11.
38. Kelemen LE, Pankratz VS, Sellers TA, Brandt KR, Wang A, Janney C, et al. Age-specific trends in mammographic density: the Minnesota Breast Cancer Family Study. Am J Epidemiol 2008;167:1027-1036.
39. Peano BJ, Crabtree JS, Komm BS, Winneker RC, Harris HA. Effects of various selective estrogen receptor modulators with or without conjugated estrogens on mouse mammary gland. Endocrinology 2009;150: 1897-1903.
40. Chang KCN, Wang Y, Bodine PV, Nagpal S, Komm BS. Gene expression profiling studies of three SERMs and their conjugated estrogen combinations in human breast cancer cells: insights into the unique antagonistic effects of bazedoxifene on conjugated estrogens. J Steroid Biochem Mol Biol 2010;118:117-124.
41. Martin LJ, Minkin S, Boyd NF. Hormone therapy, mammographic density, and breast cancer risk. Maturitas 2009;64:20-26.
42. McTiernan A, Martin CF, Peck JD, Aragaki AK, Chlebowski RT, Pisano ED, et al. Estrogen-plus-progestin use and mammographic density in postmenopausal women: Womens Health Initiative randomized trial. J Natl Cancer Inst 2005;97:1366-1376.
43. Chiarelli AM, Kirsh VA, Klar NS, Shumak R, Jong R, Fishell E, et al. Influence of patterns of hormone replacement therapy use and mammographic density on breast cancer detection. Cancer Epidemiol Biomarkers Prev 2006;15:1856-1862.
44. Boyd NF,Melnichouk O, Martin LJ, Hislop G, Chiarelli AM, Yaffe MJ, et al. Mammographic density, response to hormones, and breast cancer risk. J Clin Oncol 2011;29:2985-2992.
45. Pearman L, Kagan R, Arsenault J, Muram D. The effects of raloxifene on mammographic breast density: a review of clinical trials. Menopause 2010;17:654-659.