New-onset breast tenderness after initiation of estrogen plus progestin therapy and breast cancer risk.

Full Abstract

BACKGROUND: Estrogen plus progestin therapy increases breast cancer incidence and breast tenderness. Whether breast tenderness during estrogen plus progestin therapy is associated with breast cancer risk is uncertain. METHODS: We analyzed data from the Women's Health Initiative Estrogen + Progestin Trial, which randomized postmenopausal women with an intact uterus to receive daily conjugated equine estrogens, 0.625 mg, plus medroxyprogesterone acetate, 2.5 mg (n = 8506), or placebo (n = 8102). At baseline and annually, participants underwent mammography and clinical breast examination. Self-reported breast tenderness was assessed at baseline and at 12 months. The incidence of invasive breast cancer was confirmed by medical record review (mean follow-up of 5.6 years). RESULTS: Of women without baseline breast tenderness (n = 14,538), significantly more assigned to receive conjugated equine estrogens plus medroxyprogesterone vs placebo experienced new-onset breast tenderness after 12 months (36.1% vs 11.8%, P < .001). Of women in the conjugated equine estrogens plus medroxyprogesterone group, breast cancer risk was significantly higher in those with new-onset breast tenderness compared with those without (hazard ratio, 1.48; 95% confidence interval, 1.08-2.03; P = .02). In the placebo group, breast cancer risk was not significantly associated with new-onset breast tenderness (P = .97). CONCLUSIONS: New-onset breast tenderness during conjugated equine estrogens plus medroxyprogesterone therapy was associated with increased breast cancer risk. The sensitivity and specificity of the association between breast tenderness and breast cancer were similar in magnitude to those of the Gail model. Trial Registration clinicaltrials.gov Identifier: NCT00000611.

Author information

Author/s: Crandall, Carolyn J (CJ); Aragaki, Aaron K (AK); Chlebowski, Rowan T (RT); McTiernan, Anne (A); Anderson, Garnet (G); Hendrix, Susan L (SL); Cochrane, Barbara B (BB); Kuller, Lewis H (LH); Cauley, Jane A (JA);

Affiliation: Department of Medicine, David Geffen School of Medicine at University of California, UCLA Medicine/GIM, Los Angeles, CA 90024, USA. ccrandall(-atsign-)mednet.ucla.edu

Grants: 5K12 AG01004-08 (Agency:NIA NIH HHS) ; N01WH22110 (Agency:WHI NIH HHS) ; N01WH24152 (Agency:WHI NIH HHS) ; N01WH32100-2 (Agency:WHI NIH HHS) ; N01WH32105-6 (Agency:WHI NIH HHS) ; N01WH32108-9 (Agency:WHI NIH HHS) ; N01WH32111-13 (Agency:WHI NIH HHS) ; N01WH32115 (Agency:WHI NIH HHS) ; N01WH32118 (Agency:WHI NIH HHS) ; N01WH32119 (Agency:WHI NIH HHS) ; N01WH32122 (Agency:WHI NIH HHS) ; N01WH42107-26 (Agency:WHI NIH HHS) ; N01WH42129-32 (Agency:WHI NIH HHS) ; N01WH44221 (Agency:WHI NIH HHS)

Journal and publication information

Publication Type: Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't

Journal: Archives of internal medicine (Arch Intern Med), published in United States. (Language: eng)

Reference: 2009-Oct; vol 169 (issue 18) : pp 1684-91

Dates: Created 2009/10/13; Completed 2009/11/04;

PMID: 19822825, status: MEDLINE (last retrieval date: 11/4/2009, IMS Date: )

Sourced from the National Library of Medicine. Abstract text and other information may be subject to copyright.

External Links for this article
(including full text providers, if available):

Click Electronic Full-text Provider Links to see options for finding the electronic full text links to this article. Note there may be a subscription or fee required for access to the full text. See our FAQ for information on finding FREE full text articles.

This article may also be located in paper journal collections available in many libraries. Use the Journal and Publication Information above to find the full article.