SOFT / TEXT Trials

• In the SOFT / TEXT trials:
  • Premenopausal women were given ovarian function suppression with adjuvant aromatase inhibitor or tamoxifen:
    • Outcomes were compared to tamoxifen alone for 5 years
  • The SOFT / TEXT trials showed a:
    • Disease-free survival benefit of 2.1%
    • Overall survival benefit of 4.3%:
      • At 8 years with GnRH agonist and tamoxifen over tamoxifen alone in the cohort of women who had prior chemotherapy
    • Premenopausal patients with high-risk disease and who received prior chemotherapy:
      • The most effective adjuvant endocrine therapy would include ovarian function suppression with a GnRH agonist per the SOFT / TEXT trials
• Tamoxifen alone:
  • Is still an effective endocrine therapy and would be appropriate if the patient chooses not to use ovarian function suppression
• In premenopausal patients an aromatase inhibitor would be ineffective unless she was rendered post-menopausal
• Raloxifene is a selective ER modulator similar to tamoxifen:
  • It is FDA-approved only for breast cancer risk reduction in post-menopausal women
• Oophorectomy alone is not as effective without additional endocrine therapy.

• References
  • Francis PA, Regan MM, Fleming GF, Lang I, Ciruelos E, Bellet M, et al. Adjuvant ovarian suppression in premenopausal breast cancer. New Engl J Med. 2015;372(5):436-446.
  • Francis PA, Pagani O, Fleming GF, Walley BA, Colleoni M, Lang I, et al. Tailoring adjuvant endocrine therapy for premenopausal breast cancer. N Engl J Med. 2018;379(2):122-137.
  • Vogel VG. The NSABP Study of Tamoxifen and Raloxifene (STAR) trial. Expert review of anticancer therapy. 2009;9(1):51-60.

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