Breast Cancer Research and Treatment

, Volume 98, Issue 2, pp 167–172

Effects of raloxifene on sex steroid hormones and C-telopeptide in postmenopausal women with primary breast cancer

  • Harriet Johansson
  • Bernardo Bonanni
  • Frederique Mariette
  • Massimiliano Cazzaniga
  • Laura Baglietto
  • Aliana Guerrieri-Gonzaga
  • Maria Teresa Sandri
  • Alberto Luini
  • Giuseppe Pelosi
  • Andrea Decensi
Clinical trial


Within a multicentric, double-blind, placebo-controlled phase II trial, postmenopausal women with primary breast cancer were randomized to either 60 or 600 mg daily of raloxifene or placebo administered for 2 weeks prior to surgery. Circulating levels of sex-hormone binding globulin (SHBG), dehydroepiandrosterone-sulfate (DHEA-S), estrone (E1), estrone-sulfate (E1-S), estradiol (E2), and C-terminal telopeptide (CTX), were determined at baseline and the day before surgery in 37 women enrolled at the European Institute of Oncology in Milan. Raloxifene had a statistically significant different effect compared with placebo on SHBG (p<0.001) and E2 (p=0.03), without any dose–response relationship. Women on raloxifene (n=26) showed an increase from baseline of 10.7% (inter-quartile range: 5.9; 24.2) in SHBG and of 1.3% (inter-quartile range: −8.0; 24.5) in E2, whereas women on placebo (n=11) showed a decrease by 15.5% (inter-quartile range: 7.9; 18.1) and 17.3% (inter-quartile range: 6.5; 40.0), respectively. No significant differences were found on the other variables. A positive correlation was observed between DHEA-S and E1-S (p=0.001) or E2 (p<0.001), while SHBG correlated negatively with E1-S (p=0.024) and E2 (p=0.01), and positively with DHEA-S (p=0.016) and CTX (p=0.040). Our results provide evidence for an early endocrine effect of raloxifene which further suggests a favorable impact on breast cancer prevention.


biomarkers bone resorption breast cancer chemoprevention estrogen raloxifene 


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Copyright information

© Springer Science+Business Media, Inc. 2006

Authors and Affiliations

  • Harriet Johansson
    • 1
  • Bernardo Bonanni
    • 1
  • Frederique Mariette
    • 1
  • Massimiliano Cazzaniga
    • 1
  • Laura Baglietto
    • 6
  • Aliana Guerrieri-Gonzaga
    • 1
  • Maria Teresa Sandri
    • 2
  • Alberto Luini
    • 3
  • Giuseppe Pelosi
    • 4
    • 5
  • Andrea Decensi
    • 1
    • 7
    • 8
  1. 1.Division of ChemopreventionEuropean Institute of OncologyMilanItaly
  2. 2.Laboratory MedicineEuropean Institute of OncologyMilanItaly
  3. 3.Division of Breast SurgeryEuropean Institute of OncologyMilanItaly
  4. 4.Division of PathologyEuropean Institute of OncologyMilanItaly
  5. 5.University of Milan School of MedicineMilanItaly
  6. 6.Cancer Epidemiology CentreThe Cancer Council VictoriaMelbourneAustralia
  7. 7.Division of Medical and Preventive OncologyGalliera HospitalGenoaItaly
  8. 8.Division of ChemopreventionEuropean Institute of OncologyMilanItaly

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