Menopausal Status as Defined in Breast Cancer Clinical Trials

• The definition of menopause:
  • Is defined as the permanent cessation of menses
• The use of the term in breast cancer clinical trials has resulted in a variety of definitions, including:
  • A profound and permanent decrease in ovarian estrogen synthesis
• According to the NCCN guidelines:
  • Reasonable criteria for determining menopause includes the following:
    • History of bilateral oophorectomy
    • Age greater than or equal to 60
    • Age less than 60 and amenorrheic for 12 or more months:
      • In the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression and follicle-stimulating hormone (FSH) and estradiol in the postmenopausal range
    • If taking tamoxifen or toremifene, and age less than 60:
      • Then FSH and plasma estradiol level in postmenopausal ranges
• It is not possible to assign menopausal status:
  • To women who are receiving an LHRH agonist or antagonist
• In women premenopausal at the beginning of adjuvant chemotherapy:
  • Amenorrhea is not a reliable indicator of menopausal status:
    • As ovarian function may still be intact or resume despite anovulation / amenorrhea after chemotherapy:
      • For these women with therapy-induced amenorrhea:
        • Oophorectomy or serial measurement of FSH and/or estradiol:
          • Are needed to ensure postmenopausal status:
            • If the use of aromatase inhibitors is being considered as endocrine therapy
• References:
  • Yu B, Douglas N, Ferrin MJ, et al. Changes in markers of ovarian reserve and endocrine function in young women with breast cancer undergoing adjuvant chemotherapy. Cancer. 2010;116(9):2099-2105.
  • National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines for Oncology: Breast Cancer. https://www.nccn.org/professionals/physician_gls/f_guidelines.asp Published January 2016. Accessed January 31, 2017.

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