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Breast tenderness after initiation of conjugated equine estrogens and mammographic density change

Breast Cancer Research and Treatment volume 131, pages 969–979 (2012)Cite this article

Abstract

We examined the association between new-onset breast tenderness and change in mammographic density after initiation of conjugated equine estrogens (CEE). We analyzed baseline, year 1 and 2 data from 695 participants of the Women’s Health Initiative Estrogen + Progestin (daily CEE 0.625 mg + medroxyprogesterone acetate 2.5 mg [MPA] or placebo) and Estrogen-Alone (CEE 0.625 mg or placebo) trials who participated in the Mammogram Density Ancillary Study. Using multivariable repeated measures models, we analyzed the association between new-onset breast tenderness (i.e. absence of baseline tenderness and presence of tenderness at year 1 follow-up) and change from baseline in percent mammographic density. Active therapy increased the odds of new-onset breast tenderness (CEE + MPA vs. placebo risk ratio [RR] 3.01, 95% confidence interval [95% CI] 1.96–4.62; CEE vs. placebo RR 1.70, 95% CI 1.14–2.53). Among women assigned to CEE + MPA, mean increase in mammographic density was greater among participants reporting new-onset of breast tenderness than among participants without new-onset breast tenderness (11.3 vs. 3.9% at year 1, 9.4 vs. 3.2% at year 2, P < 0.001). Among women assigned to CEE alone, increase in mammographic density at year 1 follow-up was not significantly different in women with new-onset breast tenderness compared to women without new-onset breast tenderness (2.4 vs. 0.6% at year 1, 2.2 vs. 1.0% at year 2, P = 0.30). The new-onset of breast tenderness after initiation of CEE + MPA, but not CEE alone, is associated with greater increases in mammographic density.

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Acknowledgments

The WHI program is funded by the National Heart, Lung, and Blood Institute, National Institutes of Health, U.S. Department of Health and Human Services through contracts N01WH22110, 24152, 32100-2, 32105-6, 32108-9, 32111-13, 32115, 32118-32119, 32122, 42107-26, 42129-32, and 44221. The active study drug and placebo were supplied by Wyeth-Ayerst Research Laboratories, Philadelphia, Pennsylvania. Dr. Crandall’s work was supported by the Eileen Ogle Award of the Iris Cantor-UCLA Women’s Health Center. The authors thank the women who generously participated in the WHI Trial. We are grateful to the WHI investigators and staff for their dedicated efforts.

Conflict of interest

AM: Consultant or advisory relationships—Novartis, Proctor and Gamble, Merck, Metagenics, Zymogenetic; Stock ownership—Merck; Honoraria—Wyeth, Novartis; Research funding—Wyeth. GA: Expert testimony on behalf of Fred Hutchinson Cancer Research Center. RC: Consultant or advisory relationships—Novartis, Pfizer, Astra Zeneca; Honoraria—Novartis, Astra Zeneca; Research funding—Amgen. CC, AA, JC, JM, JM-W have no conflicts of interest to declare.

Author information

Affiliations

  1. Department of Medicine, David Geffen School of Medicine at University of California, UCLA Medicine/GIM, 911 Broxton Ave., 1st Floor, Los Angeles, CA, 90024, USA

    Carolyn J. Crandall

  2. WHI Clinical Coordinating Center, Fred Hutchinson Cancer Research Center, Seattle, WA, USA

    Aaron K. Aragaki

  3. Department of Epidemiology, University of Pittsburgh, Pittsburgh, PA, USA

    Jane A. Cauley

  4. Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA, USA

    Anne McTiernan

  5. Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA

    JoAnn E. Manson

  6. Division of Public Health Services, Fred Hutchinson Cancer Research Center, Seattle, Washington

    Garnet L. Anderson

  7. University at Buffalo, Buffalo, NY, USA

    Jean Wactawski-Wende

  8. Department of Hematology and Oncology, Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Los Angeles, CA, USA

    Rowan T. Chlebowski

Authors
  1. Carolyn J. Crandall
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  2. Aaron K. Aragaki
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  3. Jane A. Cauley
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  4. Anne McTiernan
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  5. JoAnn E. Manson
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  6. Garnet L. Anderson
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  7. Jean Wactawski-Wende
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  8. Rowan T. Chlebowski
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Corresponding author

Correspondence to Carolyn J. Crandall.

Appendix

Appendix

The WHI investigators

Program Office (National Heart, Lung, and Blood Institute, Bethesda, Maryland). Jacques Rossouw, Shari Ludlam, Joan McGowan, Nancy Geller, Leslie Ford.

Clinical Coordinating Center (Fred Hutchinson Cancer Research Center, Seattle, WA). Garnet Anderson, Ross Prentice, Andrea LaCroix, Charles Kooperberg, Barbara Cochrane, Julie Hunt, Marian Neuhouser, Lesley Tinker, Susan Heckbert, Alex Reiner.

Regional Centers (Brigham and Women’s Hospital, Harvard Medical School, Boston, MA) JoAnn E. Manson, Kathryn M. Rexrode, Brian Walsh, J. Michael Gaziano, Maria Bueche; (MedStar Health Research Institute/Howard University, Washington, DC) Barbara V. Howard, Lucile Adams-Campbell, Lawrence Lessin, Cheryl Iglesia, Brian Walitt, Amy Park; (The Ohio State University, Columbus, OH) Rebecca Jackson, Randall Harris, Electra Paskett, W. Jerry Mysiw, Michael Blumenfeld; (Stanford Prevention Research Center, Stanford, CA) Marcia L. Stefanick, Mark A. Hlatky, Bertha Chen, Randall S. Stafford, Sally Mackey; (University of Arizona, Tucson/Phoenix, AZ) Cynthia A. Thomson, Tamsen Bassford, Cheryl Ritenbaugh, Zhao Chen, Marcia Ko; (University at Buffalo, Buffalo, NY) Jean Wactawski-Wende, Maurizio Trevisan, Ellen Smit, Amy Millen, Michael LaMonte; (University of Florida, Gainesville/Jacksonville, FL) Marian Limacher, Michael Perri, Andrew Kaunitz, R. Stan Williams, Yvonne Brinson; (University of Iowa, Iowa City/Davenport, IA) Robert Wallace, James Torner, Susan Johnson, Linda Snetselaar, Jennifer Robinson; (University of Pittsburgh, Pittsburgh, PA) Lewis Kuller, Jane Cauley, N. Carole Milas; (University of Tennessee Health Science Center, Memphis, TN) Karen C. Johnson, Suzanne Satterfield, Rongling Li, Stephanie Connelly, Fran Tylavsky; (Wake Forest University School of Medicine, Winston-Salem, NC) Sally Shumaker, Stephen Rapp, Claudine Legault, Mark Espeland, Laura Coker, Michelle Naughton.

Former Principal Investigators and Project Officers (Albert Einstein College of Medicine, Bronx, NY) Sylvia Wassertheil-Smoller (Baylor College of Medicine, Houston, TX) Haleh Sangi-Haghpeykar, Aleksandar Rajkovic, Jennifer Hays, John Foreyt; (Brown University, Providence, RI) Charles B. Eaton, Annlouise R. Assaf; (Emory University, Atlanta, GA) Lawrence S. Phillips, Nelson Watts, Sally McNagny, Dallas Hall,; (Fred Hutchinson Cancer Research Center, Seattle, WA) Shirley A.A. Beresford, Maureen Henderson; (George Washington University, Washington, DC) Lisa Martin, Judith Hsia, Valery Miller; (Harbor-UCLA Research and Education Institute, Torrance, CA) Rowan Chlebowski (Kaiser Permanente Center for Health Research, Portland, OR) Erin LeBlanc, Yvonne Michael, Evelyn Whitlock, Cheryl Ritenbaugh, Barbara Valanis; (Kaiser Permanente Division of Research, Oakland, CA) Bette Caan, Robert Hiatt; (National Cancer Institute, Bethesda, MD) Carolyn Clifford1; (Medical College of Wisconsin, Milwaukee, WI) Jane Morley Kotchen (National Heart, Lung, and Blood Institute, Bethesda, Maryland) Linda Pottern; (Northwestern University, Chicago/Evanston, IL) Linda Van Horn, Philip Greenland; (Rush University Medical Center, Chicago, IL) Lynda Powell, William Elliott, Henry Black; (State University of New York at Stony Brook, Stony Brook, NY) Dorothy Lane, Iris Granek; (University at Buffalo, Buffalo, NY) Maurizio Trevisan; (University of Alabama at Birmingham, Birmingham, AL) Cora E. Lewis, Albert Oberman; (University of Arizona, Tucson/Phoenix, AZ) Tamsen Bassford, Cheryl Ritenbaugh, Tom Moon; (University of California at Davis, Sacramento, CA) John Robbins; (University of California at Irvine, CA) F. Allan Hubbell, Frank Meyskens, Jr.; (University of California at Los Angeles, CA) Lauren Nathan, Howard Judd1; (University of California at San Diego, LaJolla/Chula Vista, CA) Robert D. Langer; (University of Cincinnati, Cincinnati, OH) Michael Thomas, Margery Gass, James Liu; (University of Hawaii, Honolulu, HI) J. David Curb; (University of Massachusetts/Fallon Clinic, Worcester, MA) Judith Ockene; (University of Medicine and Dentistry of New Jersey, Newark, NJ) Norman Lasser; (University of Miami, Miami, FL) Mary Jo O’Sullivan, Marianna Baum; (University of Minnesota, Minneapolis, MN) Karen L. Margolis, Richard Grimm; (University of Nevada, Reno, NV) Robert Brunner, Sandra Daugherty1; (University of North Carolina, Chapel Hill, NC) Gerardo Heiss, Barbara Hulka, David Sheps; (University of Tennessee Health Science Center, Memphis, TN) Karen Johnson, William Applegate; (University of Texas Health Science Center, San Antonio, TX) Robert Brzyski, Robert Schenken; (University of Wisconsin, Madison, WI) Gloria E. Sarto, Catherine Allen1; (Wake Forest University School of Medicine, Winston-Salem, NC) Mara Vitolins, Denise Bonds, Electra Paskett, Greg Burke; (Wayne State University School of Medicine/Hutzel Hospital, Detroit, MI) Michael S. Simon, Susan Hendrix.

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Crandall, C.J., Aragaki, A.K., Cauley, J.A. et al. Breast tenderness after initiation of conjugated equine estrogens and mammographic density change. Breast Cancer Res Treat 131, 969–979 (2012). https://doi.org/10.1007/s10549-011-1803-9

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Keywords

  • Mammographic density
  • Breast density
  • Breast tenderness
  • Mastalgia
  • Mastodynia
  • Conjugated equine estrogen
  • Medroxyprogesterone acetate