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New Indication: Randomized Phase II Trial of Endocrine Therapy With or Without Ribociclib After Progression on Cyclin-Dependent Kinase 4/6 Inhibition in Hormone Receptor–Positive, Human Epidermal Growth Factor Receptor 2–Negative Metastatic Breast Cancer (MBC)

New Indication: Randomized Phase II Trial of Endocrine Therapy With or Without Ribociclib After Progression on Cyclin-Dependent Kinase 4/6 Inhibition in Hormone Receptor–Positive, Human Epidermal Growth Factor Receptor 2–Negative Metastatic Breast Cancer (MBC)
Study:
  • Phase II, double-blind, placebo-controlled trial (MAINTAIN)
  • Patients with HR+, HER2- MBC, whose cancer progressed during ET and CDK4/6i
  • ET+ Ribociclib (n=60) vs. ET (n=59)
Efficacy:
  • mPFS: 5.29 vs. 2.76 mos, HR:0.57, p=0.006
  • 12 mos PFS: 24.6 % vs. 7.4%
Safety:
  • Grade≥ 3: Neutropenia (40% vs.1.7%), AST increased (1.7% vs.6.8%).

Journal of Clin Oncol, JUL 2023

Kalinsky Kevin et al. Randomized Phase II Trial of Endocrine Therapy With or Without Ribociclib After Progression on Cyclin-Dependent Kinase 4/6 Inhibition in Hormone Receptor–Positive, Human Epidermal Growth Factor Receptor 2–Negative Metastatic Breast Cancer: MAINTAIN Trial

http://doi.org/10.1200/JCO.22.02392

Reviewed by Elvin CHALABİYEV, MD on AUG 10, 2023

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