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Three years of the CDK4/6 inhibitor ribociclib added to hormone therapy reduced relapses in stage II-III hormone-receptor-positive breast cancer, including some node-negative patients.
Open-label phase 3 trial of 5,101 patients with hormone-receptor-positive, HER2-negative stage II or III early breast cancer, including node-negative patients with high-risk features, randomised to a non-steroidal aromatase inhibitor with or without three years of ribociclib at a reduced dose (400 mg daily). Primary endpoint was invasive disease-free survival.
Three-year iDFS was 90.4% vs 87.1% (HR 0.75). Together with monarchE it established adjuvant CDK4/6 inhibition, but in a broader, lower-risk population and with a longer, lower-dose schedule.
Ribociclib is a second adjuvant CDK4/6 option, and the only one with data in node-negative stage II disease. Roughly 3 in 100 patients avoid a relapse or death at three years, so the decision depends heavily on individual risk, tolerance of a three-year oral drug, and cost. Whether the benefit persists after treatment ends, as it did with abemaciclib, needs longer follow-up.
Shares Miguel Martín, NATALEE, monarchE, High-risk early HR-positive breast cancer.
Shares Gabriel N. Hortobagyi, Ribociclib, CDK4/6, Estrogen receptor (ERα).
Shares monarchE, CDK4/6, Estrogen receptor (ERα), CDK4/6 inhibitors.
Shares Miguel Martín, High-risk early HR-positive breast cancer, CDK4/6, CDK4/6 inhibitors.
Shares Ribociclib, CDK4/6, Estrogen receptor (ERα), HR-positive / HER2-negative breast cancer.
Shares Carlos Barrios, Seock-Ah Im, Binghe Xu, HR-positive / HER2-negative breast cancer.
Shares Hazard ratio (HR), Dormant cells and minimal residual disease, Neoadjuvant / adjuvant / perioperative, New England Journal of Medicine.
Shares Binghe Xu, CDK4/6, CDK4/6 inhibitors, HR-positive / HER2-negative breast cancer.