Soft / Text Trials in Breast Cancer

  • In the SOFT / TEXT trials:
    • Premenopausal women:
      • Were given ovarian function suppression with adjuvant aromatase inhibitor or tamoxifen and outcomes were compared to tamoxifen alone for 5 years
  • The SOFT / TEXT trials:
    • Showed a disease-free survival benefit of 2.1% and an 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
  • Tamoxifen alone is still an effective endocrine therapy and would be appropriate if patients choose not to use ovarian function suppression
  • 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


1. 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.

2. 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.

3. 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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