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Area of Science:

  • Oncology
  • Genomics
  • Clinical Trials

Background:

  • The 21-gene recurrence score predicts chemotherapy benefit in early-stage, lymph-node-negative breast cancer.
  • Its utility in lymph-node-positive breast cancer remains unclear.

Purpose of the Study:

  • To evaluate the chemotherapy benefit in hormone-receptor-positive, HER2-negative breast cancer with 1-3 positive lymph nodes and a low recurrence score (≤25).
  • To determine if menopausal status influences chemotherapy benefit.

Main Methods:

  • Prospective randomized trial comparing endocrine therapy alone versus chemoendocrine therapy.
  • Participants: 5018 women with 1-3 positive lymph nodes and recurrence score ≤25.
  • Primary endpoint: invasive disease-free survival.

Main Results:

  • Chemotherapy benefit varied by menopausal status (P=0.008).
  • Postmenopausal women showed no significant invasive disease-free survival benefit (HR 1.02, P=0.89).
  • Premenopausal women had improved invasive disease-free survival (HR 0.60, P=0.002) and distant relapse-free survival (HR 0.58, P=0.009) with chemoendocrine therapy.

Conclusions:

  • Premenopausal women with 1-3 positive lymph nodes and low recurrence score benefit from adjuvant chemotherapy.
  • Postmenopausal women with similar characteristics do not benefit from adjuvant chemotherapy.
  • Chemotherapy benefit was not influenced by the recurrence score in this population.