Initial ribociclib plus endocrine therapy for HR+/HER2- advanced breast cancer in pre- and postmenopausal Chinese women: Primary results from a phase 2 randomized study

Cancer Med. 2024 Aug;13(15):e7408. doi: 10.1002/cam4.7408.

Abstract
in English, French

Background: The MONALEESA‐7 and ‐2 phase 3 randomized trials demonstrated a statistically significant progression‐free survival (PFS) and overall survival (OS) benefit with initial ribociclib + endocrine therapy (ET) versus placebo + ET in pre‐ and postmenopausal patients with hormone receptor–positive (HR+)/human epidermal growth factor receptor 2–negative (HER2−) advanced breast cancer (ABC), respectively. Similar trends were observed in Asian subgroup analyses. This phase 2 bridging study of initial ET + ribociclib enrolled pre‐ and postmenopausal patients with HR+/HER2– ABC from China and was conducted to demonstrate consistency of PFS results in a Chinese population relative to the global MONALEESA‐7 and ‐2 studies.

Methods: Patients were randomized (1:1) to ET (nonsteroidal aromatase inhibitor + goserelin for premenopausal patients; letrozole for postmenopausal patients) + either ribociclib or placebo. The primary endpoint was investigator‐assessed PFS.

Results: As of April 25, 2022, the median follow‐up was 34.7 months in both cohorts. In the premenopausal cohort, median PFS was 27.6 months in the ribociclib arm (n = 79) versus 14.7 months in the placebo arm (n = 77) (hazard ratio 0.67 [95% CI: 0.45, 1.01]). In the postmenopausal cohort, median PFS was not reached in the ribociclib arm versus 18.5 months in the placebo arm (n = 77 in each arm) (hazard ratio 0.40 [95% CI: 0.26, 0.62]). Data also suggested improvements in secondary efficacy endpoints, although OS data were not mature. The safety profile in this population was consistent with that in global studies.

Conclusions: These data demonstrate a favorable benefit–risk profile for ribociclib + ET in Chinese patients.

Publication types

  • Randomized Controlled Trial
  • Clinical Trial, Phase II
  • Multicenter Study

MeSH terms

  • Adult
  • Aged
  • Aminopyridines* / administration & dosage
  • Aminopyridines* / adverse effects
  • Aminopyridines* / therapeutic use
  • Antineoplastic Combined Chemotherapy Protocols* / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols* / therapeutic use
  • Aromatase Inhibitors / administration & dosage
  • Aromatase Inhibitors / therapeutic use
  • Breast Neoplasms* / drug therapy
  • Breast Neoplasms* / metabolism
  • Breast Neoplasms* / mortality
  • Breast Neoplasms* / pathology
  • China
  • East Asian People
  • Female
  • Goserelin / administration & dosage
  • Goserelin / therapeutic use
  • Humans
  • Letrozole* / administration & dosage
  • Letrozole* / therapeutic use
  • Middle Aged
  • Postmenopause*
  • Premenopause
  • Progression-Free Survival
  • Purines* / administration & dosage
  • Purines* / adverse effects
  • Receptor, ErbB-2* / metabolism
  • Receptors, Estrogen* / metabolism
  • Receptors, Progesterone / metabolism

Substances

  • Aminopyridines
  • ribociclib
  • Purines
  • Receptor, ErbB-2
  • Receptors, Estrogen
  • ERBB2 protein, human
  • Letrozole
  • Receptors, Progesterone
  • Goserelin
  • Aromatase Inhibitors