Monaleesa-3 Trial in Metastatic Breast Cancer

  • The CDK 4/6 inhibitors are a class of oral drugs that have been approved for HR+, HER2-negative metastatic breast cancer in the first-line setting or after progression on prior aromatase inhibitor
  • In the MONALEESA-3 trial:
    • Ribociclib in combination with fulvestrant:
      • Showed progression-free survival (20.5 months vs. 12.8 months) and overall survival benefit over fulvestrant alone in HR+, HER2-negative metastatic breast cancer that was either treatment naïve or had up to one prior line of endocrine therapy
  • Everolimus is an mTOR inhibitor with evidence of benefit in the metastatic setting after prior aromatase inhibitor:
    • However it is FDA-approved in combination with exemestane per the BOLERO-2 trial
  • In the metastatic setting:
    • Radiation is generally pursued to palliate symptoms or control isolated disease that is not responding to systemic therapy
  • References
    • Slamon DJ, Neven P, Chia S, Fasching PA1, De Laurentiis M1, Im SA, et al. Phase III randomized study of ribociclib and fulvestrant in hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer: MONALEESA-3. J Clin Oncol. 2018;36(24):2465-2472.
    • Slamon DJ NP, Chia S, et al. Overall survival (OS) results of the phase III MONALEESA-3 trial of postmenopausal patients (pts) with hormone receptor-positive (HR+), human epidermal growth factor 2-negative (HER2-) advanced breast cancer (ABC) treated with fulvestrant (FUL) + ribociclib (rib). Paper presented at: ESMO; September 27 to October 1, 2019, 2019; Barcelona, Spain.
    • Baselga J, Campone M, Piccart M, Burris HA 3rd, Rugo HS, Sahmoud T, et al. Everolimus in postmenopausal hormone-receptor–positive advanced breast cancer. N Engl Med. 2011;366(6):520-529

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